1 Cosmetic Products Notification Portal (CPNP) User Manual This manual is intended for all CPNP users. It explains the main functions of the CPNP. 'CPNP users' means: - Cosmetic industry responsible persons and users acting on their behalf - referred to in this User Manual as 'responsible persons'; - Distributors who make available in a Member State a cosmetic product already placed on the market in another Member State and translate, on their own initiative, any element of the labelling of that product in order to comply with national law - referred to in this User Manual as 'distributors'; - National Competent Authorities, in charge of market surveillance, market analysis, evaluation and consumer information regarding cosmetic products - referred to in this User Manual as 'competent authorities'; - Poison Centres or similar bodies, where such centres or bodies have been established by Member States - referred to in this User Manual as 'poison centres'. Manual readers are kindly invited to report any remark on this User Manual to sanco-cpnp@ec.europa.eu Last update on 26/01/2012
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Cosmetic Products Notification Portal (CPNP) User Manual
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Cosmetic Products Notification Portal (CPNP)
User Manual
This manual is intended for all CPNP users. It explains the main functions of the CPNP.
'CPNP users' means:
- Cosmetic industry responsible persons and users acting on their behalf - referred to in this User Manual as 'responsible persons'; - Distributors who make available in a Member State a cosmetic product already placed on the market in another Member State and translate, on their own initiative, any element of the labelling of that product in order to comply with national law - referred to in this User Manual as 'distributors'; - National Competent Authorities, in charge of market surveillance, market analysis, evaluation and consumer information regarding cosmetic products - referred to in this User Manual as 'competent authorities'; - Poison Centres or similar bodies, where such centres or bodies have been established by Member States - referred to in this User Manual as 'poison centres'.
Manual readers are kindly invited to report any remark on this User Manual to
I. INTRODUCTION AND SYSTEM REQUIREMENTS............................................................................... 3 I.1 INTRODUCTION................................................................................................................................... 3
I.1.1 Key terms ...................................................................................................................................... 3 I.1.2 What is the Cosmetic Products Notification Portal (CPNP)?....................................................... 5 I.1.3 What information needs to be entered into the CPNP? ................................................................ 5 I.1.4 What the CPNP does with the information entered? .................................................................... 5 I.1.5 When information has to be entered into CPNP? ......................................................................... 5
I.2 SYSTEM REQUIREMENTS.................................................................................................................. 6 I.3 REGISTRATION .................................................................................................................................... 6
I.3.1 General overview of the workflow ............................................................................................... 6 I.3.2 How do I get my ECAS login and password? .............................................................................. 8 I.3.3 How can I login/request an access to CPNP? ............................................................................. 12
II. USING CPNP............................................................................................................................................. 17 II.1 CPNP HOME PAGE............................................................................................................................ 17
ANNEX I: Rules on specific ingredients of concern and/or the pH value ..................................................... 61 ANNEX II: Frame formulations ..................................................................................................................... 69 ANNEX III: Categories of cosmetic products .............................................................................................. 222
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I. INTRODUCTION AND SYSTEM REQUIREMENTS
I.1 INTRODUCTION
I.1.1 Key terms Some key terms used in this User Manual are reproduced here for ease of reference: I.1.1.1 Cosmetic product ‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. I.1.1.2 Distributor 'Distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market. I.1.1.3 Making available on the market 'Making available on the market' means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge. I.1.1.4 Placing on the market ‘Placing on the market’ means the first making available of a cosmetic product on the Community market. I.1.1.5 Importer ‘Importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market. I.1.1.6 Nanomaterial ‘Nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm I.1.1.7 Frame formulation ‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. I.1.1.8 Responsible person
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For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person. The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing. Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing. For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market. The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected. I.1.1.9 CMR substances Substances classified as carcinogenic, mutagenic or toxic for reproduction pursuant to Regulation (EC) No 1272/20081. I.1.1.10 CosIng It is a European Commission database that contains information on cosmetic substances and ingredients2. I.1.1.11 SAAS It is the Sanco Autentication and Authorisation System. It provides the user with a profile and access rights for a specific European Commission application. This application manages specifically the access rights. I.1.1.12 ECAS It is the European Commission Authentication Service. It provides the user with a login and password to connect to multiple European Commission applications. This application manages specifically logins and passwords. I.1.1.13 Local administrator 1 OJ L353, 31.12.2008, p.1 2 http://ec.europa.eu/consumers/cosmetics/cosing/
A local administrator is the person in charge of managing the access requests of a specific organisation. I.1.1.14 Organisation An organisation means either a 'responsible person' (or its subcontractors), a 'distributor', a 'competent authority' or a 'poison centre'.
I.1.2 What is the Cosmetic Products Notification Portal (CPNP)? The CPNP is the online notification system created for the implementation of Regulation (EC) N° 1223/2009 of the European Parliament and of the Council on cosmetic products3.
It is important to note that the fact that a product has been succesfully notified
through the CPNP does not necessarily mean that the product in question fulfills all the requirements of the Regulation (EC) N° 1223/2009 of the European
Parliament and of the Council on cosmetic products.
I.1.3 What information needs to be entered into the CPNP? Article 13 of Regulation (EC) N° 1223/2009 lists the information that the responsible persons and, under certain circumstances, the distributors of cosmetic products shall notify through the CPNP about the products they place or make available on the European market.
I.1.4 What the CPNP does with the information entered? The CPNP makes some of this information available electronically to the competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information) and to the poison centres, or similar bodies established by Member States (for the purposes of medical treatment).
I.1.5 When does information have to be entered into CPNP? As from 11 January 2012, a responsible person will have the possibility to notify through CPNP, by way of derogation from Directive 76/768/EEC, the information referred to in Article 13(1) and (2) of Regulation (EC) No 1223/2009. As from 11 July 2013, the use of CPNP will become mandatory.
As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law,
3 OJ L342, 22.12.2009, p.59
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will have to submit into CPNP the information referred to in Article 13(3) of Regulation (EC) N° 1223/2009.
Where a cosmetic product has been placed on the market before 11 July 2013, but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor will have to communicate the information referred to in Article 13(4) of Regulation (EC) N° 1223/2009 to the responsible person. On the basis of that communication, the responsible person shall notify through CPNP the information referred to in paragraph 1 of Article 13 of Regulation (EC) N° 1223/2009, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.
I.2 SYSTEM REQUIREMENTS The following items are required to connect to the CPNP:
- An Internet connection;
- A computer screen resolution of at least 1024 X 768 pixels. The CPNP is optimized for Microsoft Internet Explorer 7 or Mozilla Firefox 2 (Internet Explorer with JavaScript and cookies enabled);
Note: this User Manual explains the online use of the CPNP. In the future, there will be also the possibility for Responsible Persons to notify directly from machine-to-machine. This will be further detailed in this User Manual once this functionality is implemented.
I.3 REGISTRATION In order to access the CPNP, the user needs a user login and password. Two systems are needed: - The European Commission Authentication Service (ECAS). This system provides the user with a login and password to connect to multiple European Commission applications. - The SANCO Authentication and Authorisation System (SAAS). This system provides the user with a profile and access rights for a specific European Commission application, in this case the CPNP.
I.3.1 General overview of the workflow A user that accesses the CPNP for the first time need to follow a 3 step-procedure 1. Create his ECAS login/password
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2. Request an access to CPNP 3. Connect to CPNP All CPNP users should be part of what is called an 'organisation'. An organisation means either a 'responsible person' (or its sub-organisations), a 'distributor', a 'competent authority' or a 'poison centre'. There are two situations that a new user may face: 1. The organisation she/he belongs to already exists in SAAS
In this situation, the user only needs to ask for an access to this organisation. The local administrator(s) of this organisation will have the possibility to accept or refuse the access request.
2. The organisation does not yet exist in SAAS. In this situation, the user has to create the organisation in SAAS. The Commission services have to validate this new organisation and to accept or refuse the access request submitted by the user. The user who creates a new organisation becomes automatically a local administrator of this organisation and in the future he will be able to manage all access requests related to that organisation.
Note: A local administrator can designate additional local administrator(s) for her/his organisation and for each of its sub-organisations (see section 1.3.3.3 for further details) provided that these future new local administrator(s) already exist in SAAS and have access to CPNP for the (sub-) organisation. To do so, the local administrator has to select the future new local administrator in the list of active access profiles, in the main page of SAAS, click on the login of the the future new local administrator and tick the checkbox "Local admin". As any other local administrator, the new local administrator(s) will be able to accept or refuse access requests, designate other local administrators, create new suborganisations, etc.
For security reasons, only local administrators who have been formally nominated by the Member States beforehand will be allowed to create an organisation 'Competent Authority' or an organisation 'Poison Centre' in SAAS.
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I.3.2 How do I get my ECAS login and password?
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I.3.2.1 Connect to the ECAS registration website The user has to connect to https://webgate.ec.europa.eu/aida/selfreg and complete the following fields:
Username First name Last name E-mail Preferred language
To submit his request, the user has to: 1. Tick the checkbox to aknowledge that he has read and understood the privacy statement 2. Type the security characters displayed in the image.
Once the registration is sent, the system will display the following confirmation page:
I.3.2.2 Register a password After the submission of the ECAS registration form, an e-mail will be sent to the user e-mail address. This e-mail will allow the user to complete the registration process by choosing a password.
Once the user has clicked on the link specified in the e-mail, the following page will be displayed:
Click on the link and you will be automatically redirected to the Password registration page
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The user has then to type the password of her/his choice, following these specific recommendations keeping in mind that the password may not include his username and must contain at least 10 characters chosen from at least three of the following character groups (no other characters are permitted apart from the white space):
Upper case: A to Z Lower case: a to z Numeric 0 to 9 Special character:
Once the user has entered her/his password and clicked on the submit button, a confirmation page will be displayed:
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I.3.3 How can I login/request an access to CPNP?
I.3.3.1 Login to CPNP using your ECAS credentials The user has to open a new browser and connect to CPNP at the following address: https://webgate.ec.europa.eu/cpnp The system will automatically redirect the user to the ECAS login page.
ECAS will first ask the user if she/he works for a European institution or not. The user has to:
1. Select 'I do not work for a European institution'; 2. Tick the checkbox 'Remember my choice'. Next time the user will try to
connect to CPNP (or any other Commission's application), ECAS will not ask her/him again if he works for the European institutions or not;
The user has to enter her/his ECAS username and password and click on . The user will be then redirected to the following confirmation page:
After a few seconds, ECAS will redirect the user to CPNP.
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If the user has no access to the CPNP, or if her/his access request has not yet been validated by a local administrator, she/he will see the following screen.
If the user already has access to CPNP, she/he will be redirected to the CPNP homepage.
I.3.3.2 Request an access to CPNP On the "Access denied" page, there is a link that allows the user to be redirected to SAAS and submit a new access request form. Once redirected to SAAS, the user will see the following screen, allowing her/him to submit a new access request:
Click on the link to submit a new access request form
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In a first dropdown, the user will see that the 'Cosmetic Products Notification Portal' application has been selected by default. Please do not select another application. Then the user has to select an organisation in the list of existing organisations for CPNP. If the organisation she/he belongs to is not yet created in SAAS, she/he can create it by clicking on the 'Create organisation' button. The user has then to select the access profile she/he is entitled to have:
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• Competent Authority; • Distributor; • Poison Centre; • Responsible Person. When the user clicks on the 'Submit' button, his request is sent to: 1. the local administrator(s) of the selected organisation (if is not a new organisation) and the European Commission services. 2. the European Commission services only (if it is a new organisation) Note: access can be granted also for a limited period of time. Note: all organisations created in SAAS are visible to all SAAS users. Once the registration request has been completed, the user sees the following page:
On this page, the user can see all her/his current access requests concerning CPNP, but also a summary of all her/his previous access requests (active or locked).
1.3.3.3 Delegation mechanisms in SAAS
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A Responsible Person can decide to delegate the notification of its products to suborganisations via the subdelegation mechanism implemented into SAAS. This function is useful for instance when notifications are to be done by another entity (e.g. a consultant) on behalf of the Responsible Person, or when a Responsible Person wants to separate its notifications by brands or type of products. Organisations in SAAS are structured as follows: - The level 1 is the 'parent' organisation. It is always the Responsible Person. - Below level 1, there is the possibity to have suborganisations linked to the Responsible Person. These suborganisations can enter notifications into the CPNP on behalf of that Responsible Person. The notifications done by a user belonging to a suborganisation are visible and editable by any user of this suborganisation. These notifications are also visible (but not editable) by the Responsible Person. How to create a sub-organisation in SAAS? There are two possibilities to create a suborganisation in SAAS: - when a user request an access to CPNP, she/he has the possibility to select an existing suborganisation or to create a new one. The local administrator of the 'parent' organisation will have to accept or refuse the creation of the new suborganisation and any access to that suborganisation. - A local administrator of an organisation also has the possibility to create new suborganisations by clicking on the 'Create new' button.
II. USING CPNP
II.1 CPNP HOME PAGE Depending on the user profile (i.e. responsible person, distributor, competent authority or poison centre), the home pages and subsequent screens may differ. This is detailed throughout this user manual.
II.1.1 Confidentiality aspects Some of the data contained in CPNP are business confidential information. For this reason, the following warning message is displayed on the home page for the competent authorities and for the poison centres, when they connect to the CPNP:
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Competent authorities and poison centres will have to click on to be able to proceed further.
II.1.2 Navigation buttons The following tabs may be displayed on the home page, depending on the user profile:
II.1.2.1 ‘Home’ tab It allows the users to go back to the homepage.
II.1.2.2 ‘Products’ tab - Notify a single component product
This menu item is only displayed for the responsible persons.
It allows the responsible persons to create notifications for single component products.
- Notify a multi-component product
This menu item is only displayed for responsible persons.
It allows the responsible persons to create notifications for products that contain several components.
- Advanced search
This menu item is displayed for responsible persons, competent authorities and poison centres.
It allows these users to search for products or components on the basis of several criteria.
- Simple search
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This menu item is displayed for responsible persons, competent authorities and poison centres.
It allows these users to search for products or components, using key words.
- Responsible person search
This menu item is displayed for competent authorities and poison centres only.
It allows these users to search for the responsible persons existing in the system, and then to see all their submitted notifications.
Important notice
A responsible person or a distributor can search for and display only the products it (or a user acting on its behalf) has entered into the system.
This means that the products of one responsible person or of one distributor are not accessible to another responsible person or distributor in the system. A responsible
person or a distributor can search for its draft and submitted notifications.
Competent authorities and poison centres can search for all submitted notifications contained in the system. Draft notifications are not accessible to competent authorities
and poison centres.
II.1.2.3 'Contact persons' tab This tab is displayed for responsible persons onl.
It allows the responsible persons to manage the contact details of the contact persons associated to their organisation on a bulk basis.
II.1.2.4 'Distributors' tab This tab is displayed for distributors only.
It allows the distributors to enter distribution notifications and to search for the notifications they have already entered in the system.
II.1.2.5 ‘Useful links’ tab This tab is displayed for all users.
It shows links to CPNP User Manual, the CosIng database and the Regulation on cosmetic products.
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II.1.2.6 ‘Privacy Statement’ This item is displayed for all users. It shows the CPNP privacy statement.
II.1.2.7 ‘Contact’ This item is displayed for all users. It allows the user to send an email to the CPNP functional mailbox.
II.1.2.8 ‘Profile’ This item is displayed for all users.
It allows the users to check their profile in CPNP
II.1.2.9 ‘Language’ This item is displayed for all users.
It allows the users to change the interface language.
Note: The CPNP interface has been initially created in English and then translated. Therefore, in case of doubt, please use the English version as reference and do not hesitate to report to [email protected] any inconsistency you would find in any other language.
II.1.2.10 ‘Log out’ This item is displayed for all users
It logs the user out of the system.
II.2 NOTIFICATIONS PURSUANT TO ARTICLE 13(1) and (2) -SINGLE COMPONENT PRODUCT This function is only accessible to the responsible persons. A 'single component product' refers to a product that is composed of one single element (e.g. a single bottle of shampoo). To create a notification for a single component product, the responsible person has to click on ‘Notify a single component product' in the ‘Products’ tab:
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The general form for the notification of a single component product will be displayed. Two different tabs are available: ‘General information’ and ‘Product details’.
II.2.1 ‘General information’ tab The ‘General information’ tab allows the responsible person to enter the following information about the product:
II.2.1.1 Product name
The product name is a crucial element of the notification since it will be often used by competent authorities or by poison centres to search for a product in the CPNP. The product name must be detailed enough to enable the specific identification of the cosmetic product. The product name should include the trade mark/brand, the product line and the specific name of the product as they appear on the product. The complete name should include the function unless it is part of the specific name of the product. Example: 1. - Trade Mark / Brand 2. - Product Line
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3. - Specific name (function included) The complete name of the product is: Trade Mark / Brand + Product Line + specific name (function included), e.g.: Trade Mark / Brand Repair &Shine smoothing cream Trade Mark / Brand Repair &Shine smoothing conditioner Trade Mark / Brand Repair &Shine smoothing shampoo lemon Trade Mark / Brand Repair &Shine smoothing shampoo orange Trade Mark / Brand Repair &Shine smoothing shampoo vanilla
II.2.1.2 Language When the product is made available on the market with a name translated in different languages, each of these names has to be mentioned in the notification together with the corresponding language (selected via the drop down menu). The symbol next to the language drop down menu allows the responsible person
to add product name translation(s) and to select the corresponding language(s). If the responsible person wants to delete a product name translation, it has to click on the button next to the corresponding translation.
If the product name is the same in all languages, the responsible person can indicate this name only once and select ‘multilingual’ in the drop down menu.
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When 'multilingual' has been selected, the following warning message will be displayed:
'Multilingual' cannot be used in case the product name is the same in some languages, but different in others. In this case, all linguistic versions of the product name have to be entered individually in the system. Even when the name is the same for some languages, it has to be repeated indicating for each one the corresponding language.
II.2.1.3 Shades (if applicable) To avoid unnecessary notifications, the responsible person may notify the different shades of a product (e.g. different shades of a lipstick) into one single notification. This can be done only if all these shades are fully covered by the information contained in the notification.
Important notice
The different shades shall be indicated in the shades field and shall be clearly separated by a " / " preceded and followed by a white space.
The translations of these shades in the different languages have to be indicated in the shades field just below the corresponding linguistic version of the product name. When some shades of a cosmetic product are not fully covered by the information contained in the notification (e.g. different composition information), these shades must be notified separately.
II.2.1.4 Product specifically intended for children under 3 years of age The responsible person must indicate whether the product is specifically intended for children under 3 years of age.
II.2.1.5 Responsible person details
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The notification shall contain at least the name and the address of the responsible person. These data appear on the left part of the screen under 'Responsible person'. They are automatically retrieved from SAAS on the basis of the login of the user. When the responsible person needs to update or correct its details, it has to be done in SAAS. Access to SAAS is available from the profile item located at the top right of the CPNP screen. Only local administrators can modify the responsible person details.
Important notice
In case the name and the address of the responsible person are not complete in SAAS, the following warning message will be displayed and the responsible person will not be
allowed to enter any notification in the system until the information is complete.
II.2.1.6 Contact person details
For each notification, the responsible person has to indicate the contact details of a physical person to contact in case of necessity.
In the notification form, the system will display the list of all the contact persons that are linked to the responsible person.
If a contact person does not yet appear in the list of contact persons, this contact person
can be added by clicking on the button and by entering the contact person details
into the system. All mandatory fields are indicated by a "*".
There are two buttons at the bottom right of the screen.
allows the responsible person to add the new contact person to the ongoing notification.This contact person will become selectable in the drop down menu for future notifications by this responsible person.
aborts the operation.
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Note: As soon as a new contact person is created in the CPNP, an e-mail will be sent to this contact person by the CPNP. This email contains information on data protection aspects.
Important notice
All phone and fax numbers entered in the CPNP must include the international prefix Example: 0032 2 296 93 62
A specific module has been created in the CPNP for the management of contact person details on a bulk basis. To access this module the responsible person has to click on the 'Contact persons' tab on the top left of the screen.
By selecting 'List' in the Contact persons tab, the responsible person can then either search for one contact person using the search field or display all contact persons by clicking on 'All contact persons'. The responsible person can then edit the contact person details (by clicking on or delete them by clicking on ).
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The responsible person can create new contact person(s) by selecting 'New contact person' in the Contact persons tab.
II.2.1.7 Product no longer manufactured When a product is no longer manufactured the responsible person may indicate it.
II.2.1.8 Product ready to go on the market or already on the market If the product is ready to go on the market or is already on the market, the responsible person has to tick the box.
If all mandatory fields are filled and the product is not indicated as being ready to go on the market or already on the market, the responsible person will be allowed to submit its notification without the original labelling and corresponding packaging being attached. However, the following warning message will be displayed:
Important notice
To fulfil its legal obligations, the responsible person has to notify once the original labelling, and, where reasonably legible, a photograph of the corresponding
packaging at the latest when the product is placed on the market.
II.2.1.9 Product imported in the Community The responsible person has to indicate if the product is imported in the Community, and if so, it has to select the country of origin in the drop down menu.
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Important notice
There may be rare cases where the same product is imported from several countries.
In such cases, the responsible person shall make one notification per country of origin and shall mention the country of origin into brackets in the product name.
Trade Mark / Brand Repair &Shine smoothing cream (China)
Important notice
There may be rare cases where the same product may be both imported and not imported.
In such cases, the responsible person shall make two different notifications, i.e. one
notification for the imported version of the product (specifying the country of origin into brackets in the product name) and another notification for the non-imported version of the
product.
II.2.1.10 Member State of first placing on the market The responsible person has to select the Member State of first placing on the market in the drop down menu.
II.2.1.11 'Save as draft', 'Notify' and 'Cancel' There are three buttons at the top and at the bottom of the screen.
: The notification is saved as draft but not notified. A notification can be saved as draft without all the required fields being filled. To save a notification as draft, at least a product/component name and the corresponding language must be filled (indicated by "**").
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: The notification is complete and will be made available to poison centres and competent authorities. It will then be not possible to delete this notification from the system. Only update or correction will be possible. A notification can be notified only when all mandatory fields indicated by a "*" are filled in. If some mandatory information is missing, the system will display a warning message and will indicate the field(s) that still needs to be filled in.
: The ongoing operation is aborted.
II.2.2 ‘Product details’ tab The product details tab is composed of three different sections:
II.2.2.1 Section CMR & Nanomaterials
In this section the responsible person has to indicate if the product contains:
- Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008, and
- Substances in the form of nanomaterials.
II.2.2.1.1 CMR If the responsible person clicks 'yes' to the question ‘Does the product contain CMR substances of category 1A or 1B?’, he has to indicate the ‘Name’ of the CMR substance of category 1A or 1B and its ‘CAS’ or 'EC Number'.
To help the responsible person, the name and information on CAS and EC numbers will be retrieved from CosIng, when available, but the responsible person remains
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responsible for checking the completeness and the exactness of the information provided and changing it where necessary. The responsible person can also manually type a CMR substance of category 1A or 1B and its CAS and/or EC number if it is not included in CosIng.
If there is more than one CMR substance of category 1A or 1B in the product, they can be
added by clicking on the button .
Important notice
When retrieving information from CosIng, please note that there is no filter intended to display only CMR 1A or 1B.
II.2.2.1.2 Nanomaterials
If the responsible person answers 'Yes' to the second question ‘Does the product contain nanomaterials?’ the following screen will be displayed:
The CPNP will first ask the responsible person to answer two questions on the exposure conditions:
- Is the product a rinse off or a leave on product?
- What is the exposure route (dermal, oral and/or inhalation)?
To add a nanomaterial to the notification the responsible person has to click on . A pop up page will appear and the responsible person can then search for the nanomaterial into CosIng by entering at least 5 characters:
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The responsible person can then select one of the proposed nanomaterials (by clicking on the button next to the nanomaterial to be added). A new screen will appear and display the information retrieved from CosIng i.e. INCI, IUPAC, INN, XAN, CAS number, EINECS and/or ELINCS. Here too, the responsible person remains responsible for checking the completeness and the exactness of the information provided and changing it where necessary.
Important notice
When retrieving information from CosIng, please note that there is no filter intended to display only nanomaterials.
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If the responsible person clicks on , the nanomaterial will be added to the notification.
If the responsible person clicks on , the nanomaterial will not be added to the notification and the responsible person will be redirected to the search screen. By clicking on 'new nanomaterials' the responsible person can also type a nanomaterial if the name is not included in CosIng.
II.2.2.2 Section Category & Frame formulation In this section, the responsible person has to enter information on:
II.2.2.2.1 Category of cosmetic product The responsible person has to select three category levels, starting by the level 1, followed subsequently by level 2 and 3.
Important notice In some rare cases, products may have several 'functions' that may make them fall under different categories. In these cases, it is the primary function that has to be considered for
the categorisation of the cosmetic product. The choice of a category at level 1 determines the categories available at level 2; the choice of a category at level 2 will determine the categories available at level 3.
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All existing categories are available for consultation in Annex III to this User Manual.
II.2.2.2.2 Physical form The responsible person has to select the physical form of the product in the drop down menu.
II.2.2.2.3 Special applicator/packaging When the product is not presented in a typical non-pressurised cosmetic packaging (e.g. bottle, jar, or sachet) but in a special applicator or packaging, the responsible person has to mention it. This information might allow poison centres to modulate their risk assessment in case of emergency medical treatment.
By clicking on the responsible person can see the possible choices in terms of special applicators and packagings. If the answer is 'yes', the responsible person has to select the applicator/packaging from the drop down menu.
If the responsible person selects ‘other’ in the drop down menu, the responsible person is invited to suggest an applicator / packaging denomination (preferably in English). All applicator / packaging suggested names will be taken into consideration by the CPNP maintenance group in order to create new applicator/packaging names, or update the existing ones, where necessary.
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II.2.2.2.4 Formulation name Depending on the categories selected at levels 1, 2 and 3, the CPNP will propose a list of possible formulation names in a drop down menu. The responsible person has to select the relevant formulation name. The formulation name provides a more detailed product categorisation, which is made available to poison centers only.
Important notice
Choosing a formulation name does not mean that the responsible person will notify his product using a predefined frame formulation. After having selected a formulation name the responsible person will still have the choice to notify using a predefined frame formulation, an exact concentration declaration or a concentration ranges declaration. If the responsible person selects ‘other’ the responsible person is invited to suggest a formulation name (preferably in English). All suggested names will be taken into consideration by the CPNP maintenance group in order to create new formulation names, or update those existing, where necessary.
Only in cases where the responsible person has no suggestion for any formulation name, the responsible person may simply repeat the name selected for the level 3 category.
II.2.2.2.5 Notification type
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In the majority of the cases, the drop down menu will propose 3 options, i.e. 'predefined frame formulations', 'exact concentrations' or 'concentration ranges'.
The symbol reminds the responsible persons that all ingredients names shall be expressed using INCI names, when available, and that all ingredients quantities shall be expressed using % w/w
In some cases, depending on the categories of cosmetic products selected, there may be no existing predefined frame formulation. In these cases, the CPNP will only propose two options, i.e. 'exact concentrations' or 'concentration ranges'.
Important notice
Upon specific and individual request, whatever is the notification type chosen by a responsible person for the notification of a cosmetic product pursuant Article 13(1) of Regulation (EC) No 1223/2009, additional information should be provided to poison centres or similar bodies, where such centres or bodies have been established by Member States, to allow prompt and appropriate treatment in the event of difficulties.
II.2.2.2.5.1 Predefined frame formulation A set of predefined frame formulations have been elaborated by an expert group composed of representatives from poison centres, competent authorities, industry trade associations and Commission’ services and are available for consultation in the Annex II to this User Manual. These frame formulations will be regularly updated in light of technical and scientific progress, in accordance with Article 2(s) of Regulation (EC) No 1223/2009. If the responsible person selects 'predefined frame formulation', the CPNP will automatically propose the corresponding predefined frame formulation on the basis of the category and formulation name selected by the responsible person. This predefined frame formulation will be linked to the notification as a PDF document. This PDF document can be opened by the responsible person in order to check its relevance for the product being notified by clicking on .
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Important notice
The term 'additional ingredient' used in some predefined frame formulations cannot cover any ingredient falling under any of the rules set out in the Annex I to this User Manual and/or any ingredient that would contribute in a significant way to the toxicity
profile of the cosmetic product.
Important notice
A notification via predefined frame formulation can be done only if the composition of the cosmetic product completely falls within the
concentration ranges mentioned in this frame formulation.
In particular, if any ingredient concentration is higher than the maximum levels indicated in the predefined frame formulation, or if any ingredient is not covered by the predefined
frame formulation content, this predefined frame formulation must not be used for the notification.
Specific information for Poison Centres regarding hair colouring products
90% of total hair color market consists of permanent hair coloring products based on oxidative dyes. Permanent hair coloring products are typically two component products which are mixed by the consumer immediately before application to the hair; they are typically left on the hair for 30minutes before rinsing and drying of the hair. − Component 1 is usually labelled “color cream” or “color gel” and is usually an off-white
or yellow-orange cream or liquid containing the oxidative dyes and the alkali (ammonia or mono-ethanolamine).
− Component 2 is usually labelled developer cream or lotion and is a white liquid containing the oxidant (hydrogen peroxide).
Oxidative dyes themselves are small colorless molecules which diffuse into the hair together with hydrogen peroxide whereupon they start to couple with each other to form
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larger colored molecules inside of the hair (see SCCS opinion on reaction products in oxidative products 1311/10) Oxidative dyes can be split into two groups: − Primary Intermediates or Precursors such as p-phenylenediamines and p-
aminophenols. − Couplers or Color Modifiers such as resorcinols and m-aminophenols. The types of precursors and couplers found in commercial products in the EU are relatively limited. − There are three classes of Oxidative Primary intemediates. By far the most commonly
used are the p-phenylenediamines (e.g. p-phenylenediamine, p-toluenediamine) and p-aminophenols.
− There are five classes of Oxidative Couplers. The most commonly used are resorcinols, m-aminophenols and m-phenylenediamines
Concentrations in precursors and couplers vary depending on the shades and the way they are formulated. It is worth mentioning that concentrations are often restricted and the maximum level allowed are available in the annexes of the Directive (or via the CosIng database).
Some permanent hair coloring products combine oxidative dyes with a limited number of direct dyes. The direct dyes are small phenylenediamines and phenols substituted with a nitro group (see examples below)
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Depending on the product categories, the physical form and the formulation name selected, additional information will be asked by the CPNP on specific ingredients of concern and/or the pH value of the product. The rules that the CPNP applies have been elaborated by an expert group composed of representatives from poison centres, competent authorities, industry trade associations and Commission’ services and are available for consultation in the Annex I to this User Manual. The following first question will be asked:
Please carefully go through the whole list of ingredients by clicking on each of the symbols.
The responsible person has either to click on 'Yes, see below', check the box of the relevant ingredient(s) and indicate its (their) concentration(s) in the product, or to click on 'No'. For the other questions, the responsible person will usually have two choices, i.e. to answer the question in the dedicated fields or answer 'not applicable'.
To facilitate the entry of names of ingredients, a link is made to CosIng to retrieve the information. The responsible person can also type an ingredient name if the name is not included in CosIng.
Important notice
'Not applicable' means in the case of ethanol and/or isopropanol that these ingredients are not present in the product!
'Not applicable' means in the case of all other ingredient of concern that the
ingredient is either not present in the product, or is present in the product but under the concentration of concern (according to the rules set out in the
Annex I to this User Manual).
All ingredient names shall be expressed using INCI names, when available.
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Where the information on pH is required and the pH could not be measured in the product
directly, but through an aqueous solution, extract or dispersion (e.g. for solid formulations), the user should mention this in the field dedicated to "Any other information
of significance for poison centres" using the expression "pH (aqueous extract/solution/dispersion)" in English only.
All ingredient quantities shall be expressed using % w/w. The symbol % w/w shall
not be indicated in the answering field.
The CPNP applies the English notation for numbers Example: 0.3 and not 0,3
For ethanol and/or isopropanol, an updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5, if the value declared previously is <30%, or by more than 10, if
the value declared previously is ≥ 30%
For all other ingredients of concern, an updated notification is required when the concentration of the ingredient changes by more than 20% of the
value previously declared (see Annex I to this User Manual for further details).
An updated notification is also required when the product does not fall anymore in the predefined frame formulation, when a new ingredient of
concern enters in the composition of the product or when an ingredient of concern no longer enters the composition of the product.
II.2.2.2.5.2 Exact concentration declaration If the responsible person selects 'Exact concentration', the CPNP will ask whether he wants to upload a file for the qualitative and quantitative composition.
1/ If the responsible person answers 'yes', he is asked to attach the corresponding file. Only PDF format is allowed.
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Important notice
No hand-written document is allowed. Only clear and legible electronic PDF text format documents are allowed.
In order to facilitate poison centres reading in emergency situations, it is recommended that the exact concentration document starts by mentioning the ingredients of
concerns and their concentration (according to the rules set out in Annex I to this User Manual) and then lists all other ingredients by decreasing order of
their concentration in the product.
All ingredient names shall be expressed using INCI names, when available.
All ingredient quantities shall be expressed using % w/w. The symbol % w/w shall not be indicated in the answering field.
The CPNP applies the English notation for numbers Example: 0.3 and not 0,3
Where the information on pH is required and the pH could not be measured in the product
directly, but through an aqueous solution, extract or dispersion (e.g. for solid formulations), the user should mention this in the field dedicated to "Any other information
of significance for poison centres" using the expression "pH (aqueous extract/solution/dispersion)" in English only.
For ethanol and/or isopropanol, an updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5, if the value declared previously is <30%, or by more than 10, if
the value declared previously is ≥ 30%
For the other ingredients, an updated notification is required when the concentration of an ingredient changes by more than 20% of the value
declared previously, when a new ingredient enters in the composition of the product or when an ingredient no longer enters the composition of the product.
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2/ If the responsible person answers 'no', it is asked to enter the ingredients one by one. To facilitate the entry of names of ingredients, a link is made to CosIng to retrieve the information. The responsible person can also type an ingredient if its name is not included in CosIng. Here too, it is recommended that the responsible person starts by mentioning the ingredients of concern, and their concentration (according to the rules set out in Annex I to this User Manual) and then lists all other ingredients by decreasing order of concentration in the product. The responsible person should also mention in the dedicated field any other information on the product that would be of significance for poison centres (using English only).
Depending on the product categories and formulation name selected, additional information may be asked by the CPNP on the pH value.
II.2.2.2.5.3 Concentration ranges declaration If the responsible person selects 'Concentration ranges', the CPNP will ask whether he wants to upload a file for the qualitative and quantitative composition. 1/ If the responsible person answers 'yes', it is asked to attach the corresponding file. Only PDF format is allowed.
Important notice
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No hand-written document is allowed. Only clear and legible electronic PDF text format documents are allowed.
For ingredients that are not of special concern only the following concentration
ranges are allowed:
[0% - 0.1%] ]0.1% - 1%] ]1% - 5%] ]5% - 10%]
]10% - 25%] ]25% - 50%] ]50% - 75%]
]75% - 100%]
In order to facilitate poison centres reading in emergency situations it is recommended that the concentration ranges document starts by mentioning the ingredients of
concerns and their exact concentration (according to the rules set out in the annex to this User Manual) and then lists all other ingredients by decreasing
order of their concentration range in the product.
Where the information on pH is required and the pH could not be measured in the product directly, but through an aqueous solution, extract or dispersion (e.g. for solid
formulations), the user should mention this in the field dedicated to "Any other information of significance for poison centres" using the expression "pH (aqueous
extract/solution/dispersion)" in English only.
For ethanol and/or isopropanol, an updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5, if the value declared previously is <30%, or by more than 10, if
the value declared previously is ≥ 30%
For all other ingredients of concern, an updated notification is required when the concentration of an ingredient changes by more than 20% of the
value previously declared (see Annex I to this User Manual for further details).
An updated notification is also required when an ingredient falls in a concentration range different from the one previously declared, when a new ingredient of concern enters in the composition of the product or when an
ingredient of concern no longer enters the composition of the product.
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As for predefined frame formulations, depending on the product categories, the physical form and the formulation name selected, additional information will be asked by the CPNP on specific ingredients of concern and/or the pH value of the product. The rules that the CPNP applies have been elaborated by an expert group composed of representatives from poison centres, competent authorities, industry trade associations and Commission’ services and are available for consultation in the Annex I to this User Manual. The following first question will be asked:
Please carefully go through the whole list of ingredients by clicking on each of the symbols.
The responsible person has either to click on 'Yes, see below', check the box of the relevant ingredient(s) and indicate its (their) concentration(s) in the product, on 'Yes, see attachment' if the answer is provided in the attachment or on 'No' if the product contains none of the ingredients listed. For the other questions, the responsible person will usually have three options, i.e. to answer the question in the dedicated fields, answer 'not applicable' or answer 'see attachment'.
Important notice
'Not applicable' means in the case of ethanol and/or isopropanol that these ingredients are not present in the product!
'Not applicable' means in the case of all other ingredients of concern that the
ingredient is either not present in the product, or is present in the product but under the concentration of concern (according to the rules set out in the
Annex I to this User Manual).
'See attachment' can be used to answer a specific question only when the information requested on the ingredient of concern is provided in the
qualitative and quantitative composition document attached.
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All ingredient names shall be expressed using INCI names, when available.
The quantities of all the ingredients of concerns shall be expressed using % w/w. The
symbol % w/w shall not be indicated in the answering field
The CPNP applies the English notation for numbers Example: 0.3 and not 0,3
2/ If the responsible person answers 'no', it is asked to enter the ingredients and the corresponding concentration ranges one by one by decreasing order of concentration in the product. To facilitate the entry of names of ingredients, a link is made to CosIng to retrieve the information. The responsible person can also type an ingredient if the name is not included in CosIng.
The responsible person should also mention in the dedicated field any other information on the product that would be of significance for poison centres (using English only).
II.2.2.3 Section Original labelling & original packaging In this section, the responsible person has to attach the original labelling and a photograph of the original packaging (where reasonably legible). Only PDF, JPG or JPEG format are accepted. 'Original' means the one corresponding to the first placing on the market in the EU.
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The submission of the original labelling and of a photograph of the original packaging (where reasonably legible) is mandatory at the latest when the product is placed on the market. Various situations may occur:
Example 1: a single component product without any secondary packaging (e.g. a standalone bottle of shampoo)
→ The original labelling of the bottle and, if reasonably legible, the photograph of the bottle shall be submitted.
Example 2: a single component product with a secondary packaging (e.g. a bottle of shampoo in a box)
→ The original labelling of the box (outer packaging) and, if reasonably legible, the photograph of the box shall be submitted.
→ Optionally, the original labelling and the photograph of the bottle can also be submitted.
Example 3: a multi-component product (e.g. a set composed of three bottles)
→ The original labelling of the set and, if reasonably legible, the photograph of the set shall be submitted.
→ Optionally, the original labelling of each bottle and the photograph of each bottle can also be added to the notification at the component level.
Important notice
The labelling shall include any text, symbols, pictures etc (e.g. art work). It shall cover notably all the mandatory elements mentioned in Article 19 of Regulation (EC)
N°1223/2009. In cases where, in accordance with Article 19(2), some mandatory information is mentioned on an enclosed or attached leaflet, label, tag or card,
this leaflet, label, tag or card shall also be included in the notification.
If the notification covers several pack sizes or shades, the most legible original labelling & original packaging are to be attached to the notification, usually the biggest pack size.
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To add an image of the original labelling or a photograph of the original packaging the
responsible person has to click on . A pop up will appear where the documents can be uploaded.
The responsible person has then to click on to attach the document to the
notification or on
The button gives the possibility to add more than one document.
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The responsible person can view the documents it has attached by clicking the view button or delete them by clicking in the delete button
Important notice
The size of all attached documents (labelling, photograph of the packaging, composition document) cannot exceed 2 MB.
Important notice The labelling can also be submitted by using the free text box. This is however limited to
the very specific cases where the labelling is exclusively composed of text.
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II.3 NOTIFICATIONS PURSUANT TO ARTICLE 13(1) and (2) - MULTI-COMPONENT PRODUCT A notification that relates to products composed of several components (e.g. hair dye sets, make-up sets) that are not marketed separately will be different from that of a single component product. Note: Sets do not need to be notified as multi-component products provided that all components that compose this set have been notified individually. To create a notification for a multi-component product the responsible person has to click on ‘Notify a multi-component product' in the ‘Products’ tab.
The general form for the notification of that multi-component product will be displayed. Three different tabs are available, one titled ‘General information’ and two titled ‘Component’:
The ‘General information’ tab allows the responsible person to enter some general information about the product (e.g. kit, set, etc) (see section II.2.1 for further details). Additional question on pH will be asked by the CPNP. In particular, the CPNP will ask if the components of the products are intended to be mixed.
If the responsible person answers 'yes' the CPNP will ask if the produc is a hair dye.
If the responsible person answers 'No' the CPNP will ask if the pH is lower than 3 or higher than 10.
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If the responible person answers 'Yes' the CPNP will ask to indicte the pH range. The pH range cannot exceed 1 pH unit.
If the responsible person indicates that the product is a hair dye, the CPNP will directly ask the pH range. The pH range cannot exceed 1 pH unit.
The 'Component' tabs will allow the responsible person to enter the information on each of the components separately (see section II.2.2 for further details).
Important notice
The component name is a crucial element of the notification as it might be used by competent authorities or by poison centres to search for a specific component in the database.
The component name must be detailed enough to enable its specific identification.
Only in cases where the component has no name (e.g. certain make-up set components) the
component name shall be understood as the description of the component that enables its specific identification.
By default two component tabs are displayed, but additional component tab(s) can be added to
the notification by clicking on . The user can:
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: The notification is saved as draft but not notified. A notification can be saved as draft without all the required fields being filled. To save a notification as draft, at least a product/component name and the corresponding language must be filled (indicated by a "**").
: The notification is complete and will be made available to poison centres and competent authorities. It will then be not possible to delete this notification from the system. Only update or correction will be possible. A notification can be notified only when all mandatory fields indicated by a "*" are filled in. If some mandatory information is missing, the system will not accept the notification and will display a warning message indicating how many fields are missing. The system will indicate the tab(s) where the information is missing and will show the message 'this field is required' next to the field(s) that still needs to be filled in.
: The ongoing operation is aborted.
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II.4 NOTIFICATIONS PURSUANT ARTICLE 13(3) - DISTRIBUTION A distributor who makes available in a Member State a cosmetic product already marketed in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law must notify some information in the CPNP. To enter a distribution notification the distributor has to select 'notify a product' in the 'Distributors' tab.
Step 1 - The CPNP will first ask the distributor to provide the name of the responsible person of the product that the distibutor wants to distribute.
Step 2 - On the basis of the information entered by the distributor, the CPNP will display a limited list of result of matching responsible person names. The distributor has to select one of the proposed results. The system will then display (in read-only mode) the address associated to this responsible person. Step 3 - The CPNP will then ask the distributor to enter the product name in the Member State of dispatch. On the basis of the information entered by the distributor, the CPNP will display a limited list of result of product names matching. The distributor has to select one of the proposed results.
Step 4 - The CPNP will display (in read only mode) the category of the cosmetic product associated to this product in the CPNP. Step 5 - The CPNP will ask the distributor to select in the drop down menu the Member State in which he makes the product available.
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The distributor has to enter the product name in the Member States in which the distibutor makes the product available and to select the corresponding language in the drop down menu.
Step 6 – If the product is a multi-component product, the distributor has to enter the component name in the Member States in which the distributor makes the product available and to select the corresponding language in the drop down menu.
Three buttons are available at the bottom right of the screen. If the distributor wants to save the notification as draft, the distributor has to click on
.
If the distributor wants to abort the ongoing operation, the distributor has to click on . When the information on the distribution notification is complete the distributor can click on
. The information will be made available to competent authorities and poison centres. It will be linked to the original notification of the product being distributed. It will then be not possible to delete this notification from the system. Only update will be possible.
II.5 SEARCH TOOLS
II.5.1 Simple search The 'Simple search' is intended for the responsible persons, the competent authorities and the poison centres. It allows these users to quickly search for a notification in the database, using key words. To reduce the amount of data returned at least three characters must be entered.
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The data that is accessible though the simple search depends on the user profile: - A responsible person can search only for the notifications it (or users acting on its behalf) has entered into the system. A responsible person that has given access to several users to act on his behalf can see all notifications entered by these users. A responsible person can search for draft and submitted notifications. - Competent authorities and poison centres can search for all submitted notifications contained in the system. Draft notifications are not accessible to competent authorities and poison centres. The 'Simple search' searches on product name, component name, responsible person name, distributor name (for competent authorities and poison centres only), category (level 3), formulation name (for responsible person and poison centres only) and CPNP reference.
As shown above, the keyword(s) used for the simple search will be highlighted in the list of results.
II.5.2 Advanced search The 'Advanced search' is intended for the responsible persons, the competent authorities and the poison centres. It allows these users to search a product into the CPNP using cumulative search criteria. The advanced search criteria are spread over two different tabs.
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The tab allows the users to search on the following general information criteria about the product:
The tab allows the users to search on the following criteria related to the category and the formulation of the product.
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At the bottom right of the screen the buttons and allow either to reset the search criteria or to launch the search based on the criteria that have been filled in. There are two icons at the top right of the results screen and . They allow exporting the results list in a PDF or XLS format.
II.5.3 Distribution search The 'Distribution search' is intended for the distributors only. It allows a distributor to search for its notifications.
This search tool allows the distributor to search on the product name in the Member State where the distributor has made the product available, on the Member State where the product was made available by the distributor and on the status of the notification (i.e. draft or notified).
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The two following buttons are available at the bottom right of the screen.
to reset the search criteria.
to launch the search.
II.5.4 Responsible person search The 'Responsible person search' is intended for the competent authorities and poison centres only. It allows these users to search for a responsible person in the CPNP, by its name, the postal code or the country of its address. It then allows for the consultation of all notifications of this responsible person.
II.6 VIEW, EDIT or DUPLICATE NOTIFICATIONS PURSUANT ARTICLE 13(1) and (2) Once a simple search or an advanced search has been performed, the CPNP will display the list of results.
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To shorten the list of results the 'Search' filter tool can be used on the top right of the results list. A possibility to see more results on the same page is available by using the drop down menu and selecting 'Show 10 – 25 – 50 or 100 entries' on one page. II.6.1 - View product The accessible information depends on the user profile: The responsible person and the poison centres can see all the information contained in the notification. The competent authorities do not have access to information related to the formulation name, frame formulation number and qualitative and quantitative composition information, except the information concerning the presence of CMR substances of category 1A or 1B and of substances in the form of nanomaterials. In the results list, the symbol may appear in the column 'product name' for some notifications. It means that the original labelling (and the photograph of the packaging, if reasonably legible) of the product have not yet been notified and indicates therefore that the product is not yet placed on the market. After having clicked on a header is available for consultation:
The header allows the direct consultation of some important information on the product: - the product name; - the product name in the interface language; - the responsible person name; - the CPNP reference i.e. the reference given by the CPNP to the product; - the current version number (indicating the formula version, not the dataset version, see below); - the date of the first notification;
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- the access to the previous versions.
II.6.1.1 Single-component products
The 'General information' tab displays some general information on the product, e.g.: - the CPNP reference; - the industry reference (only for industry's internal use); - the version of the notification; - the last modification date and time stamp; - the product name(s), shades (if applicable) and corresponding language(s), given by the responsible person and by the distributors; - the information on whether the product is specifically intended for children under 3 years of age; - the responsible person details (at least name and address); - the contact person details; - the information on whether the product is ready to go on the market or already on the market; - if the product imported in the Community (and if so, the country of origin); - the Member State of first placing on the market. The 'Product details' tab displays information on: - the category of the product; - the physical form of the product; - the special applicator or packaging (if applicable); - information on the pH of the product (if applicable); - the notification type (i.e. predefined frame formulations, exact concentrations or concentration ranges); - the information on ingredients of concern contained in the product (name and quantity % w/w). Note: Where 'not applicable' is indicated, the meaning is indicated in the right column, i.e. either it means that the ingredient is 'not present' in the product (in this case 0% w/w is indicated) or is present in the product but under the concentration of concern (in this case the concentration of concern is indicated); - the formulation name (and formulation number in case of predefined frame formulation);
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- an hyperlink to the composition of the product (predefined frame formulation, exact composition or composition with ranges); - information on CMR substances of category 1A or 1B present in the product; - information on substances in the form of nanomaterials present in the product; - any other information of significance for poison centres; - the original packaging of the product (accessible by clicking on ); - the original labelling of the product (accessible by clicking on ); - the original labeling of the product (text only). The 'Previous version(s)' tab indicates into brackets the number of versions and displays information on these different versions of the notification (period of validity, type of change (update or correction) and reason for change (see section II.6.2). The 'Distributed' tab is only available to competent authorities and poison centres. This tab shows the contact details of the distributors.
At the bottom right up to four buttons may appear
The button allows the user to create a PDF document for the notification.
The button allows the user to export the notification, using XML files. The button is only available for responsible persons. It allows the responsible person to edit its notification.
The button allows the user to go back to the search screen.
II.6.1.2 Multi-component products
For the multi-component products the tabs available are slightly different. The 'General information' tab displays some general information on the product, e.g.: - the CPNP reference i.e. the reference given by the CPNP to the product; - the industry reference i.e. the reference given by the industry to the product (only for industry internal use); - the version of the notification;
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- the last modification date and time stamp; - the product name(s), shades (if applicable) and corresponding language(s), given by the responsible person and by the distributors; - the information on whether the product is specifically intended for children under 3 years of age; - the responsible person details (at least name and address); - the contact person details; - the information on whether the product is ready to go on the market or already on the market; - if the product imported in the Community (and if yes, the country of origin); - the Member State of first placing on the market; - the pH of the mixed product (if appropriate) - the original packaging of the product (accessible by clicking on ); - the original labelling of the product (accessible by clicking on ); - the original labeling of the product (text only) Each 'Component' tab(s) display(s) information on: - the component name(s), shades (if applicable) and corresponding language(s), given by the responsible person and by the distributors, if any; - the category of the component; - the physical form of the component; - the special applicator or packaging (if applicable); - the notification type (i.e. predefined frame formulations, exact concentrations or concentration ranges); - the information on ingredients of concern contained in the component (name and quantity % w/w). Note: Where 'not applicable' is indicated, the meaning is indicated in the right column, i.e. either it means that the ingredient is 'not present' in the product (in this case 0% w/w is indicated) or is present in the product but under the concentration of concern (in this case the concentration of concern is indicated); - an hyperlink to the composition of the component (predefined frame formulation, exact composition or composition with ranges); - the formulation name of the component; - information on CMR substances of category 1A or 1B present in the component; - information on substances in the form of nanomaterials present in the component; - other information of significance por poison centres; - optionally, the original packaging of the component(accessible by clicking on ); - optionally, the original labelling of the component (accessible by clicking on ); - optionally, the original labeling of the component (text only)
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The 'Previous version(s)' tab indicates into brackets the number of versions and displays information on these different versions of the notification (dates of validity, type of change (update or correction) and reason for change (see section II.6.2). The 'Distributed' tab is only available to competent authorities and poison centres. This tab shows the contact details of the distributors.
At the bottom right up to four buttons may appear
The button allows the user to create a PDF document for the notification.
The button allows the user to export the notification, using XML files. The button is only available for responsible persons. It allows the responsible person to edit its notification.
The button allows the user to go back to the search screen. II.6.2 - Edit product The 'Edit product' function is only available for the responsible person. It allows the responsible person to edit a notification it has previously entered in the system.
Important Notice
Where any of the information set out in paragraphs 1, 3 and 4 of Article 13 of Regulation 1223/2009 changes, the responsible person or the distributor shall update its notification without
delay.
Once the change(s) made, the system will ask the responsible person for the modification type (update or correction) and the modified items.
Important Notice
It is important to make a clear distinction between an update and a correction. It is particularly important to make this distinction when it concerns the formulation. An ‘update’ of the formulation means a change of previously valid information. The original data are related to the older product formulation while the updated dataset relates to the new
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formulation. Poisons centre must evaluate both formulations in case they cannot reliably decide which formulation version is involved in an exposure case. A ‘correction’ of the formulation means change of erroneous or incomplete product information without changing the (real world) formula. Poisons centre need only evaluate the corrected dataset.
The responsible person has the possibility to add a comment (using English only) in the free text box should it wish to provide further details on the modification.
Once the information has been entered, the responsible person has to click on to notify the change in the system. This change will be made available to competent authorities and poison centres.
Important notice
Only an update (not a correction) of the formulation and/or category will create a new version of the notification. All other changes will result into a new time stamp of the same version of the notification.
Should the responsible persons want to cancel the modification it has to click on . II.6.3 - Duplicate a product
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This function allows the responsible person to duplicate an existing notification. This is a useful function when very similar products have to be notified separately since it avoids retyping all identical information. The system duplicates all data except the answers to ingredient of concern specific questions, attached labelling (and packaging where appropriate) and the checkbox 'Product ready to go on the market or already on the market'.
II.7 VIEW AND EDIT NOTIFICATIONS PURSUANT ARTICLE 13(3) Once a search for notifications pursuant Article 13(3) has been performed, the following screen will be displayed:
If the distributor wants to update or correct one of the displayed notifications, he has to click on
. The CPNP will then display the notification screen and the distributor can update or correct the information that was submitted.
Two buttons are available, to notify the change / correction or to cancel the operation.
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ANNEX I: Rules on specific ingredients of concern and/or the pH value Rule 1 Ethanol and/or isopropanol The percentage weights (w/w) of ethanol and/or isopropanol must be specified for all products. An updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than:
- 5 if the value declared previously is < 30% Examples: A change from 20% of ethanol to 26% ethanol constitutes a change of 6 in the ethanol content in the formulation and therefore requires an updated notification. A change from 20% of ethanol and 20% isopropanol to 23 % of ethanol and 24 % of isopropanol constitutes a change of 7 of the sum of ethanol and isopropanol in the formulation and therefore requires an updated notification. - 10 if the value declared previously is ≥ 30% If ethanol or isopropanol are not present in the cosmetic product, then 'not applicable' must be checked. Note: declarations of percentage weights may be rounded to the nearest whole number. Note: if the percentage weight is below 1%, it can be specified as 1%.
Rule 2 Antidandruff products The INCI name and the concentration of the antidandruff agent(s) must be specified. An updated notification is required when the concentration of the antidandruff agent changes by more than 20% of the value declared previously.
Rule 3 Anti-hair loss products The INCI name and the concentration of the anti-hair loss agent(s) must be specified. An updated notification is required when the concentration of the anti-hair loss agent changes by more than 20% of the value declared previously.
The INCI name and the concentration of anti-pigmenting and depigmenting agent(s) must be specified. An updated notification is required when the concentration of at least one agent changes by more than 20% of the value declared previously. If anti-pigmenting and depigmenting agent(s) are not present in the cosmetic product, then 'not applicable' must be checked.
Rule 5 Chemical exfoliation products containing chemical exfoliating
agent(s) (e.g. lactic acid, glycolic acid, salicylic acid) The INCI name and the concentration of chemical exfoliating agent(s) must be specified. An updated notification is required when the concentration changes by more than 20% of the value declared previously.
Rule 6 Products containing vitamin A and derivatives (e.g. retinol, retinyl esters)
The exact content of vitamin A or any of its derivatives must be specified if the level exceeds 0.20 % (calculated as retinol) or if the amount exceeds 0.09 grams (calculated as retinol) for the whole product. An updated notification is required when the concentration of vitamin A or derivatives changes by more than 20% of the value declared previously. If the level of vitamin A or any of its derivatives does not exceed 0.20% (calculated as retinol) or if the amount does not exceed 0.09 grams (calculated as retinol) or if vitamin A or any of its derivatives are not present in the product, then 'not applicable' must be checked.
Should a product contain more than 0.5% xanthine derivatives, the INCI name and the concentration of the derivative(s) must be specified. An updated notification is required when the concentration changes by more than 20% of the value declared previously. If xanthine derivatives are not present or present below 0.5% in the cosmetic product, then 'not applicable' must be checked.
Rule 8 Products containing cationic surfactants with two or more chain lengths below C12
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The INCI name and the concentration of cationic surfactants with two or more chain lengths below C12 must be specified if the surfactant is used for non preservative purpose. An updated notification is required when the concentration changes by more than 20% of the value declared previously. Typical examples for cationic surfactants covered by this rule: • behentrimonium chloride • distearyldimonium chloride • cetrimonium chloride • dicetyldimonium chloride If cationic surfactants with two or more chain lengths below C12 are not present in the product, then 'not applicable' must be checked. Rule 9 Products containing propellants The INCI name and the concentration of each propellant must be specified. An updated notification is required when either of these concentrations changes by more than 20% of the value declared previously. If propellants are not present in the product, then 'not applicable' must be checked. This rule concerns aerosol spray products and any other product which are presented in aerosol spray.
Rule 10 Products containing or releasing hydrogen peroxide The concentration of hydrogen peroxide and/or the INCI name and concentration of the compounds releasing hydrogen peroxide must be specified. An updated notification is required when the concentration changes by more than 20% of the value declared previously. If hydrogen peroxide and compounds releasing hydrogen peroxide are not present in the product, then 'not applicable' must be checked. This rule concerns hair colorant products, hair bleach products, permanent wave products, and hair straighteners.
Rule 11 Products containing reducing agents The INCI name and the concentration of each reducing agent must be specified. An updated notification is required when either of these concentrations changes by more than 20% of the value declared previously. This rule concerns depilatories, hair dyes, dye removers and permanent wave products.
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Examples for reducing agents typically used are:
• thioglycerin, • thioglycolic acid and its salts (ammonium thioglycolate, ethanolamine thioglycolate) • ammonium thiolactate • cysteine HCl • sodium sulfite • sodium metabisulfite • sodium hydroxymethane sulfonate • sodium hydrosulfite • alkaline and earth alkaline sulphides If reducing agent(s) are not present in the product, then 'not applicable' must be checked.
Rule 12 Products containing persulfates The INCI name and the concentration of each persulfate must be specified. An updated notification is required when either of these concentrations changes by more than 20% of the value declared previously. If persulfate(s) are not present in the product, then 'not applicable' must be checked.
Rule 13 Products containing hair straightening agents The INCI name and the concentration of straightening agents must be specified. An updated notification is required when either of these concentrations changes by more than 20% of the value declared previously. Examples for straightening agents typically used are:
• sodium hydroxide, potassium hydroxide, lithium hydroxide • potassium citrate • calcium hydroxide • guanidine carbonate • reducing agents : o ammonium thioglycolate o ammonium thiolactate o cysteine HCl o ethanolamine thioglycolate
Rule 14 Bath salts/cubes containing inorganic sodium salts The total concentration of sodium salts must be specified. An updated notification is required when the total concentration of inorganic sodium salts changes by more than 20% of the value declared previously.
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Rule 15 Toothpastes and Mouthwashes containing Fluoride compounds The concentration of fluoride compounds (calculated as Fluorine), must be specified. An updated notification is required when the fluorine concentration changes by more than 20% of the value declared previously. If fluoride compounds are not present in the product, then 'not applicable' must be checked.
Rule 16 Products with a pH lower than 3 or higher than 10, and pH of hair coloring products
The pH of single-component products or individual component (except for hair dyes)
must be specified in the pH field if it is lower than 3 or higher than 10.
In the case of multiple component products (except for hair dyes) that are mixed prior to use, the pH of the mixed product must be specified in the respective pH field if it is lower than 3 or higher than 10. It is acknowledged that different mixing ratios of components (e.g. to achieve different strengths) can lead to pH variations. In case the exact pH cannot be determined for the mixed product then the pH can be expressed in range form of no more than one unit (e.g. 9.5 – 10.5).
For the case of single-component or multi-component hair dyes, the pH must always be indicated, even if it is within the range of pH 3 to pH 10.
However given pH variations between color shades of the same product, the indication of an exact pH may not be relevant. For these products, the pH of the components and the mixed products can be expressed in range form of no more than one unit (e.g. 8.5 – 9.5)
In all cases above, an updated notification is required when the pH declared previously changes by more than 0.5.
For any product or component with a pH higher than 10, the INCI name and concentration of each alkaline agent, and – if applicable – ammonium hydroxide liberator must be specified.
An updated notification is required when either of these concentrations changes by more than 20% of the value declared previously
• ethanolamine A typical ammonium hydroxide liberator is
• ammonium chloride
Rule 17 Products containing essential oils, camphor, menthol or eucalyptol Except for perfume and some limited other product categories, when a manufacturer introduces in a formula essential oils, camphor, menthol or eucalyptol with a total level higher than 0.5%, the total level concentration must be indicated. If essential oils, camphor, menthol or eucalyptol are not present in the product or if the total level of essential oils, camphor, menthol and eucalyptol does not exceed 0.5%, then 'not applicable' must be checked. For each individual essential oil and camphor, menthol or eucalyptol with a level higher than 0.5% (0.15 % in case of camphor), the manufacturer must state the name and quantity of this essential oil/essential oil derivative. If no individual essential oil, camphor, menthol or eucalyptol are present with a level higher than 0.5% (0.15 % in case of camphor), then 'not applicable' must be checked. An updated notification is required when the concentration changes by more than 20% of the value declared previously.
Rule 18 Other Ingredients In addition to the rules above, a number of substances have been identified by European Poison Control Centres as posing a particular concern with regard to an acute poisoning emergency. The concentration, above the indicated threshold, of any of these ingredients in a formulation must be specified. If no threshold is indicated, the concentration must always be specified. An updated notification is required when the concentration changes by more than 20% of the value declared previously: Glycols and Glycol ethers BUTETH-2 ACETATE (above 1%) BUTOXYDIGLYCOL (above 1%) BUTOXYETHANOL (above 1%) BUTOXYETHYL ACETATE (above 1%) DIETHOXYDIGLYCOL (above 1%) DIPROPYLENE GLYCOL (above 10%) DIPROPYLENE GLYCOL DIMETHYL ETHER (above 10%) DIPROPYLENE GLYCOL ISOBORNYL ETHER (above 10%)
MIBK (above 5%) POTASSIUM CHLORATE (above 0,1%) SODIUM CHLORATE (above 0,1%) TRIETHYL PHOSPHATE (above 0,1%) The user should also notify in the dedicated field any other information on the product that would be of significance for poison centres or similar bodies, where such centres or bodies have been established by Member States (using English only). Note : Frame formulations mentioning “AQUA” also cover products in which water is not added as such as an ingredient but through carry-over from aqueous plant extracts, fruit juices, etc
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ANNEX II: Frame formulations
1. SKIN CARE
SKIN CARE CREAM, LOTION, GEL 1.1
SKIN CARE CREAM, LOTION, GEL - WITH HIGH LEVEL OF SILICONES 1.2
SKIN CARE CREAM, LOTION, GEL - WITH HIGH LEVEL OF HUMECTANTS 1.3
SKIN CARE CREAM, LOTION, GEL - WITH HIGH LEVEL OF BULKING AGENTS 1.4
SKIN CARE CREAM, LOTION, GEL - WITH HIGH LEVEL OF FATTY COMPOUNDS 1.5
SKIN CARE CREAM, LOTION, GEL - WITH HIGH LEVEL OF UV FILTERS 1.6
SKIN CARE CREAM, LOTION, GEL – WITH HIGH LEVEL OF PERFUME 1.7
ZINC OXIDE BASED CREAM 1.8
SKIN GEL (HYDRO-ALCOHOLIC BASED) 1.9
SKIN OIL 1.10
TONIC, COSMETIC WATER 1.12
CHEMICAL EXFOLIATION PRODUCTS 1.13
SKIN CARE (SILICONE BASED) 1.14
PETROLEUM JELLY 1.15
TALCUM POWDER (LOOSE OR PRESSED) 1.16
LIP CARE (STICK, CREAM, GEL) 1.17
2. SKIN CLEANSING
FOAMING SKIN CLEANSER1 2.1
FOAMING SKIN CLEANSER – WITH HIGH LEVEL OF OILS AND/OR HUMECTANT 2.2
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MAKE-UP REMOVER - NON FOAMING CLEANSER (INCLUDING TWO-PHASE PRODUCTS) 2.3
To be mixed immediately prior to use with oxidative part (11.8-2011 or 11.9-2011) Ingredients Maximum levels (% w/w) Anionic surfactants (e.g. ammonium laureth sulfate) 20 Non-ionic surfactants (e.g. laureth-12, deceth-3) 20 Amphoteric surfactants (e.g. betaine derivatives) 20 Emulsifying agents (e.g. ethoxylated long chain alcohols) 30 Soaps (e.g. ammonium hydroxide/ethanolamine oleates) 30 Solvents (e.g. propylene glycol, glycerin) 20 Thickeners (e.g. carbomer, long chain alcohols) 20 Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) 16 Hair dyeing agents: Primary intermediates (e.g. p-phenylenediamines such as p-phenylenediamine and toluene-2,5-diamine, p-aminophenols such as p-aminophenol and 4-amino-m-cresol, heterocyclic diamines such as 1-hydroxyethyl 4,5-diamino pyrazole sulfate) 6 Couplers (e.g. m-aminophenols such as m-aminophenol and 4-amino-2-hydroxytoluene, m-phenylenediamines such as 2-amino-4-hydroxyethylamino-anisole, resorcinols such as resorcinol and 4-chlororesorcinol, pyridines such as 2,6-dihydroxy-3,4-dimethylpyridine, naphtols such as 1 ,5-naphthalenediol) 6 Directs (e.g. HC red no. 3, 2-amino-6-chloro-4-nitrophenol, basic yellow 87) 6 Alkaline agents (e.g. ammonium hydroxide*, ethanolamine) 10 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine) 5 Cationic polymers (e.g. polyquaternium-6) 5 Additional ingredients (e.g. hair conditioning agents, pearlescent agents) 5
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Antioxidants, reducing agents (e.g. ascorbic acid, sodium metabisulfite) 3 Parfum 2 Chelating agents (e.g. EDTA) 1 Aqua to 100 pH value: 8 - 11.6 pH value of the mixture with oxidative part: 8 - 11.6 * maximum concentration of ammonium hydroxide permitted is 6 %
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Frame formulation Number: 11.5 - 2011
HAIR COLORANT (PERMANENT, OXIDATIVE TYPE)
TYPE 2 : TWO COMPONENTS - COLORANT PART WITH HIGH LEVEL OF OILS
To be mixed immediately prior to use with oxidative part (11.8-2011 or 11.9-2011) Ingredients Maximum levels (% w/w) Oils (e.g. vegetable and/or mineral) 80 Anionic surfactants (e.g. ammonium laureth sulfate) 20 Non-ionic surfactants (e.g. laureth-12, deceth-3) 20 Amphoteric surfactants (e.g. betaine derivatives) 20 Emulsifying agents (e.g. ethoxylated long chain alcohols) 30 Soaps (e.g. ammonium hydroxide/ethanolamine oleates) 30 Solvents (e.g. propylene glycol, glycerin) 20 Thickeners (e.g. carbomer, long chain alcohols) 20 Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) 16 Hair dyeing agents: Primary intermediates (e.g. p-phenylenediamines such as p-phenylenediamine and toluene-2,5-diamine, p-aminophenols such as p-aminophenol and 4-amino-m-cresol, heterocyclic diamines such as 1-hydroxyethyl 4,5-diamino pyrazole sulfate) 6 Couplers (e.g. m-aminophenols such as m-aminophenol and 4-amino-2-hydroxytoluene, m-phenylenediamines such as 2-amino-4-hydroxyethylamino-anisole, resorcinols such as resorcinol and 4-chlororesorcinol, pyridines such as 2,6-dihydroxy-3,4-dimethylpyridine, naphtols such as 1 ,5-naphthalenediol) 6 Directs (e.g. HC red no. 3, 2-amino-6-chloro-4-nitrophenol, basic yellow 87) 6 Alkaline agents 10 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine) 5
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Cationic polymers (e.g. polyquaternium-6) 5 Additional ingredients (e.g. hair conditioning agents, pearlescent agents) 5 Antioxidants (e.g. ascorbic acid) 3 Reducing agents 3 Parfum 2 Chelating agents (e.g. EDTA) 1 Aqua to 100 pH value: 8 - 11.6 pH value of the mixture with oxidative part: 8 - 11.6 * maximum concentration of ammonium hydroxide permitted is 6 %
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Frame formulation Number: 11.6 - 2011
HAIR COLORANT (PERMANENT, OXIDATIVE TYPE)
TYPE 3 : THREE COMPONENTS - COLORANT PART - PART A
Part A (11.6-2011) and Part B (11.7-2011) to be mixed immediately prior to use with oxidative part (11.8-2011 or 11.9-2011) Ingredients Maximum levels (% w/w) Alkaline agents (e.g. ammonium hydroxide*, ethanolamine) 22 Solvents (e.g. propylene glycol, glycerin) 20 Hair dyeing agents: Primary intermediates (e.g. p-phenylenediamines such as p-phenylenediamine and toluene-2,5-diamine, p-aminophenols such as p-aminophenol and 4-amino-m-cresol, heterocyclic diamines such as 1-hydroxyethyl 4,5-diamino pyrazole sulfate) 10 Couplers (e.g. m-aminophenols such as m-aminophenol and 4-amino-2-hydroxytoluene, m-phenylenediamines such as 2-amino-4-hydroxyethylamino-anisole, resorcinols such as resorcinol and 4-chlororesorcinol, pyridines such as 2,6-dihydroxy-3,4-dimethylpyridine, naphtols such as 1 ,5-naphthalenediol) 10 Directs (e.g. HC red no. 3, 2-amino-6-chloro-4-nitrophenol, basic yellow 87) 10 Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) 16 Thickeners (e.g. cellulose derivatives) 10 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine) 5 Cationic polymers (e.g. polyquaternium-6) 5 Additional ingredients (e.g. hair conditioning agents, pearlescent agents) 5 Antioxidants, reducing agents (e.g. ascorbic acid, sodium metabisulfite) 3 Parfum 2 Chelating agents (e.g. EDTA) 1 Aqua to 100
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pH value: 8 - 11.6 pH value of the mixture Part A, Part B and oxidative part: 8 - 11.6 * maximum concentration of ammonium hydroxide permitted is 6 %
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Frame formulation Number: 11.7 - 2011
HAIR COLORANT (PERMANENT, OXIDATIVE TYPE)
TYPE 3 : THREE COMPONENTS - COLORANT PART - PART B
Part A (11.6-2011) and Part B (11.7-2011) to be mixed immediately prior to use with oxidative part (11.8-2011 or 11.9-2011) Ingredients Maximum levels (% w/w) Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 20 Emollients, humectants (e.g. octyldodecanol) 20 Thickeners (e.g. bentonite, fatty esters) 20 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine) 5 Additional ingredients (e.g. hair conditioning agents, antioxidants) 5 Parfum 2 Chelating agents (e.g. EDTA) 1 Oils (e.g.vegetable and/or mineral) to 100 pH value of the mixture Part A, Part B and oxidative part: 8 - 11.6
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Frame formulation Number: 11.8 - 2011
HAIR COLORANT (PERMANENT, OXIDATIVE TYPE)
TYPE 1 : TWO OR THREE COMPONENTS - OXIDATIVE PART
To be mixed immediately prior to use with colourant part (11.4-2011 or 11.5-2011 or 11.6-2011 + 11.7-2011) Ingredients Maximum levels (% w/w) Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 15 Hydrogen peroxide 12 Humectants (e.g. glycerin) 10 Parfum 2 Chelating agents 0.5 Hydrogen peroxide stabilising agents (e.g. sodium stannate) 0.5 pH adjuster (e.g. phosphoric acid) qs pH 2 - 3 Aqua to 100 pH value of the mixture with colourant part: 8 - 11.6
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Frame formulation Number: 11.9 - 2011
HAIR COLORANT (PERMANENT, OXIDATIVE TYPE)
TYPE 2 : TWO OR THREE COMPONENTS - OXIDATIVE PART WITH HIGH LEVEL OF OILS
To be mixed immediately prior to use with colourant part (11.4-2011 or 11.5-2011 or 11.6-2011 + 11.7-2011) Ingredients Maximum levels (% w/w) Oils (e.g. vegetable and/or mineral) 80 Thickeners (e.g. long chain alcohols, acrylates copolymer) 15 Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 15 Hydrogen peroxide 12 Humectants (e.g. glycerin) 10 Additional ingredients (e.g. hair conditioning agents) 5 Parfum 2 Chelating agents 0.5 Hydrogen peroxide stabilising agents (e.g. sodium stannate) 0.5 pH adjuster (e.g. phosphoric acid) qs pH 2 - 3 Aqua to 100 pH value of the mixture with colourant part: 8 - 11.6
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Frame formulation Number: 11.10 - 2011
DYE REMOVER (REDUCING TYPE) - PART A To be mixed immediately prior to use with part B (11.11-2011) Ingredients Maximum levels (% w/w) Acid: citric acid 13 Aqua to 100 pH value: 1.5 - 2
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Frame formulation Number: 11.11 - 2011
DYE REMOVER (REDUCING TYPE) - PART B To be mixed immediately prior to use with part A (11.10-2011) Ingredients Maximum levels (% w/w) Reducing agent (e.g. sodium hydroxymethane sulfonate) 20 Aqua to 100 pH value: 10 - 11
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Frame formulation Number: 11.12 - 2011
DYE REMOVER (OXIDATIVE TYPE) - PART A to be mixed immediately prior to use with Dye remover (oxidative type) - Part B Ingredients Maximum levels (% w/w) Ammonium / sodium / potassium persulfate 70 Oils (e.g. vegetable and/or mineral) 50 Bulking agents (e.g. kaolin, magnesium stearate) 50 Alkaline agents including ammonium hydroxide liberators (e.g. sodium/magnesium silicate, sodium carbonate, sodium metasilicate, ammonium chloride) 45 Emulsifying agents (e.g. sodium lauryl sulfate) 15 Thickeners (e.g. guar gum) 5 Additional ingredients (e.g. colorants, chelating agents) 5 pH value of the mixture Part A + Part B: 9.5 - 11.5
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Frame formulation Number: 11.13 - 2011
DYE REMOVER (OXIDATIVE TYPE) - PART B to be mixed immediately prior to use with Dye remover (oxidative type) - Part A Ingredients Maximum levels (% w/w) Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 15 Hydrogen peroxide 12 Humectants (e.g. glycerin) 10 Oils (e.g.vegetable and/or mineral) 5 Parfum 2 Chelating agents 0.5 Hydrogen peroxide stabilising agents (e.g. sodium stannate) 0.5 pH adjuster (e.g. phosphoric acid) qs pH 2 - 3 Aqua to 100 pH value of the mixture Part A + Part B: 9.5 - 11.5
HAIR BLEACH - POWDER TO BE MIXED IMMEDIATELY PRIOR TO USE: WITH AQUA FOR USE ALONE OR WITH OXIDATIVE PART (11.17-2011 OR 11.18-2011) OR WITH OXIDATIVE AND ALKALINE PARTS (11.17-2011 OR 11.18-2011 AND 11.19-2011) Ingredients Maximum levels (% w/w) Ammonium / sodium / potassium persulfate 70 Bulking agents (e.g. kaolin, magnesium stearate) 50 Alkaline agents including ammonium hydroxide liberators (e.g. sodium carbonate, sodium/magnesium silicate, sodium metasilicate, ammonium chloride) 45 Emulsifying agents (e.g. sodium lauryl sulfate) 15 Thickeners (e.g. guar gum) 5 Oils (e.g. vegetable and/or mineral) 5 Additional ingredients (e.g. Colorants, chelating agents) 5 pH value at 1 % powder in water: 10 - 11 pH value of the different mixtures: 9.5 - 11.5
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Frame formulation Number: 11.16 - 2011
HAIR BLEACH - PASTE TO BE MIXED IMMEDIATELY PRIOR TO USE WITH OXIDATIVE PART (11.17-2011 OR 11.18-2011) OR WITH OXIDATIVE AND ALKALINE PARTS (11.17-2011 OR 11.18-2011 AND 11.19-2011) Ingredients Maximum levels (% w/w) Ammonium / sodium / potassium persulfate 70 Oils (e.g. vegetable and/or mineral) 50 Bulking agents (e.g. kaolin, magnesium stearate) 50 Alkaline agents including ammonium hydroxide liberators (e.g. sodium/magnesium silicate, sodium carbonate, sodium metasilicate, ammonium chloride) 45 Emulsifying agents (e.g. sodium lauryl sulfate) 15 Thickeners (e.g. guar gum) 5 Additional ingredients (e.g. Colorants, chelating agents) 5 pH value of the different mixtures: 9.5 - 11.5
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Frame formulation Number: 11.17 - 2011
HAIR BLEACH - OXIDATIVE PART - TYPE 1 TO BE MIXED IMMEDIATELY PRIOR TO USE WITH : - HAIR BLEACH POWDER (11.15-2011) OR HAIR BLEACH POWDER + ALKALINE PART (11.15-2011 + 11.19-2011) - HAIR BLEACH PASTE (11.16-2011) OR HAIR BLEACH PASTE + ALKALINE PART(11.16-2011 + 11.19-2011) Ingredients Maximum levels (% w/w) Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 15 Hydrogen peroxide 12 Humectants (e.g. glycerin) 10 Oils (e.g.vegetable and/or mineral) 5 Parfum 2 Chelating agents 0.5 Hydrogen peroxide stabilising agents (e.g. sodium stannate) 0.5 pH adjuster (e.g. phosphoric acid) qs pH 2 - 3 Aqua to 100 pH value of the different mixtures: 9.5 - 11.5
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Frame formulation Number: 11.18 - 2011
HAIR BLEACH - OXIDATIVE PART - TYPE 2 TO BE MIXED IMMEDIATELY PRIOR TO USE WITH : - HAIR BLEACH POWDER (11.15-2011) OR HAIR BLEACH POWDER + ALKALINE PART (11.15-2011 + 11.19-2011) - HAIR BLEACH PASTE (11.16-2011) OR HAIR BLEACH PASTE + ALKALINE PART (11.16-2011 + 11.19-2011) Ingredients Maximum levels (% w/w) Oils (e.g.vegetable and/or mineral) 80 Thickeners (e.g. long chain alcohols, acrylates copolymer) 15 Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. ethoxylated long chain alcohols) 15 Hydrogen peroxide 12 Humectants (e.g. glycerin) 10 Additional ingredients (e.g. hair conditioning agents) 5 Parfum 2 Chelating agents 0.5 Hydrogen peroxide stabilising agents (e.g. sodium stannate) 0.5 pH adjuster (e.g. phosphoric acid) qs pH 2 - 3 Aqua to 100 pH value of the different mixtures: 9.5 - 11.5
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Frame formulation Number: 11.19 - 2011
HAIR BLEACH - ALKALINE PART TO BE MIXED IMMEDIATELY PRIOR TO USE WITH : - HAIR BLEACH POWDER (11.15-2011) + OXIDATIVE PART (11.17-2011 OR 11.18-2011) - HAIR BLEACH PASTE (11.16-2011) + OXIDATIVE PART (11.17-2011 OR 11.18-2011) Ingredients Maximum levels (% w/w) Anionic surfactants (e.g. ammonium laureth sulfate) 20 Non-ionic surfactants (e.g. laureth-12, deceth-3) 20 Amphoteric surfactants (e.g. betaine derivatives) 20 Emulsifying agents (e.g. ethoxylated long chain alcohols) 30 Soaps (e.g. ammonium hydroxide/ethanolamine oleates) 30 Solvents (e.g. propylene glycol, glycerin) 20 Thickeners (e.g. carbomer, long chain alcohols) 20 Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) 16 Alkaline agents (e.g. ammonium hydroxide*, ethanolamine) 10 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride, PEG-2 oleamine) 5 Cationic polymers (e.g. polyquaternium-6) 5 Additional ingredients (e.g. hair conditioning agents, pearlescent agents) 5 Parfum 2 Chelating agents (e.g. EDTA) 1 Aqua to 100 pH value: 8 - 11.6 pH value of the different mixtures: 9.5 - 11.5 * maximum concentration of ammonium hydroxide permitted is 6 %
PERMANENT WAVE LOTION - TWO-COMPONENTS – BASED ON HYDROGENPEROXIDE AND REDUCING AGENTS- PART A
To be mixed prior to use with part B (12.14-2011), the mixing of parts A and B is exothermic Ingredients Maximum levels (% w/w) Hydrogen peroxide 12 Non-ionic surfactants 5 Hair conditioning agents (e.g. proteins) 1 Stabilising agents 0.5 Aqua to 100 pH value: 2.5 - 3.5 pH value of the ready-to-use mixture (parts A and B): 7 - 9.5
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Frame formulation Number: 12.14 - 2011 PERMANENT WAVE LOTION - TWO COMPONENTS – BASED ON HYDROGEN PEROXIDE
AND REDUCING AGENTS - PART B To be mixed prior to use with part A (12.13-2011), the mixing of parts A and B is exothermic Ingredients Maximum levels (% w/w)
Reducing agent: Ammonium thioglycolate 20 * Alkaline agents (e.g. ammonium hydroxide, ethanolamine, ammonium bicarbonate) 8 Anionic / non-ionic / amphoteric surfactants (e.g. betaine derivatives ) 3 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride) 3 Parfum 1 Colorants 1 Opacifying agents 0.5 Aqua to 100 * before exothermic reaction with hydrogen peroxide pH value: 7 - 9.5 pH value of the ready-to-use mixture (parts A and B): 7 - 9.5
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Frame formulation Number: 12.15 - 2011 PERMANENT WAVE LOTION - TWO COMPONENTS – BASED ON REDUCING AGENTS -
PART A To be mixed prior to use with part B (12.16-2011) Ingredients Maximum levels (% w/w) Reducing agent : Thioglycolate ester(e.g. glyceryl thioglycolate) 99 Glycerin 50 pH value of the ready-to-use mixture (parts A and B): 6.5 - 9
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Frame formulation Number: 12.16 - 2011
PERMANENT WAVE LOTION - TWO COMPONENTS – BASED ON REDUCING AGENTS – PART B
To be mixed prior to use with part A (12.15-2011) Ingredients Maximum levels (% w/w) Reducing agents, e.g.: - ammonium thioglycolate 5 - cysteine HCl 10 - ethanolamine thioglycolate 1 Anionic / non-ionic / amphoteric surfactants (e.g. betaine derivatives) 10 Cationic surfactants ≥ C12 (e.g. dicetyldimonium chloride) 5 Alkaline agents (e.g. ammonium hydroxide, ethanolamine, ammonium bicarbonate) 5 Silicones (e.g. amodimethicone), silanes (e.g. alcoxysilanes) 5 Diammonium dithiodiglycolate 4 Hair conditioning agents (e.g. proteins, polymers) 2 Opacifying agents 1 Parfum 1 Aqua to 100 pH value: 8 - 9.5 pH value of the ready-to-use mixture (parts A and B): 6.5 - 9
HAIR STRAIGHTENER (RELAXER) - TYPE 1 Cream type based on lye Ingredients Maximum levels (% w/w) Oils (e.g. vegetable and/or mineral) and waxes 80 Emollients, humectants (e.g. lanolin, cholesterol) 30 Anionic / non-ionic / amphoteric surfactants (e.g. polysorbate 60) 15 Emulsifying agents (e.g. cetyl alcohol, stearyl alcohol, oleyl alcohol and their ethoxylates) 15 Additional ingredients (e.g. plant extracts) 5 Straightening agents (e.g. sodium hydroxide, potassium hydroxide, lithium hydroxide, calcium hydroxide) 4.5 Hair conditioning agents (e.g. proteins, polymers) 2 Parfum 1 Aqua to 100 pH value: 11.0 - 13.5
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Frame formulation Number: 12.19 - 2011
HAIR STRAIGHTENER (RELAXER) - TYPE 2 - PART A Part A (No lye type cream base) to be mixed prior to use with part B (activator) (12.20-2011) Ingredients Maximum levels (% w/w) Straightening agents, e.g. - calcium hydroxide 10 * - potassium citrate 10 Oils (e.g. vegetable and/or mineral), waxes and fats 80 Humectants, emollients (e.g. lanolin, cholesterol) 30 Anionic / non-ionic / amphoteric surfactants (e.g. betaine derivatives) 10 Emulsifying agents (e.g. long chain alcohols and their ethoxylates) 10 Hair conditioning agents (e.g. proteins, polymers) 5 Additional ingredients (e.g. plant extracts) 5 Parfum 1 Aqua to 100 * the mix with part B activator generates an alkaline mix of up to 5 % alkali calculated as calcium hydroxide. pH value: 11 - 13 pH value of the mixture (part A cream base and part B activator): 11 - 13.5
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Frame formulation Number: 12.20 - 2011
HAIR STRAIGHTENER (RELAXER) - TYPE 2 - PART B Part B (Activator) to be mixed prior to use with part A (cream base) (12.19-2011) Ingredients Maximum levels (% w/w) Straightening agents, e.g. - calcium hydroxide 40 - guanidine carbonate 30 Polymers, resins, hair conditioning agents 5 Additional ingredients (e.g. humectants such as sorbitol) 5 Parfum 1 Colorants 1 Aqua to 100 pH value: 10 - 13 pH value of the mixture (part A cream and part B activator): 11 - 13.5
* actual weight present will depend on M.Wt. of fluorine donor, e.g. 0.15% fluorine = 1.14 % MFP (monofluorophosphate) or 0.333 % NaF (sodium fluoride)
221
Frame formulation Number: 17.1 - 2011
MOUTHWASH Ingredients Maximum levels (% w/w) Ethanol (alcohol, alcohol denat.) 25 Humectants (e.g. sorbitol) 20 Additional ingredients (e.g. vitamins ) 5 Flavour (mostly essential oils e.g. mint) 3 Anionic / amphoteric / non-ionic surfactants (e.g. sodium lauryl sulfate, polysorbate) 3 Colorants 3 Emulsifying agents (e.g. PEG-60, hydrogenated castor oil) 1 Preservatives, antimicrobials 1 Oral care-deodorant (e.g. zinc chloride) 0.5 Thickeners (e.g. cellulose derivatives) 0.5 Oral care-sweetening agents (e.g. sodium saccharin) 0.2 Fluoride compounds (calculated as Fluorine) 0.15 * Aqua to 100 * actual weight present will depend on M.Wt. of fluorine donor, e.g. 0.15% fluorine = 1.14 % MFP (monofluorophosphate) or 0.333 % NaF (sodium fluoride)
Face care products other than face mask Face mask Eye contour products Lip care products Hand care products Foot care products Body care products External intimate care products Chemical exfoliation products Mechanical exfoliation products Skin lightening products
Make-up products Foundation Concealer Other face make-up products Mascara Eye shadow Eye pencil Eye liner Other eye make-up products Lip stick Lipstick sealer Other lip make-up products Body or face paint , including "carneval make-up"
Other make-up products
Perfumes
Hydroalcoholic perfumes Non hydroalcoholic perfumes
Sun and self-tanning products Before and after sun products Sun protection products Self-tanning products
Other sun and self-tanning products
Other skin products
226
Other skin products
Hair and scalp products Hair and scalp care and cleansing products
Shampoo Hair conditioner Scalp and hair roots care products Antidandruff products Antihairloss products
Other hair and scalp care and cleansing products Hair colouring products