The implementation of REACH: rising to the challenge · 2015-07-01 · UNIPRO / Cosmoprof, Bologna, 11 April 2008 Contents I. The EU REACH Regulation and available technical guidance

UNIPRO / Cosmoprof, Bologna, 11 April 2008

The implementationof REACH:rising to the challenge

Manuela Coroama, Colipa


Contents

I. The EU REACH Regulation and availabletechnical guidance

II. Colipa and the implementation processIII. Guidance to members « how to prepare for

the implementation of REACH »IV. 1st Priority in the short term: pre-registrationV. External support to companiesVI. Conclusions


I. The EU REACH Regulation

Regulation of the EuropeanParliament and of the Council (1907/2006)

• adopted on 26 December 2006• entered into force on 1 June 2007


`aChallenge and opportunity!


Take action:

• be aware of and understand your obligations under REACH

• prepare – internally and with your suppliers –for the first steps: pre-registration (1.06.08 –1.12.08) and registration


Technical Guidance

European Chemicals Agency (ECHA):• Technical guidance documents available on its

website: www.echa.europa.eu

Colipa & relevant supplier organisations:• Registration under REACH of Natural & Complex

Substances used as Fragrance Ingredients

• Registration under REACH of Natural & ComplexSubstances used as Cosmetic Ingredients

(currently in progress)


II. The cosmetics industry and the implementation process

• objectives• strategy• role and tasks of Colipa• the Extranet


Industry objectives

• comply with the requirements of REACH• maintain and develop a sustainable and

competitive business environment• optimise internal/external communication• minimise the negative effects and maximise

the positive effects of REACH• maximise legal certainty• improve stakeholder confidence


Colipa strategy

• build awareness within industry• assist membership in its compliance activities• influence/optimise the implementation process• provide technical/legal support to members• identify and use appropriate tools• actively participate in further legislative work

foreseen under REACH


Role & Tasks of Colipa (1)

• act as source of information for membership• train the trainers• support and steer the implementation of the

Colipa roadmap and communication plan• provide technical/legal advice on issues that

are specific/directly relevant to the cosmeticsindustry



• build up inventory of Questions & Answers• develop guidance documents• liaise with external stakeholders at EU level• coordinate industry’s implementation

activities• draw up a roadmap of internal/external

support• actively participate in revisions and

adaptations to technical progress of the REACH Regulation



However, Colipa does not:• handle actual (pre)registration dossiers• act as an intermediary between the

cosmetics industry and individual supplier companies

• duplicate the helpdesk system being set up under REACH


Colipa Extranet for Members

• web address: www.colipa.net• internal communication tool• « REACH Implementation » page under

Issue Trackerhttp://www.colipa.net/site/index.cfm?SID=8&OBJ=13477&back=1

• electronic form for submitting questions


III. Colipa Guidance« How to prepare for implementing REACH »

• first issued in July 2006 • updated in May 2007• simplified 9-step guidance to

members• available on the Colipa Extranet /

Issue Tracker / REACH implementation


Step 1

Understand that REACH is here to stay, thatit does affect the ingredients you use, thatit will very soon change the cosmeticbusiness environment and the waycompanies operate and interact with eachother.


Step 2Establish your company’s REACH Team:• Coordinator

– plan, monitor progress, follow legislative progress and development of official guidance, regular team meetings, information flow, management of externalconsultants/technical support, decisions)

• Links with all relevant departments (R&D, purchase, IT, product safety, finance, etc.)


Step 3Establish your company’s inventory of

ingredients covered by the scope of REACH• identify ingredients, quantify• for each ingredient, identify the source(s) of supply• identify (potential) classification based on intrinsic

properties• discuss with supplier intention to (pre)register,

availability of data


Step 4Establish, for each substance, your status /

obligations under REACH

Based on the source of supply for each ingredient:• manufacturer?• importer?

– if this is the case, does your non-EU source have an « OnlyRepresentative » in the EU?

• downstream user?


Step 5Identify the available safety data (human

and environmental) for each ingredient

• within your company• discuss data gaps with your supplier• protect your intellectual property


Step 6Prioritise your ingredients, based on own

criteria, for example:• cost per annum• volume/tonnage per annum• origin (EU / non-EU)• supplier rating• difficulty to substitute• ingredients giving a unique selling point• 80-20 rule (20% of ingredients will be used in 80% of products)


Step 7Prepare your own action plan:

• establish objectives, tasks, action steps, resources, deliverables, budgets, deadlines

• monitor progress• review plan & adapt as necessary• at this stage, focus on pre-registration & data


Step 8Communicate with your suppliers: obtain

information to aid decision-making

• data availability / gaps • intention to pre-register• intention to register


Step 9Establish an efficient information

system and keep it up-to-date

• company-internal system / database(s)• tools being developed by the European

Commission (IUCLID 5) and by the supplier industry federation, CEFIC


IV. 1st Priority in the short-term

Pre-registration


Pre-registration (1)

Scope: phase-in (existing) substances manufactured/imported in quantities above1 tonne/year per manufacturer/importer

Definition of phase-in substances: Article 3.20



Information to be submitted to the Agency:• substance identification (name, EINECS,

CAS, etc.)• registrant’s name & address, contact person• envisaged deadline for registration• indication if the substance should be subject

to grouping, read-across, QSAR (quantitative structure-activity relationship)



By whom?• All potential registrants (manufacturers or importers)

of phase-in substances, including Only Representatives of non-EU manufacturers

• Downstream users must pre-register substances that they import (as such, or as part of finished products) in quantities > 1 tonne/year – unless their supplier has an Only representative – and can possibly pre-register other substances (but beware of implications – data, time, money…!)



Why?• to benefit from the tonnage-related extended

deadlines for registration-> gain time to organise the collection and selection of available data, the sharing of existing data and the collective generation of missing information

• to facilitate the formation of Substance Information Exchange Fora (SIEFs)



How?

• through the REACH IT system managed by the EuropeanChemicals Agency (ECHA):http://echa.europa.euhttp://ecbwbiu5.jrc.it/



When?

• Start: 1 June 2008• End: 1 December 2008• Total duration: 6 months


Pre-registration (7)Can substances be pre-registered after 1 Dec.

2008?No, except ifthey are manufactured/imported for the first

time into the EU, in quantities above 1 t/yafter the pre-registration period has ended

In such cases, a pre-registration can be submitted to the Agency within 6 months of manufacture/import, but not later than 12 months before the registration deadline for the relevant tonnage range.



What happens after pre-registration? (1)

• by 1 January 2009, ECHA will publish the listof substances that have been pre-registered

• the information to be published: substance names, EINECS, CAS or other identification codes and the first envisaged registration deadline


Pre-registration (9)What happens after pre-registration? (2)

• a downstream user of a substance appearingon the list may submit to ECHA any relevant information on that substance, thus expressinghis intention of being part of the relevant SIEF

• all potential registrants, downstream users, or third parties who have submitted information in the context of pre-registration, shall beparticipants in the relevant SIEFs


Pre-registration (10)What happens after pre-registration? (3)

• a downstream user of a substance not appearing on the list may notify ECHA of hisinterest, contact details and details of hissupplier

• ECHA will publish on its website the name of the substance and, on request, will provide the downstream user’s contact details to a potentialregistrant



What happens if the deadline for pre-registration is not met?

• if a company does not pre-register a phase-in substance by 1 December 2008: -> it must suspend its activities involving the

substance, or-> register it without delay (but inquire at ECHA first)

• downstream users of such a substance might be atrisk (disruption of supply, possible penalties)


Pre-registration (12)Does pre-registration ensure registration?

• pre-registration does not have to be followedby registration, for example if:– the potential registrant ceases manufacture or import of

that substance, or– the quantity manufactured or imported drops below 1

tonne/year before the registration deadline


Pre-registration (13)What can/should downstream users do?• Before pre-registration (as soon as possible):

check with your suppliers (EU and especially non-EU!) whether:– the substances that you use come under the definition of phase-in

substances, and– whether the suppliers intend to pre-register these substances

particularly difficult cases: monomers / polymers and fragrancecompounds!

• During and after pre-registration: ask your supplier for the pre-registration number of substances that you purchase from him


Pre-registration (14)What can/should downstream users do?• If a supplier does not intend to pre-register a

substance: negotiate / organise alternative source of supply

• When the list of pre-registered substances is published by ECHA, indicate intention to participate in SIEFs of interest by providing any relevant substance-related information (thus becoming a “Data holder”).


V. External support

• European Commission• The European Chemicals

Agency (ECHA)• Member States• Supplier industry• Other stakeholders


External support: Commission

• DG Enterprise/REACH (1)

• DG Environment (2)

• European Chemicals Bureau (3)

• Commission’s Navigation Tool (4)

• European Chemicals Agency (ECHA) (5)

• Techical Guidance Documents produced by the REACH Implementation Projects (RIPs) (5)


External support: Member States

For example:

• Competent authorities’ helpdesk system (6)

– Italy:Website www.helpdesk-reach.itE-mail: [email protected]

• National Associations Network (of which UNIPRO is a member)


External support: the supplier industry

For example:

• CEFIC REACH Centrum (7)

• EFFA / IFRA (fragrance materials) (8)

• EFfCI (cosmetic ingredients) (9)

• REACHReady (UK) (10)


External support: websites

(1): http://www.ec.europa.eu/enterprise/reach/index_en.htm

(2): http://www.ec.europa.eu/environment/index_en.htm

(3): http://ecb.jrc.it/reach

(4): http://reach.jrc.it/navigator_en.htm

(5): http://ec.europa.eu/echa/home_en.html


External support: websites

(6): http://www.ec.europa.eu/echa/reach/helpdesk/nationalhelp_en.html

(7): http://www.reachcentrum.org

(8): http://www.effa.behttp://www.ifraorg.org

(9): http://www.effci.org

(10): http://www.reachready.co.uk


VI. Conclusions

• be aware• prepare• be positive• join forces


Conclusions (1)

• New REACH Regulation is here to stay• REACH is both a challenge and an

opportunity for industry• Companies must get ready for compliance• If you have not yet started preparing,

START NOW!


Conclusions (2)

• Companies have the responsibility to complywith the requirements of REACH

• Colipa and National Associations have an important role to play in assisting theirmember companies in the implementationprocess

• We all have to work together to ensure as far as possible that the benefits of REACH outweigh the hurdles and that we turn thismassive challenge into a winning opportunity.


Remember:

the clock ( ?) is ticking!