Mutual recognition - media.simplicityweb.commedia.simplicityweb.com/chemicalwatch/biocideshub/201405symp/2.1...Biocide-Regulation 528/2012 (BPR), mutual recognition after 1 September

MUTUAL RECOGNITION

Application for mutual recognition according to the BPR submitted before and after 1 September 2013, including transitional measures

Martin Ahlhaus

Biocides Symposium 2014 in Bratislava 22-23 May 2014

Content

1 Biocide-Directive 98/8 (BPD), mutual recognition before 1 September 2013

2 Biocide-Regulation 528/2012 (BPR), mutual recognition after 1 September 2013

3 Mutual recognition in sequence

4 Mutual recognition in parallel

5 Referral of objections, derogation and legal remedies

6 Transitional measures

Biocide-Directive 98/8 (BPD)

1 ■ Annex I: biocidal products ■ Annex IA: low-risk biocidal products ■ Annex IB: basic substances

Inclusion of an active substance in Annex I, IA or IB

2

■ Authorisation for products containing active substances as listed in Annex I, Article 3(1) BPD, or

■ Registration for low-risk products containing active substances as listed in Annex IA, Article 3(2)(i) BPD, or

■ Neither authorisation nor registration for basic substances listed in Annex IB, Article 3(2)(ii) BPD

■ Mutual recognition, Article 4 BPD

Authorisation or registration by a Member State

Mutual recognition before 1 September 2013

Substance is included in Annex I or IA

Authorisation or registration in one MS

Substance conforms to the requirements

Prerequisites

Authorisation within 120 days by the other MS

Registration (low-risk) within 60 days by the other MS

If the MSs disagree, the Com decides

Process or or

Certified copy of the initial authorisation

Formalities Application for MR to another MS

Summary of the dossier

Reasons for change

■ Mutual recognition in parallel in BPR

Recital (41) BPR: “To enable closer cooperation between Member States in the evaluation of biocidal products and to facilitate biocidal products’ market access, it should be possible to launch the mutual recognition procedure when applying for the first national authorisation.”

Biocide-Regulation 528/2012 (BPR)

1

■ Inclusion in a Union list of approved active substances, Article 9(2) BPR

Approval of active substance, Article 4 BPR

2

■ Simplified authorisation procedure, Article 25-27 BPR no need for mutual recognition, only notification, valid throughout the Union, Article 27(1) BPR

■ Union authorisation, Article 41-46 BPR

no need for mutual recognition, valid throughout the Union unless otherwise specified, Article 41 BPR

■ National authorisation, Article 29-31 BPR ■ Mutual recognition, Article 32-40 BPR

■ “low-risk-products”, Article 25 BPR

■ other than “low-risk

products”, Article 20 BPR

Authorisation for making available on the market and use of biocidal products, Article 17 BPR

Mutual recognition after 1 September 2013

Mutual recognition in sequence, Article 33 BPR

National authorisation already granted in one MS

Mutual recognition in parallel, Article 34 BPR

Product not yet authorised in any MS

Recognition in parallel

Recognition in parallel

Recognition in parallel

Application

Initial authorisati

on

Recognition in sequence

Recognition in sequence

Application

Mutual recognition in sequence

After initial authorisation, one application to the competent authorities in each MS, each containing a translation of the initial authorisation in whatever official language the MS requires

Austria

Slovakia

UK Application for MR

German authorisatio

n

translated German

authorisation

Application for initial

authorisation Germany UK

recognition

Slovakian recognition

translated German

authorisation

Austrian recognition

German authorisatio

n

Agreeing on summary

Agreeing on summary

Mutual recognition in parallel Application for initial authorisation at the same time as the application for mutual recognition

Application for initial

authorisation

Application for MR

Application for MR

Germany Austria Slovakia

German authorisatio

n

Austrian recognition

Slovakian recognition

Application for MR

UK

UK recognition

Agreeing on summary Agreeing on summary Agreeing on summary

Formalities

Mutual recognition in sequence Mutual recognition in parallel

Application for (intitial) authorisation to the competent authority in reference MS of its choice containing:

▪ A dossier or letter of access as in Annex II and III ▪ Summary of characteristics referred to in Article 22(2) BPR, except for lit. (c) and (d)

▪ List of other MS where a national authorisation is sought (“MS concerned”)

Applications for mutual recognition to the competent authorities of each MS concerned containing:

▪ Translation of the initial authorisation granted by the reference MS in each official language

▪ Names of the reference MS and the other MS concerned

▪ Summary of characteristics referred to in Article 22(2) BPR, except for lit. (c) and (d)

Mutual recognition in sequence

Application to the competent authorities of each MS concerned

If no agreement is reached within 90 days, each MS that agrees may authorise the product accordingly

Information by MS concerned about the fees payable

Acceptance of the application upon receipt of the payment or Rejection if fees are not paid by the applicant within 30 days of the information

Validation of the application by the MSs concerned within 30 days of acceptance and Information about the validation to the applicant

Agreement between the MSs concerned on the summary of biocidal products characteristics within 90 days of validation

Authorisation of the biocidal product within 30 days of reaching an agreement by each of the MS concerned

Mutual recognition in parallel

Application to the competent authorities of each MS concerned

Information by MS concerned about the fees payable

Acceptance of the application upon receipt of the payment or Rejection if fees are not paid by the applicant within 30 days of the information

Validation of the application by the reference MS within 30 days of acceptance and Information about the validation to the applicant and the MSs concerned

Evaluation of the application by the reference MS and draft of an assessment report within 365 days of validation, sending report and summary to MS concerned and applicant

If no agreement is reached within 90 days, each MS that agrees may authorise the product accordingly

Authorisation of the biocidal product within 30 days of reaching an agreement by each of the MS concerned

Agreement between the MSs concerned on the summary of biocidal products characteristics within 90 days of receipt of documents

Referral of objections, Article 35 BPR

■ If any MS is of the opinion, that a product does not meet the criteria for granting an authorisation, it shall send a detailed explanation to all parties involved

■ A coordination group of all MS involved shall use their best endeavours to reach an agreement

■ If no agreement is reached within 60 days, the Commission decides

Derogation of mutual recognition, Article 37 BPR

MS may refuse mutual recognition or adjust terms and conditions on the grounds of

■ protection of the environment

■ public policy or public security

■ protection of health and life of humans

■ protection of national treasures

■ target organisms not being present in harmful quantities

Legal remedies

■ Appeals against decisions of the Agency on rejection of applications lie with the REACH-Board of Appeal, Article 77 BPR

■ Appeals against decisions of the national authorities lie with the national courts

Transitional measures

NOTE: Regulation 334/2014 amending BPR is in force since 25 April 2014, consolidated version not yet available, various amendments, e.g. regarding time frame for transitional measures

Transitional measures

Article 89 BPR (Transitional measures for national law)

Article 95 BPD (Access to the active substances dossier)

Article 90 BPR (Active substances evaluated under BPD)

Article 91 BPR (Applications for authorisation submitted under BPD)

Article 92 BPD (Products authorised/registered under BPD)

Article 93 BPD (Products not covered by BPD)

Article 94 BPD (Treated articles)

Transitional measures in Article 91 and 92 BPR

■ Article 91(1) BPR: Application for authorisation BPD

1 September 2012 1 September 2013 1 September 2014

■ Article 92(2) BPR: everything else BPD BPR

BPD ■ Article 92(1) BPR: Authorisation or registration

Transitional measures in Article 89(3) BPR: National law - BPR

■ ECHA: “Once an active substance is formally included in the list of approved substances, all biocidal products containing that substance must be formally authorised in accordance with the provisions of the Regulation and the conditions of approval of the active substance.”

■ Article 89(3) BPR: Three year period for MS to grant/modify/cancel authorisation according to BPR after approval of an existing substance, if product is already on the market according to national law and contains only existing substances.

‒ application for authorisation or MR in parallel no later than date of approval of the substance (List of dates of approval: http://webcommunities.hse.gov.uk/connect.ti/pesticides/view?objectId=8772 )

‒ Without application: 180/365 days phase-out after the date of approval for making available or using that product

‒ Rejection: 180/365 days phase-out after the date of decision for making available or using that product

■ Product Compliance ■ International Trade & Logistics ■ Environmental Law ■ Chemicals Regulation (REACH, CLP, Biocides) Martin Ahlhaus has years of experience in product compliance

projects. He is a member of several expert groups at the Federation of German Industries (BDI e.V.). Martin Ahlhaus is recognized for his ‘world class’ expertise in EU and public environmental law” (Who’s Who Legal, Germany 2012) and identified by peers as „one of the best in Europe“ (Who‘s Who Legal, Germany 2013). „Clients value his ‚creativity‘ and ‚can-do attitude‘“ (Who‘s Who Legal, Germany 2014).

Heading the environmental practice at Noerr he is specialized in environmental questions in production and trade. He regularly lectures on various topics in the field of product compliance and effects on international trade.

Languages: German (native language) English

Martin Ahlhaus Rechtsanwalt Dipl.-Verwaltungswirt (FH) T +49 89 286 28 284 M +49 160 88 67 804 [email protected] Noerr LLP Brienner Str. 28 80333 Munich