brexit - what next (da presentation) - steptoe & johnson€¦ · bpr authorisations and brexit...

Brexit - What next?

Internal Market Uncertainty - Defensive Strategies

Membership Meeting, BrusselsWednesday 23 November 2016

Darren Abrahams© Copyright 2016 Steptoe & Johnson LLP

www.steptoe.com 2

Defensive Strategies: Focus on REACH & Biocides

– Build (redundant) compliance models

– Check upstream supply chain undertakings

– Market Surveillance

– Issue Flagging

4

Current REACH Compliance Models: UK “OR”

5

http://www.nationsonline.org/oneworld/europe_map.htm

Importer (& Possibly Distributor)

Only Representative

Downstream User

Downstream User

Downstream User

Current REACH Compliance Models: UK Importer

6

http://www.nationsonline.org/oneworld/europe_map.htm

Distributor

Importer

Downstream User

Downstream User

Downstream User

Current REACH Compliance Models: UK Super Importer

7

http://www.nationsonline.org/oneworld/europe_map.htm

Distributor

“Super” Importer

Downstream User

Downstream User

Downstream User

Defensive Strategies

– Check upstream supply chain undertakings

Contractual compliance undertakings: Current non-EU manufacturers (OR’s) UK importers EU 27 importer undertakings Review/Amendment of Distribution Agreements

Fit for purpose, compliance with applicable law, bestefforts, indemnities etc.

8

Defensive Strategies

– Build (redundant) safeguard systems

OR transfers: Contractual transfer mechanism? Documented consent? New OR agreement? Define trigger event/mechanism REACH IT transfer & ECHA fee Formal notification of EU importers

Changing Physical Supply Route: Lean towards EU 27 ?

9

Defensive Strategies

– Market surveillance

Even if EU law applies in full up to BREXIT date: risk of free-riders? compliance drop-off post Article 50 notification? 31 May 2018 registration deadline (v. March 2017

+2 years Brexit window) companies ‘hedging bets’ re enforcement reduction of UK enforcement efforts?

Ensure your necessary compliance does notbecome a competitive disadvantage.

10

Defensive Strategies

– Issue flagging PPORD exemption if manufactured or imported in UK

– remainder of 5 years still applies?

Lead registrant and its joint registration status?– replacement? transitional arrangements?

Obligations on UK registrants:– pay for and provide further studies under substance

evaluation?

– SIEF mandatory data sharing – strategically draw outnegotiations…

– dossier compliance check draft decisions?– restrictions on placing on the market/uses, or under

authorisation?

11

BPR Article 95 list As of 1 Sept. 2015 those who (i) do not have access to a "complete

substance dossier" and (ii) therefore have not been included on the listof approved sources drawn up by ECHA by are excluded from themarket:

– Biocidal products "consisting of, containing or generating a relevantsubstance…shall not be made available [i.e. "any supply"] on the market orused unless either the substance supplier or the product supplier is included inthe list…for the product-type(s) to which the product belongs".

• "Substance supplier": "who manufactures [in EU] or imports [into EU] a relevantsubstance, on its own or in biocidal products" (No "Only Representative" role todisplace EU importer)

• "Product supplier": "who manufactures [in EU] or makes available on the market abiocidal product consisting of, containing or generating that relevant substance “

• Data Submitters: of a "complete dossier" under the Review Programme Regulation(Participants) or Supporters of New AS or "third party" AS dossiers submitted along witha Product authorisation, will also be included in list

www.steptoe.com 12

Current BPR Compliance Models: Art. 95 Representative

13

http://www.nationsonline.org/oneworld/europe_map.htm

Importer

EU Representative

Customers

CustomersCustomers

BPR authorisations and BREXIT

14www.steptoe.com

Move away from UK for “mutual recognition” of product authorisations

under the BPR?

www.steptoe.com 15

Darren Abrahams

English barrister, Avocat at the Brussels Bar, and Steptoe partner resident in Brussels

Focuses on EU regulatory requirements and the related commercial issues in the environment, chemicals, and life sciences areas. Works on: • Advocacy and representation before the CJEU, Board

of Appeal of ECHA, EU institutions and agencies, and national authorities

• Product defence and product approvals in the chemicals (REACH, CLP, biocides, agrochemicals, cosmetics) and biotechnology (genetically modified food, feed and plants) areas

• Due Diligence aspects of international transactions• Regulatory compliance programs and obtaining

licenses to operate • Commercial impacts of new EU regulatory initiatives,

and advocacy to help shape clients’ legislative and policy environment

16www.steptoe.com