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&REACH Implications

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REACH (and CLP) impacts only on legal entities based in the 31 countries of EU+EEA (‘EU’)

REACH role:EU-based substance importer (I)EU-based substance manufacturer (M)EU-based only representative (OR) of a non-EU

substancemanufacturer

or a combination of these roles…

REACH obligations for non-EU manufacturer? None. However, it is good business sense to support EU customers (importers) and protect CBI by using an only representative

Back to basics:

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EU, EEA and EFTA:

Member countries of the EU (year of entry)Austria (1995), Belgium (1958), Bulgaria (2007), Croatia (2013), Cyprus (2004), Czech Republic (2004), Denmark (1973), Estonia (2004), Finland (1995), France (1958), Germany (1958), Greece (1981), Hungary (2004), Ireland (1973), Italy (1958), Latvia (2004), Lithuania (2004), Luxembourg (1958), Malta (2004), Netherlands (1958), Poland (2004), Portugal (1986), Romania (2007), Slovakia (2004), Slovenia (2004), Spain (1986), Sweden (1995), United Kingdom (1973)

The European Economic Area (EEA) - The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows these countries to be part of the EU’s single market

European Free Trade Agreement (EFTA) - Switzerland is neither an EU nor EEA member but is part of the EFTA single market. REACH does not apply in Switzerland.

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Country Registrations SubstancesGermany 11,677 5,149United Kingdom 5,488 2,249France 4,008 1,989Netherlands 3,932 1,762

Italy 3,511 1,768

REACH registrations: (ECHA - May 2016)

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Country M I M/I ORGermany 26% 27% 38% 16%

United Kingdom 7% 13% 7% 23%France 11% 8% 9% 6%Netherlands 4% 13% 7% 12%Italy 11% 8% 8% 1%

REACH registration roles - % of EEA: (ECHA - May 2016)

M manufacturerI importerM/I manufacturer and importerOR only representative of non-EU manufacturer

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Assume Full Exit – “Swiss Model”

1. No REACH obligations for UK-based M/I s2. All existing registrations become ‘invalid’ (including

those submitted in 2018)3. Dossier updates, evaluation, authorisation, restriction,

new substance registrations etc shall no longer apply to UK actors

4. UK-based ORs can no longer operate5. Exports from UK to EU: let your importer (customer)

register or nominate an OR in an EU country

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Swiss model (Case Study 1): UK substance manufacturer

• No EU-REACH obligations• If exporting to EU can consider three options:

1. support importer’s (customer’s) REACH compliance2. establish an OR in the EU (good business sense)3. do nothing (export subject to usual T&Cs)

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Swiss model (Case Study 2): UK substance importer

• No EU-REACH obligations• Can import substance/s from any manufacturer

worldwide (subject to UK import requirements)

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Swiss model (Case Study 3): UK-based only representative

Can no longer act as an OR, meaning that EU-based importers relying on that OR registration are non-compliant.

Action• Non-EU substance manufacturer must nominate an

alternative OR located within the EU• OR-to-OR legal entity transfer (best to complete

before Brexit is fully effected otherwise a whole new registration may be needed by the new OR)

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Other considerations:

• If the UK registrant (M, I OR) is a lead registrant (LR) then the substance co-registrants must agree an alternative LR based in the EU and transfer the role to the new LR before Brexit is effected

• Data ownership disputes/discussions may arise

• Be informed and keep your value chain informed

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Conclusions:

• Based on the Brexit Swiss model, UK-based M/I/ORs shall no longer have EU-REACH obligations

• Biggest impact will be on existing, UK-based ORs• Non-EU manufacturers using a UK OR need to make

transfer provisions to an OR based in another EU country

• Exporters from UK to EU can plan for a smooth transition with customers – OR option will protect CBI and support those customers

• Plan in advance to mitigate cost, admin and possible supply chain disruption.

• In reality, an EAA (Norway model) or EFTA (Swiss model) may result, or a third option may be negotiated. Regardless, post-Brexit REACH planning should start now.

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THANK YOU

Dr Keven HarlowREACHLaw ( UK & Ireland)Phone: + 44 7800 85 0692

Email: keven.harlow@reachlaw.fi