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Media Centre >> News >> Eurofins | Newsflash - March 2019 | Brexit: Cosmetics & Chemicals

Eurofins | Newsflash - March 2019 | Brexit: Cosmetics & Chemicals

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Friday, March 8, 2019

Toys & Cosmetics

 

UK

 

BREXIT: the countdown

 

On 29th March 2017, the Government of the United Kingdom (UK) submitted the notification of its intention to withdraw from European Union (EU) according to Article 50 of the Treaty on European Union. The UK is due to leave the EU on 29th March 2019, at 12 pm UK time, and it will then become a third country not member of the EU. EU legislations will cease to apply in the UK. Currently, UK and EU are still negotiating a Withdrawal Agreement.

 

Both the European Commission and the United Kingdom make available on their websites the latest news about the on-going negotiations and information about the worst case scenario, ‘no deal’ Brexit scenario.

 

On 19th February 2019, the European Commission published: “Political declaration setting out the framework for the future relationship between the European Union and the United Kingdom (2019/C 66 I/02)”.

 

If you are a manufacturer, importer, distributor, responsible person, retailer or consumer, it is important that you are aware of the possible ‘no deal’ Brexit scenario in which you may need to adopt different role and obligations from the current ones.

 

A brief summary has been included below for different sectors and how could the fact of not having an agreement between UK and EU affect them:

 

Cosmetics

 

With respect to cosmetics industry, the likely key difference between Brexit with a deal or no deal is the transition period. A deal will provide a transition period from 29 March 2019 to the end of December 2020.

 

A draft version of the UK Cosmetic Regulation was published in December 2018, The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (as per Schedule 34).

 

Amendment of Regulation (EC) No 1223/2009 and related amendments have now been laid in draft before Parliament, and will be reviewed by the UK Parliament in February 2019.

 

The Office for Product Safety and Standards (OPSS), which is part of the Department for Business, Energy and Industrial Strategy (BEIS), issued a letter highlighting the practical changes that cosmetic companies have to take into account in a ‘no deal’ Brexit scenario, in relation to the requirements stated in the draft UK Cosmetics Regulation Statutory Instrument.

 

Click to read the pdf [Beis no deal Brexit letter]

 

On other hand, in November 2018, the EU Commission published a Notice to stakeholders: Brexit – guidance to stakeholders on impact in the field of cosmetic products.

 

As a summary, the key aspects to be taken into account are:

 

Europe

UK

Responsible person is:

  • The manufacturer (or legal person established in the EU) for cosmetic products manufactured in the EU
  • The importer (or legal person established in the EU) for cosmetic products imported into the EU

The responsible person must be established in the EU.

The responsible persons can no longer establish themselves in the United Kingdom for products to be sold in EU. Therefore, if the manufacturer of the cosmetic product is established in the United Kingdom, a separate responsible person must be designated in an EEE Member State.

Responsible person is:

A responsible person must be established in UK.

Therefore, if the manufacturer of the cosmetic product is established in the EU and wants to sell to the UK market they must establish a separate responsible person within the UK.

CPNP notifications:

The responsible person shall notify a list of information relating to the cosmetic product to the Commission, through the Cosmetic Product Notification Portal (CPNP).

A UK-based responsible person can transfer an existing notification to the future EU-27 responsible person. This transfer in CPNP is only possible until the withdrawal date.

As of the withdrawal date, the former UK-based responsible person will no longer have access to the CPNP.

Secretary of State using the UK database:

Products already supplied on the EU market and notified on the EU CPNP before Exit day will have 90 days to notify the UK CPNP, a simplified process, with the following information:

  • the category of cosmetic product and its name
  • the name of the responsible person
  • the address at which the product information file is kept
  • contact details of a natural person to contact in case of emergency
  • The product frame formulation

New products being placed on the UK market after exit day will be required to make complete notifications to the Secretary of State using the UK database prior to placing the product on the market.

PRODUCT INFORMATION FILE (PIF)

It has to be made available at the address of the responsible person in the EU-27 and adapted in terms of the language requirements of the specific Member State.

PRODUCT INFORMATION FILE (PIF)

The responsible person must make the product information file readily accessible to a competent authority in an electronic or other format at the address notified.

The information contained in the product information file must be in English.

Labelling:

Cosmetic products manufactured in the United Kingdom and placed on the EU market will be a cosmetic product imported into the EU-27 and the country of origin will need to be specified.

Labelling:

The labelling must include the UK Responsible Person details (name and address) for that product. There will be a two-year transition period from exit to adapt labels, as long as the EU labelling requirements (to have the name and address of the EU responsible person) have been met.

 

Chemicals

 

The chemicals sector is the UK’s second biggest manufacturing industry and UK businesses currently hold 12,419 registrations (13%) with REACH.

 

A ‘no deal’ would mean that UK businesses that manufacture or import chemicals from the EU will have to register those chemicals to a new UK regulatory system.

 

UK REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) will replace EU REACH and will require businesses to demonstrate how a chemical can be safely used with minimal risk to human health or the environment.

 

The Health and Safety Executive (HSE) would act as the lead UK regulatory authority. HSE has available guidance on how to prepare if the UK leaves the EU in a “no deal” scenario for Chemicals substances (REACH), Classification Labelling and Packaging (CLP), biocidal products (BPR), Plant protection products (PPP), Persistent Organic Pollutants (POPs), Prior informed Consent regime for export and import of hazardous chemicals (PIC).

 

The Department for Environment, Food and Rural Affairs (Defra) has set the UK REACH plan for a ‘no deal’ Brexit scenario.  It has been running UK REACH-IT research sessions to help develop a fit-for-purpose system. Now it is working in other possible users (Downstream Users) that currently don’t have obligations to register substances but, may have obligations to register substances after Brexit date.  

 

The Regulatory Policy Committee (RPC) has also published its opinion  of the UK REACH plan.

 

On 19th December 2018, the UK Government published the update about ‘no deal’ technical notice on REACH.

 

The European Chemicals Agency (ECHA), responsible body implementing this framework in the EU, has a section in its website about BREXIT and how could a “no deal” scenario affect chemical companies.

 

On 13th February 2019, ECHA published a notice indicating that ECHA will open a ‘Brexit window’ in REACH-IT from 12 to 29 March to enable UK-based companies to make these changes and transfer their REACH registrations.

 

Key points are highlighted below:

 

EU companies

UK Companies

They need to make sure that there is an EU supplier with a valid REACH authorization for their substances and their uses.

They have to look for an EEA-based organization or Only Representative in Europe to transfer the registrations and the information about the substances they sell in Europe.

If an Only Representative is not appointed in UK, the EU-27/EEA importers will have to submit their own registrations.

UK companies with EU REACH registrations will have to provide basic information to UK REACH IT within 60 days of the UK leaving the EU. Companies will then have 2 years, from the UK leaving the EU, to provide the full data.

If a downstream user in one of the EU-27/EEA countries relies on REACH authorizations granted to a UK-based company, they need to make sure that there is another EU-27/EEA supplier with a valid authorization for their use.

UK downstream users importing chemicals from an EEA country will become importers and have registration obligations under UK REACH.

Companies based in the EU-27/EEA will also need to prepare for placing substances on the UK market after 29 March, which will be governed by UK law.

UK companies importing chemicals from EU that currently don’t hold an EU registration will have to follow a notification process before the UK leaves the EU. Companies will have to provide basic data on the chemicals within 180 days of the UK leaving the EU, instead of undertaking a full registration immediately. A full registration will be required at a later time.

They will be able to use the UK REACH IT system to transfer the basic information of the substances with REACH registration and registrations for new substances. 

They will be able to use the UK REACH IT system to transfer the basic information of the substances with REACH registration and registrations for new substances. 

If the European company sells to UK, the products must be classified, labelled and packaged according to CLP (UK) through its UK representative company and notify the classification to HSE.

Classify, label and package the substances and/or mixtures according to CLP (UK). Labels must be in English but other languages are also permitted. Notify to HSE the classification and labelling from exit day to sell them in UK market.

If the European company sells to UK, its UK representative must notify to UK’s national poison centre the hazardous mixtures or substances.

Submit information about hazardous mixtures placed on the market to the UK’s national poison centres – National Poisons Information Service (NPIS). From exit day, unless already submitted and no change has been made to the formulation.

Identify an importer in UK who will place substances/mixtures on the market.

Identify an importer in EU27/EEA Member State who will place substances/mixtures on the market.

Companies with new chemicals, that want to market them in the UK and Europe, will have to make two separate registrations for both EU and UK REACH. The data package required will be the same.

 

For more information, you can read the latest guidance on requirements for using chemicals after the UK leaves the EU by HSE.

 

Further guidance

 

 

Additional information

 

The UK Government and European Commission have made available a series of guidance documents with information on how to prepare if the UK leaves the EU with no deal. Below the list of the most recent documents: