Brexit Public Advice

In this page companies and individuals in the cosmetic and personal care industry can access CTPA public advice on Brexit.  

The recording of the CTPA Brexit webinar held on 16 November 2020 is now available here

The following sections contain advice on each of these topics and clear information on which actions must be taken now to be ready for 1 January 2021.


Introduction

The UK left the EU on 31 January 2020 with a Withdrawal Agreement (deal); it is business as usual from 1 February 2020 until 31 December 2020.  Members can view online the Withdrawal Agreement (WA) and the Political Declaration for insights into the future relationship between the UK and the EU.  Northern Ireland will operate differently to Great Britain, under the provisions that are outlined in the NI Protocol within the WA.

 

During the transition period, while the UK is officially out of the EU, EU law remains applicable in the UK.  In practice, companies will continue to operate during the transition period itself as they have in the past; however, it is CTPA advice that this time shall be used to prepare for what is to come from 1 January 2021.


Negotiations

CTPA continues to input into the ongoing negotiations for a comprehensive Free Trade Agreement (FTA) with the EU, whilst also supporting the UK Government in shaping the future UK regulatory framework.   Before the start of the negotiations, both the UK and the EU issued their negotiation mandates, highlighting the key discussion points for the UK/EU future relationship.

CTPA published its position papers with the key negotiation arguments for the future cooperation between the UK and the EU and the proposals for the future UK regulatory frameworks for cosmetics.  The position papers were presented on 28 February to Government officials and are available here

Following the negotiations, the UK and the EU have also published their proposed draft legal texts for the FTA:

Companies may find useful reading this summary of both proposals issued by the House of Commons Library.  Of further interest, the House of Commons Library also published this report summarising the status of the EU/UK negotiations so far.  


Scenarios

On 12 June 2020, the second meeting of the Withdrawal Agreement Joint Committee was held by video conference.  The meeting was co-chaired by the UK Chancellor of the Duchy of Lancaster, The Rt Hon Michael Gove MP, and EU Commission Vice President, Maroš Šefčovič, and attended by delegations which included Member State representatives and the First Minister and deputy First Minister of the Northern Ireland Executive.  It is important to highlight that at the meeting the UK confirmed its decision not to extend the transition period. 

There are therefore two possible scenarios that can occur and which have different implications: one scenario sees the implementation of a Free Trade Agreement (FTA) which sets the terms of future trade between the UK and the EU; the other scenario would arise if an FTA is not agreed and the UK and the EU continue to trade under World Trade Organisation (WTO) rules.  

Without extension of the transition period, the timing for completing negotiations is very tight; however, it is still possible for the UK and the EU to agree on a ‘bare-bones’ FTA. 

 

Independent of the outcome of the negotiations, there are specific actions that companies must take now to prepare for the changes that will happen as of 1 January 2021.  These are explained in detail throughout CTPA Brexit advice.

CTPA also published two factsheets containing the key parts of its advice.  In particular:

  • CTPA Factsheet ‘Are You Ready?’ summarises the key changes that will become applicable under the future UK legislation as of 1 January 2021, highlighting the actions that companies must take now to ensure they are ready for the end of the Brexit transition period.
  • CTPA Factsheet ‘Advice for Small Businesses’ is targeted advice for those small businesses, including salons, small shops and distributors that are importing cosmetic products from the EU.  The article explains in a clear and simplified way how these companies will be impacted by Brexit as of 1 January 2021 and what they should do to ensure compliance.

 


Tariffs and Rules of Origin

The UK and the EU are currently negotiating with the objective of 0% tariffs for all goods.  If a liberal FTA is agreed, trade between the UK and the EU will continue with 0% tariffs.

Should an FTA not be agreed, the UK and the EU would continue to trade under WTO rules.  This means that:

The UK Global Tariffs plan will also be applicable to any goods imported into the UK from other third countries with which the UK has no specific FTA, or which doesn’t have any additional considerations under WTO rules, such as developing countries or regions. 


Moving Goods Between the UK and the EU From 1 January 2021

Independent of the outcome of the Brexit negotiations, the borders between the UK and the EU will be operating from 1 January 2021.  The UK is no longer part of the EU and upon leaving the Single Market and the Customs Union, the free movement of goods will end.  It is really important to gain the understanding of how moving goods between the UK and the EU will change and act now to prepare.

Border Operating Model

On 13 July, the UK Government published the ‘Border Operating Model’, a guidance explaining how the EU/GB border will operate from 1 January 2021.  The guidance covers in detail the phased plan for imports into GB and exporting goods to the EU, whilst also covering roles and responsibilities for these tasks.

  • Both imports and exports into and from GB will require customs declarations.
  • Applicable tariffs under the UK Global Tariffs will have to be paid on goods imported into the UK (however, if an FTA with the EU will be in place, tariffs may not apply).
  • VAT will be levied on imports of goods from the EU, following the same rates and structures as are applied to Rest of the World imports.
  • Safety and security declarations may be needed for specific types of goods.
  • Additional requirements may apply only to specific goods (e.g. foodstuff, goods covered by International Convention CITES, excise goods).
Phased Border Control Plans

The UK Government border control plans will be implemented into three different stages until 1 July 2021, to give businesses more time to prepare.

For more information, please visit the UK Government website.

Actions to take – Imports into GB

There are clear actions that companies can take now to prepare to continue to trade with the EU as of 1 January 2021.  It is key for companies to prepare now, as these steps need to be taken independent of the outcome of the Brexit negotiations.  Further information can be found here

For full details, please consult the ‘Border Operating Model’ guidance.  The UK Government also published a simplified decision tree of all requirements and steps for importing goods into GB from the EU.

Cosmetic products imported into the UK will have to comply with the UK Cosmetics Regulation that will be issued before the end of the Brexit transition period.  For further help, please view the ‘Sell in the UK’ section of CTPA Brexit advice.

Actions to take – Exports to the EU from GB

Exporting procedures can be checked here and the UK Government also published a simplified decision tree for all requirements and steps for exporting goods from GB to the EU.  More information is also available in this communication from the EU Commission. 

Cosmetic products exported to the EU will have to comply with the EU Cosmetics Regulation 1223/2009.  For further help, please view the ‘Sell in the EU’ section of CTPA Brexit advice.

Moving goods into/out of/through Northern Ireland

The Withdrawal Agreement (WA) under which terms the UK left the EU on 31 January 2020 also includes a Protocol on Northern Ireland, providing the legal framework for trade in NI.  An explanatory note is available here.

Whilst some fine details of the procedures applicable for moving goods in/out/through Northern Ireland will depend on negotiations and agreement at the Joint Committee, there are basic legal terms already agreed as part of the NI Protocol and that will be part of future trade to/from/through NI.  More information is available here.

For regulatory compliance in NI, please view the ‘Regulation in NI’ section of CTPA Brexit advice. 


Goods on the market

Article 41 of the EU Withdrawal Agreement states that goods placed on the EU27 or UK markets before the end of the transition period may be further made available and circulate between the two markets until they reach the end consumer.  Proof of when the goods were placed on the market will be required.  For the definition of 'placing on the market' and 'making available on the market', please consult the Blue Guide


Sell in the UK

With regards to future UK legislation, the EU Withdrawal Act provides for EU law to be retained in the UK post-Brexit, by adaptation into UK law.  The EU Withdrawal Agreement Bill legislates to allow for changes to be introduced while transposing EU law into UK law to correct deficiencies.  This means that in the short term (at the end of the transition period) UK law will be constituted of retained EU law, therefore a mirror image of EU law, with some differences in some mechanisms that depend on the UK Government structure and on the outcome of the negotiations.

UK Cosmetics Regulation

The Statutory Instrument (SI) Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which includes the UK Cosmetics Regulation within Schedule 34, was issued last year to provide a UK regulatory regime for non-food goods should the UK have left the EU without a Withdrawal Agreement (WA).  Therefore, this SI was initially in place for a ‘no deal’ Brexit.

On 2 July, the UK Government Department Office for Product Safety and Standards (OPSS) announced the entry into force of the same SI from 1 January 2021; we therefore have confirmation that the UK legislation that was published for a ‘no deal’ Brexit is not expected to change in the current context.

However, a series of SIs have already been published, or are scheduled to be published throughout the next few months to implement technical modifications and make the Product Safety and Metrology SI suitable to the context where the UK left the EU with a WA.  The 7th amendment will be the main amending SI for cosmetic products, which is due to be published and go into Parliamentary process on 14 October 2020.  Below is the list of amendments to the SI; this list will be kept up to date. 

Key Actions to Take Now

Companies wishing to continue to sell cosmetic products on the UK market from 1 January 2021 must take the below actions now.

  • Set up a UK Responsible Person (more information on the RP and the mandate is available here).
  • Update the product label (both primary and secondary packaging) with the UK RP name and address
    • As per Article 19 of the UK Cosmetics Regulation draft SI, products with an EU address, but no UK address, on pack can be made available on the UK market for 24 months after Exit day.
  • Update the product label with the country of origin, if the product is made outside of the UK
  • Prepare for the UK product notification. The UK will have its own UK notification database, which will be available from 1 January 2021.  UK RPs will need to open an account on the UK notification database.
    • Existing products à notifications from EU CPNP must be notified within 90 days from 1 January 2021.  To prepare for this, companies have to download the 'xml' files of their existing notifications under the EU CPNP.  The new UK notification database will support the upload of the 'xml' files.
    • New products à a brand new notification is needed on the UK notification database.
  • Translate the PIF in English, which must be made available to UK authorities at the UK RP address.
  • Confirm the qualifications of your safety assessor. The safety assessor qualification must be accepted in the UK.
  • Check your supply chain for changes to roles and responsibilities. Your current distributors will become importers under the future UK Cosmetics Regulation and they will automatically take on the roles of RP. You need to ensure that your distributors will have a mandate in place with your new UK RP, to ensure the responsibility for your products is under your appointed legal entity.
  • Plan for future changes in the compliance of product formulations. Ingredients restrictions/bans/assessments that have been published in the EU Official Journal up until 31 December 2020 will be automatically implemented into UK law. Assessment of ingredients published after 1 January 2021 will be carried out independently by the UK.

 

CTPA would like to emphasise the fact that current distributors bringing cosmetics into the UK market from the EU/EEA will become importers and their responsibilities will change. In line with the EU Cosmetics Regulation, the UK Cosmetics Regulation SI automatically considers importers as the RP. However, an importer may designate a person established in the UK as the RP by written mandate.  CTPA has also published specific advice for current distributors of cosmetic products between the UK and the EU. 

UK REACH

There will be a UK regulatory framework for chemicals based on EU retained law, however its practicalities and duplication requirements very much depend on the outcome of the negotiations.  Therefore, it is unclear how UK REACH will be affected by the negotiations.  Members will be aware that the ‘No deal’ Brexit UK REACH SI was adopted in March 2019; CTPA understands this is likely to form the basis of any future UK chemicals legislation.  Two amendments of the UK REACH SI were also published in 2019 to address some initial industry’s issues:

Under the UK REACH SI companies will have specific actions to take and may change their role vs EU REACH and therefore their obligations.  Of particular short-term importance, are the transitional provisions under the UK REACH SI as they apply to chemicals already registered under EU REACH, should companies want to continue to sell them on the UK market.  Updated guidance on the obligations was published by Defra on 1 September 2020 and it is summarised below.  The Health and Safety Executive (HSE) has also published guidance on how to prepare for UK REACH based on your role within the supply chain.

Registration holders

EU REACH registration holders based in the UK will need to provide preliminary information to the Health and Safety Executive (HSE) before 30 April 2021.  The full registration will need to be submitted according to the reviewed timelines as per the table further down this page, with a starting date of 28 October 2021.

Accordingly, EU REACH registration holders within the EU will need to extend their registrations to cover UK REACH via their UK-based affiliate or by appointing a UK-based Only Representative.

Downstream Users

Downstream users (DU), which include manufacturers or importers of finished cosmetic products, could have new obligations under UK REACH.  DUs are therefore encouraged to map their supply chain and understand their roles and responsibilities, and establish a dialogue with suppliers of raw materials and ingredients, leading to the below possible scenarios.

  • For chemicals which have been registered under UK REACH by their suppliers, DUs will maintain this role and will not have any additional obligations.
  • For those chemicals which have not been registered under UK REACH by their suppliers, DUs could become importers and would be taking on additional obligations under UK REACH.  A 300 day deadline has been given to complete a Downstream User Import Notification (DUIN) for these chemicals introduced into the UK market, until the 28 October 2021.  After this deadline, the full registration dossier will have to be presented within the timelines given in the table below.

Reviewed timelines

These timelines are applicable to EU REACH registrations which have been extended to UK REACH by their registration holders and for those registrations following the submission of a DUIN. In both cases, they take effect on the 28 October 2021.

The below decision tree helps visualise the considerations and actions that companies should take.

The negotiations surrounding access to the ECHA (European Chemicals Agency) database under EU REACH, which could negate the need for full data submission, will continue, and cooperation with regards to chemicals will still be sought under the future UK-EU relationship.  CTPA continues to work with the UK Government, Cosmetics Europe (CE) and the Chemical Industries Association (CIA) to push for cooperation between UK authorities and the European Chemicals Agency (ECHA) in respect of chemicals.  For more information, please download the CTPA Position paper on the chemicals regulatory framework, which highlights CTPA position as too how the UK and the EU could continue to cooperate specifically for chemicals, and how the UK future REACH Regulation might be implemented.

On 28 May 2020, the CIA and the European Chemical Industry Council (Cefic) published two joint position papers on Brexit and negotiations:

Key Actions to Take Now

While it is still uncertain whether there will be any collaboration between the UK and the EU in regard to chemicals, companies are advised to prepare for UK REACH by taking the below actions.

  • Map the chemicals within your cosmetic products that you are directly importing into the UK from the EU.
  • Are they above 1 tonne per legal entity per year? If yes, you will need to comply with the UK REACH requirements.
  • Are the suppliers of my raw materials going to ensure compliance with UK REACH?
    • If not, plan for the possibility of having to change your formulations.
  • For more information, please consult the CTPA Factsheet available for download in the above REACH section.

Registration of new chemicals placed on the UK market from 1 January 2021 must be carried out as required under Part 2 of the UK REACH SI. 


Sell in the EU Market

EU Cosmetics Regulation

During and following the transition period, the EU Cosmetic Products Regulation (CPR) will continue to apply to EU27 Member States, as is currently the case. UK companies wishing to continue to sell cosmetic products to the EU27 market will have to comply with the CPR. 

On 13 March 2020, the EU Commission updated its readiness notice for cosmetics to remind companies of the legal situation applicable as of the end of the transition period on 31 December 2020.  The document also explains provisions related to the Withdrawal Agreement and rules applicable to Northern Ireland.  The key points are highlighted below.

  • Companies wishing to continue to market cosmetic products in the EU market must set up a Responsible Person (RP) within one of the EU27 Member States.  The document also highlights the fact that importers of cosmetic products from the UK into the EU will automatically be considered as the RP (as stated under the Article 4(5) of the EU Cosmetics Regulation) and must therefore take appropriate measures or solutions. 
  • The new EU-based RP will have to transfer all existing notifications held by the current UK RP to its own new account in the Cosmetic Product Notification Portal (CPNP) before the end of the transition period.
  • The new EU-based RP will need to make the Product Information File (PIF) available at its address, in the language as required by the EU Member State competent authority.
  • The name and address of the new EU-based RP must be on the label of the cosmetic product, on both primary and secondary packaging. 
  • Check that the qualifications of the safety assessor are accepted in the EU Member State where the new RP is based.
  • Article 41 of the EU Withdrawal Agreement states that goods placed on the EU27 or UK markets before the end of the transition period may be further made available and circulate between the two markets until they reach the end consumer.  Proof of when the goods were placed on the market will be required.   The notice also explains which definition of ‘placing on the market’ applies, together with an example.
  • The NI Protocol provides for EU law to be applicable also in NI. For more information, please see the specific section on NI below.

EU REACH

EU REACH will continue to apply to EU27 Member States as is currently the case. UK companies wishing to continue to sell cosmetic products and chemicals to the EU27 market will have to comply with EU REACH. 

On 30 March, the EU Commission updated its technical notice on REACH to advise companies on how to prepare to ensure compliance with EU REACH at the end of the Brexit transition period on 31 December 2020.

The document reflects key actions that companies have to take if the future relationship between the UK and the EU will be solely based on the terms of the Withdrawal Agreement; the document also explains rules applicable to Northern Ireland.  The key points are highlighted below.

  • Registrations held by a UK-based registration holder must be transferred to an EU27-based entity before the end of the transition period.
  • EU-based Downstream Users (DU) using UK-registered substances must ensure that the registrant is planning to transfer the registrations to an EU27-based entity.  If this is not an option, the DU can re-arrange the supply chain to source EU-registered substances; or the DU can decide to register the substances under EU REACH as an importer.
  • A UK-based lead registrant of a joint submission group must transfer its role to an EU27-based lead registrant.
  • At the end of the transition period, the Protocol on Ireland-Northern Ireland applies.  The NI Protocol makes certain provisions of which EU law applies in NI.  The NI Protocol provides that Regulation (EC) No 1907/2006 applies to NI.
    • A substance placed on the NI market above 1 tonne per year has to be registered under EU REACH; this applies to substances manufactured in NI or imported into NI from GB.
    • A substance placed on the market in NI and then shipped to the EU is not an imported substance in the EU, as it would be already registered under EU REACH.  A UK registrant established in NI need not transfer the registration to a manufacturer or importer in the EU.
    • An Only Representative established in NI will be considered to be an Only Representative in the EU.
Key Actions to Take Now

Map the chemicals within your cosmetic products that you are importing into the EU.

  • Are they above 1 tonne per legal entity per year?
  • If yes, where is the registration holder of the chemical based (EU or UK)?
  • Is the supplier of my raw materials going to ensure compliance with EU REACH? 

Regulations in Northern Ireland

The EU regulations listed in Annex II of the NI Protocol will continue to apply to NI, meaning that NI will still follow EU rules for the given legislations.  The EU Cosmetics Regulation, the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation, the Classification, Labelling and Packaging (CLP) Regulation are listed in Annex II of the NI Protocol, meaning that they will continue to apply to cosmetic products or their ingredients manufactured and sold in NI.   

The Office for Product Safety and Standards (OPSS) published guidance on complying with EU regulations for cosmetics in Northern Ireland.

UK RP in NI

Article 5A of the UK Cosmetics Regulation, which was introduced by the latest amendment Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020, gives the conditions for an NI-based importer or RP to be recognised also in the UK.


Denatured alcohol

According to the HMRC’s Excise Notice 64, denatured alcohol contained in certain goods (such as cosmetics, perfumes, etc.) imported into the UK from third countries is currently exempt from excise duty.

The HMRC confirmed that Excise Notice 64 on the import into the UK of alcohol from third countries will automatically apply to goods coming from the EU as of the end of the Brexit transition period.  This only applies to finished products and not raw materials. 

  • Imported denatured alcohol (as a raw material) used to make cosmetics (and other goods) needs to meet one of the UK denaturation methods to be exempt from duty.  This is to provide equity for UK and non-UK suppliers of denatured alcohol.  Section 5 of the Finance Act exempts denatured alcohol from excise duty so long as it meets one of the UK’s prescribed denaturation method. 
  • Imported goods not for human consumption, including cosmetics/perfumes/etc., made with alcohol denatured with another country’s denaturation method will be exempt from excise duty.  This is provided for by section 11 of the Alcoholic Duties Act 1979.

In order to benefit from relieve of the excise duty when moving denatured alcohol from the UK into the EU market, the alcohol must be denatured with a method accepted in at least one EU Member State. 


CITES

On 2 July, the UK Government updated its advice on trading CITES-listed specimens through the UK from 1 January 2021.

The UK will continue to comply with the Convention on International Endangered Species of Wild Fauna and Flora (CITES), however trade routes may change from 1 January 2021.  The above linked advice contains a list of designated points of entry and exit for CITES species, information on how to move CITES specimens from the EU to the UK, how to import CITES specimens into the UK from third countries and how to transit CITES specimens through the UK to reach the EU market.

The UK Government has produced a leaflet, which includes a checklist for preparing for CITES after 1 January 2021. 


New Immigration Scheme

On 19 February 2020 the UK Government published a policy statement on the new UK immigration system, highlighting:

  • the scope of the points-based system;
  • salary and skills thresholds for skilled workers;
  • a route for highly-skilled workers;
  • reducing the overall number of lower-skilled workers;
  • the visa process;
  • crossing the UK border;
  • engagement and outreach;
  • Migration Advisory Committee analysis of a points-based system.

This system will be effective from 1 January 2021.  Further guidance on employing EU citizens in the UK is available here.  EU citizens living in the UK before 1 January 2021 must apply for the EU settlement scheme to continue living in the UK; the deadline for this is 30 June 2021.

 

UKCA Mark for Aerosols

In September 2020 the Office for Product Safety and Standards (OPSS), a sub-department of the Department for Business, Energy and Industrial Strategy (BEIS), published updated guidance on the applicability of the UKCA mark, as substitute for the CE mark that will be in place after the end of the transition period, on the 1 January 2021.  While the applicability of the UKCA mark had been established for products that currently have the CE mark, the guidance states that “The UKCA marking will apply to most goods currently subject to the CE marking. It will also apply to aerosol products.”.

CTPA and the British Aerosol Manufacturers Association (BAMA) requested further clarification to OPSS and BEIS, with consideration regarding the CE mark currently not being applicable to all aerosols, but only to those aerosols that are classed as products for which the CE mark is mandatory. 

However, Schedule 13 of the Product Safety and Metrology (UK Aerosols Regulation) within its latest amendments Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 provides for the UKCA mark to be added to all aerosol products; this will include cosmetic aerosols.

The new requirements which will come into force following the end of the transition period are as follows:

  • after 31 December 2020 aerosols sold in GB can carry either the reverse epsilon (З) or the UKCA mark until 31st December 2021;
  • after 31 December 2021 all aerosols sold in GB must carry the UKCA mark. This mark can be applied as a sticker until 31st December 2022, if this is easier for marketers;
  • after 31 December 2020 aerosols sold in Northern Ireland (NI) must continue to carry the reverse epsilon (З) (as NI follows EU regulations), so after 31st December 2021 aerosols sold in both GB and NI must carry both the UKCA and reverse epsilon (З) mark to show conformity.

The conformity regime detailed in the GB Statutory Instrument is identical to the self-certification system currently required under the EU Aerosol Dispenser Directive (i.e. no third-party/conformity assessment verification is needed).

We understand that the reverse epsilon (З) will not be prohibited on aerosols sold in GB, however they will have no significance under the UK framework. 

 

UK Cosmetics Regulation

The UK Cosmetics Regulation (UKCR) is found within Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 Statutory Instrument (SI) and its amendments listed below:

On 17 November 2020, the UK Government issued several guidance documents related to the Product Safety and Metrology Statutory Instrument (SI), in which cosmetics are also included within Schedule 34.  The cosmetic specific guidance can be found here, and gives a thorough overview of the regulatory requirements applicable to cosmetic products sold in the GB market as of 1 January 2021. 

The UKCR comes into force on 1 January 2021 and it will be applicable to Great Britain (England, Wales and Scotland); Northern Ireland will follow EU Regulations according to the NI Protocol of the Withdrawal Agreement under which the UK left the EU.

The UKCR is in principles a replica of the EU Cosmetics Regulation.  The below highlights the key similarities and requirements, extrapolated from the legal text.

  • The UK Cosmetics Regulation applies to all cosmetic products placed on the GB market. It therefore covers products sold physically in shops and online.
  • Article 2 of the UKCR gives the definition of cosmetic product: “Cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.” From a borderline point of view, there is no change to what is defined as a cosmetic product in the UK.  Furthermore, the MHRA Guidance Note 8 is already a guide from UK authorities and remains unchanged.
  • Articles 3 and 10 of the UKCR cover safety and safety assessment requirements, which remain unchanged from current ones.
  • Articles 4 and 5 of the UKCR cover the concept of the Responsible Person and its obligations, which remain unchanged from current ones. 
  • Article 6 of the UKCR lists the responsibilities for distributors, which also remain unchanged. 
  • Article 11 of the UKCR covers the Product Information File (PIF).  A PIF is required for cosmetic products placed on the UK market, which must be made available to UK authorities at the RP address. The PIF must be in English.
  • Article 13 covers notification requirements. 

    Transitional provisions for products placed on the market before 1 January 2021 apply; please visit the section ‘UK Preparedness Actions’ for more information.  The UK notification database will launch on 1 January 2021.   

  • Article 18 of the UKCR covers the animal testing ban. The animal testing ban is maintained under UK Cosmetics Regulation for both finished cosmetic products and cosmetic ingredients.  The ban does not prevent the use of historic animal testing data in order to meet the requirements of this Regulation.
  • Article 19 of the UKCR covers the labelling requirements for cosmetic products.  Transitional provisions for products placed on the market before 1 January 2021 apply.
  • Article 20 of the UKCR covers claims.  Compliance with Commission Regulation (EU) No 655/2013 on the Common Criteria for Cosmetic Claims is mandatory.  It is worth noting that the UK advertising rules remain unchanged.
  • Articles 14, 15, 16, 30 and 31 cover requirements for ingredients, CMRs and nanomaterials.
  • Articles 22 and 23 cover cosmetovigilance and reporting of serious undesirable effects. Details of the process are being implemented by the UK Government, in collaboration with CTPA.
  • Articles 25 and 26 deal with non-compliance. 

UK REACH

The UK Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation is found within this Statutory Instrument and its amendments as below:

UK REACH comes into force on 1 January 2021 and it will be applicable to Great Britain (England, Wales and Scotland); Northern Ireland will follow EU Regulations according to the NI Protocol of the Withdrawal Agreement under which the UK left the EU.

This framework follows the same principles and standards as EU REACH, in particular:

  • no data, no market;
  • registration obligations for chemicals manufactured or imported into GB >1 tonne/year per legal entity;
  • it doesn’t apply to finished cosmetic products, but it applies to cosmetic ingredients.

The Health and Safety Executive (HSE) takes on the role of the European Chemicals Agency (ECHA).

The UK REACH SI gives provisions for substances not currently registered under EU REACH or imported outside of the UK.

Transitional provisions apply to substances already registered under EU REACH. 

Further guidance on UK REACH obligations depending on the company’s role, and on whether the substance is already registered under EU REACH or not, is available on the HSE website.

Requirements for NI businesses

A business based in NI (a manufacturer or importer of a chemical) who is a registrant or downstream user of a chemical registered under EU, and the chemical is a qualified NI good, can submit a Northern Ireland Notification directly to the HSE, without the need to appoint a UK-based Only Representative.  In this scenario, the GB business importing that chemical into the GB market, would be regarded as a downstream user and not as an importer.  More details is available on the HSE guidance both for the NI business and the GB downstream user of a NI qualified good.