The UK left the EU on 31 January 2020 with a Withdrawal Agreement (deal). 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, which ended on 31 December 2020, although the UK is already officially outside the EU, EU legislation continued to apply in the UK. In practice, companies continued to operate during the transition period itself as in the past.
However, the transitional period has ended, and from 1 January 2021 companies wishing to continue or start selling cosmetic products in the UK will now have to comply with regulation the UK Cosmetics Regulation (UKCR) which can be found on Annex 34 of the Product Safety and Metrology, etc. (Amendment, etc.) (EU Exit) Regulations 2019 Statutory Instrument (SI) and its amendments listed below:
“Extent & Meaning of the Market” - The Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 – SI – 676: The Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020. This SI ensures that the Product Safety and Metrology is only applicable in GB, according to the provisions under the NI Protocol. This means that the obligations for cosmetics under Schedule 34 of the SI is only applicable to GB and not NI.
“Exit Day” - The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020 (currently being sifted): The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020. This SI changes references to “Exit day” to “Implementation Period completion day”, which is 31 December 2020.
“OSI – Other Separation Issues” – The Product Safety and Metrology etc. (EU Withdrawal and EEA EFTA Separation Agreements) (EU Exit) Regulations 2020 SI, which was laid on 17 August 2020.
Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 - to adapt the original text to the end of the Implementation Period and take consideration of the provisions within the Northern Ireland (NI) Protocol, in line with the Withdrawal Agreement.
On 17 November 2020, the UK Government issued several guidance documents related to the Statutory Instrument (SI) on Product Safety and Metrology, in which cosmetics are also included in Annex 34.
The specific guideline on all regulatory requirements for products that are sold on the UK market can be found here.
The UKCR entered into force on 1 January 2021 and will apply to Great Britain (England, Wales and Scotland); Northern Ireland will follow EU regulations under the NI Protocol to the Withdrawal Agreement under which the UK left the EU.
Although the UKCR is very pro-active with the EU Cosmetics Regulation, we have listed the main 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. The UK notification database was launched 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.
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.
Articles 25 and 26 deal with non-compliance.
Pharmilab has opened offices in London and is already helping many of its customers to maintain their operations in the UK market.
If you have any questions or would like more information please do not hesitate to contact us.