UK EU Cosmetics Regulations 2019 PDF

Legislation refresher and cosmetovigilance European Cosmetics Regulation (Regulation (EC) No. 1223/2009) GB Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019)...

Legislation refresher and cosmetovigilance European Cosmetics Regulation (Regulation (EC) No. 1223/2009) GB Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019) (Applicable in England, Scotland and Wales) Mignon Cristofoli Based on lectures of Caroline Searing The Northern Ireland Protocol The Northern Ireland protocol Products sold in GB (England, Scotland The British Isles and Wales) must comply with UK laws Products sold in NI must comply with EU THE UNITED KINGDOM law. IRELAND Until the Windsor Framework signed Republic of Ireland Northern Ireland GREAT BRITAIN: 27th Feb 2023, products from GB England Scotland received into NI were treated as Wales imports. Now they will go through a “green channel” if for use in UK (incl NI) only Qualifying products from NI (in general those made in NI) and subject to EU law can be sold in GB Background: Cosmetics Regulation (EC) No. 1223/2009 Implemented 11 July 2009 Came into force in full in the UK in 2013 Applied to all European member states The UK left the EU on 31 January 2020, and followed a transition period until 31 December 2020. From 1 January 2021: UK cosmetics legislation: Modified version of 1223/2009 in Schedule 34 of the Product Safety and Metrology etc (Amendment etc) (EU exit) Regulations 2019 Basically same as 1223/2009 but with some modifications Copies of both pieces of legislation can viewed at the URLs given below: https://www.legislation.gov.uk/ukdsi/2019/9780111176368/schedule/34 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF Key points The UK and EU cosmetic legislation remain very similar Main changes UK removed anything relating to freedom of movement and co-operation between member states In terms of the person to whom things should be reported. In UK no longer EU Commission, but the Secretary of State. Office dealing with this is the Office for product safety and standards (OPSS) which is part of the Department for Business and Trade. Main purpose of the legislation: safety and to facilitate trade Legislation describes the PIF that is required for each product before it is placed on the market UK Legislation for EU- based companies selling in GB Responsible person based in the UK (presented on label) UK has a portal called Submit Cosmetic Product Notification SCPN replaces EU CPNP Product information file, PIF must be available in English language Safety assessor qualified in pharmacy, toxicology, medicine or recognized as equivalent by the Secretary of State UKCA compliance mark, replaces the reversed epsilon mark (aerosols) Businesses who bring cosmetic products into GB from an EU Member State will become ‘importers’ instead of distributors Product Information File (PIF) The Responsible Person is required to ensure that each cosmetic product placed on the market has a complete PIF The PIF contains all of the mandatory information on the product Includes the Cosmetic Product Safety Report (CPSR) Contents of PIF described in Article 11: 2 a – e a. Product description b. Cosmetic product safety report Part A: Cosmetic Product Safety Information Part B: Cosmetic Product Safety Assessment c. Method of manufacture and statement of GMP d. Proof of effect (claim substantiation) e. Animal testing data MUST BE KEPT FOR 10 YEARS after last batch is placed on the market https://www.cosmeticseurope.eu/files/2214/7945/7676/Updated_Cosmetics_Europe_PIF_ Guidelines_-_2015_-_Update.pdf  Safety assessment (Article 10) Article 10.1: to show that a cosmetic product complies with article 3 (i.e. it is safe) “the responsible person (RP) shall ensure, prior to placement on the market, that the product has undergone a safety assessment, and that a cosmetic product safety report (CPSR) is set up in accordance with Annex 1” The RP shall ensure that: (a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment; (b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; (c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.  Cosmetovigilance and dealing with adverse reactions Safety data generated subsequent to the placing of the product on the market Adapted from CTPA Cosmetovigilance Webinar 2022 20 20  What is Cosmetovigilance? Cosmetics Europe Definition: Cosmetovigilance is defined as the collection, evaluation and monitoring of spontaneous reports of undesirable effects (including SUE) observed during or after normal or reasonably foreseeable use of a cosmetic product. Cosmetics Europe, (2016) Guidelines on the management of undesirable effects and reporting of serious undesirable effects in the European Union 25 Strictly Private & Confidential Cosmetovigilance Or to put it more simply: Cosmetovigilance is the monitoring of adverse reactions to cosmetic products when they are used by consumers It’s a legal obligation of RP and Distributors under Article 23 of the regulations It’s a useful tool for identifying any safety concerns about a product on the market Statutory guidance (UK) UK Cosmetics Regulation Cosmetic Products Enforcement Regulations 2013: Great Britain Last updated May 23 Available online from: https://www.gov.uk/government/publications/cosmetic-products- enforcement-regulations-2013/regulation-20091223-and-the- cosmetic-products-enforcement-regulations-2013-great-britain Main change SUEs must be notified to OPSS via specific (UK) forms Definition of anadverse effect Definitions given in Article 2 of the EU and UK regulations Undesirable effect: [CPSR only] ‘an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product’ Serious undesirable effect: [REPORT & CPSR] ‘an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital abnormalities or an immediate vital risk or death’ MISUSE IS NOT INCLUDED IN THE DEFINITION OF A UE /SUE 12 Company responsibilities for cosmetovigilance 1) Correct interpretation of alleged undesirable effects (complaint) 2) To collect information and to carry out a causality assessment - i.e. there is a relationship between the product/ ingredients and a reaction 3) UE and SUE information to be included in the CPSR 4) PIF to be updated 4) To report all SUEs to the UK authorities OPSS (or to relevant authorities of a member state if in the EU) 5) Notification should take place ‘without delay’. This is accepted in the UK to mean within 30 calendar days from when anyone in the company is informed of a possible SUE (EU 20 days). Article 21 - information of number of UEs and SUEs in relation to a particular product to be made available to public on request Simple cosmetovigilance process Receive information of adverse effect Notify authorities (UK: OPSS) Collect information (UK 30, EU 20 days) and determine Serious causality Undesirable Effect Update CPSR and PIF Causality Proved Update CPSR and Undesirable Effect PIF Dealing withan adverse reaction Company will carry out a causality assessment on a case-by-case basis to determine the probability that the cosmetic product used is responsible for a genuine undesirable effect and therefore attributable to the adverse reaction. Company must have clear procedures for maintaining records relating to each case, and the causality assessment Subject to GDPR (general data protection regulations) must have consent to keep If no causality => don’t include in PIF or submit data Collecting information from the consumer: example of a questionnaire provided by Cosmetics Europe: Type of product Usage instructions History of use Site of application and reaction Symptoms and signs of reaction Timing of reaction Medical history & medication Previous allergies Occupation Obligations relating to communication of SUEs Article 23 (UK): Communication of SUEs: the RP (and distributors) shall without delay notify the following to the Secretary of State (UK) - actually the OPSS/ competent authority of member state (EU): a) all SUEs which are known to the RP or the distributor or which may reasonably be expected to be known to that RP (and/or distributor) b) the name of the cosmetic product concerned, enabling its specific identification; c) the corrective measures taken by the RP (or distributor), if any” Forms used for reporting SUEs to the UK authorities can be found at https://www.gov.uk/government/publications/cosmetic-products-reporting- sues Completed SUE report forms should be returned to [email protected] Platform of European Market Surveillance Authorities in Cosmetics (PEMSAC) guidance and reporting forms (Forms A, B and C). http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance_en  SUEs Reporting to the competent authority Information required: i.e what are you reporting? 1. An identifiable reporter - Healthcare professional or consumer (WHO reported, don’t give personal data to authorities) 2. Description of the reaction (WHAT happened) 3. Date of event (WHEN it happened plus any sequence of events) 4. An identified cosmetic product description (enough to enable product specific identification e.g. brand, name, batch code)  UK Product Safety Database The Office for Product Safety and Standards (OPSS) has created the UK Product Safety Database, where reports of products placed on the UK market posing a risk to the health and safety of consumers are published. Record information about supply chains, evidence, and corrective actions Market surveillance authorities (Trading Standards in GB) report and share information relating to unsafe and non-compliant products by creating 'cases'. It replaces the EU databases RAPEX and ICSMS (Information and Communication System for Market Surveillance). https://www.product-safety-database.service.gov.uk/, For further information regarding the product safety database, please see the following guidance: https://www.gov.uk/guidance/notification-of-unsafe-and-noncompliant-products-and-cosmetics Possible outcomes of an Adverse reaction Completely withdraw OR recall the product Dependant on severity Product could be faulty Quality issue Remove the product from sale Product could have a danger to health? Product is not compliant with legislation Corrective action not always required - doesn’t mean product is unsafe. It does need to go through the 20 process to determine whether corrective action is required Final summary of cosmetovigilance (SUEs) Corrective Report SUE Assessed action (if required) CTPA : Cosmetovigilance https://www.ctpa.org.uk/cosmetovigilance?pageid=376 SUE reporting forms https://www.gov.uk/government/publications/cosmetic-products-reporting-sues Communication of SUEs Europe https://single-market-economy.ec.europa.eu/sectors/cosmetics/market-surveillance_en Guidance on cosmetics regulations UK https://www.gov.uk/guidance/making-cosmetic-products-available-to-consumers-in-great-britain OPSS https://www.gov.uk/government/organisations/office-for-product-safety-and-standards Patch testing guidelines (CTPA) https://www.ctpa.org.uk/member-resources-publications