Compliance with the European Cosmetics Products Regulation (EC) - - PowerPoint PPT Presentation

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Compliance with the European Cosmetics Products Regulation (EC) - - PowerPoint PPT Presentation

Jan 12, 2024 209 likes •989 views

Compliance with the European Cosmetics Products Regulation (EC) 1223/2009 Dr. Annelie Struessmann, CONUSBAT 1 Areas covered: The Recast Roles & Responsibilities in the Supply Chain Product Information File (PIF) Safety

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  • Dr. Annelie Struessmann, CONUSBAT

Compliance with the European Cosmetics

Products Regulation (EC) 1223/2009

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Areas covered:

  • The Recast
  • Roles & Responsibilities in the Supply Chain
  • Product Information File (PIF)
  • Safety Assessment
  • Criteria for Claims
  • Animal Testing Ban
  • Cosmetovigilence
  • Substance Regulations
  • Product Labeling
  • Borderline Legislation /e-Commerce

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Regulation (EC) 1223/2009 on Cosmetics Products

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The European Union – an Economic & Political Partnership

> 500 Million People 28 Member States 23 Official Languages

The Recast and its Legislative Environment

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The Recast and its Legislative Environment

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Old European Cosmetics Legislation: DIRECTIVE 76/768/EEC

Main Drivers for the Amendment

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Recasting = Simplification of the EU Cosmetics Legislation

Main Drivers for the Amendment

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Regulation (EC) 1223/2009 - Implementation Timelines

Main Drivers for the Amendment

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The Recast

Main Drivers for the Amendment

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Loose Ends

Source: CE

Main Drivers for the Amendment

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The Recast – further National Requirements

Main Drivers for the Amendment

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Regulation’s language versions across the EU are not correct – and the mistakes are not consistent Creates confusion in the EU and beyond (!)

Main Drivers for the Amendment

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Key Results for the Recast

Areas of Revision

Key Outcome - Areas of New Contents & Provisions

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Roles & Responsibilities in the Supply Chain

Roles & Responsibilities in the Supply Chain

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Allocation of Responsibility for Product Safety

Roles & Responsibilities in the Supply Chain

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  • Reg. (EC) 1223/2009 - Roles of Actors in the Supply Chain

Roles & Responsibilities in the Supply Chain

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Specific Distributor Obligations

Roles & Responsibilities in the Supply Chain

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Obligations of the Responsible Person

Roles & Responsibilities in the Supply Chain

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RP Location

Roles & Responsibilities in the Supply Chain

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Product Information File

PIF & Cosmetic Product Safety Report

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Product Information File

PIF & Cosmetic Product Safety Report

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Product Information File

PIF & Cosmetic Product Safety Report

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PIF & Cosmetic Product Safety Report

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Annex I: Cosmetic Product Safety Report

PIF & Cosmetic Product Safety Report

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Annex I: Cosmetic Product Safety Report

PIF & Cosmetic Product Safety Report

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Safety Assessor Qualification

Art 10(2) A person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course

  • f theoretical and practical study in pharmacy, toxicology,

medicine or a similar discipline, or a course recognised as equivalent by a Member State.

PIF & Cosmetic Product Safety Report

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Cosmetic Product Safety Report

PIF & Cosmetic Product Safety Report

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27 8th Revision

Cosmetic Product Safety Report

SCCS Safety

PIF & Cosmetic Product Safety Report

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SCCS: http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm

Cosmetic Product Safety Report

PIF & Cosmetic Product Safety Report

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Product Information File

PIF & Cosmetic Product Safety Report

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Article 20/CPR: Claims

  • 1. In the labelling, making available on the market and

advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

  • 2. The Commission shall, in cooperation with Member States,

establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use

  • f a claim.

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EU Cosmetics Regulation – Part 8: Criteria for Claims

Criteria for Claims

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Criteria for Claims

Criteria for Claims

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Regulation (EU) No 655/2013 on Criteria for Claims

  • 1. Legal compliance
  • 2. Truthfulness
  • 3. Evidential support
  • 4. Honesty
  • 5. Fairness
  • 6. Informed decision-making

Criteria for Claims

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Criteria for Claims

  • 1. Legal compliance

(1) Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed. (2) The acceptability of a claim shall be based on the perception of the average end user

  • f a cosmetic product, who is reasonably well-informed and reasonably observant

and circumspect, taking into account social, cultural and linguistic factors in the market in question. (3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed. Criteria for Claims

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http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/guide_reg_claims_en.pdf

Criteria for Claims

Criteria for Claims

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Product Information File

PIF & Cosmetic Product Safety Report

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Animal Testing Ban

Animal Testing Ban

Since March 2013, it is prohibited in the EU

  • To perform animal testing in the EU in order to meet the

requirements of the Cosmetics Regulation on finished products and on ingredients and combinations of ingredients

  • The sales of cosmetic products when either the final

formulation or an ingredient has been tested on animals – in the EU or outside of the EU – in order to meet the requirements of the Cosmetics Regulation

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Animal Testing Ban – Article 18/CPR

Animal Testing Ban

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Source:

COMMUNICATION COM(2013) 135 final, Brussels, 11.3.2013 http://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm In preparation: Guidance on Documentation in the Product Information File in relation to Article 18 (CPR)

Animal Testing Ban

Animal Testing Ban

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www.mentorhealth.com

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Animal Testing Ban

Source: CE

Tracking System for Alternative Test Methods Review:

http://tsar.jrc.ec.europa.eu/index.php?endpoint=3&method=5

Status for Animal Test Alternatives - 2014

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www.mentorhealth.com

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Research for Animal Test Alternatives

Animal Testing Ban

Source: CE Source: CE

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www.mentorhealth.com

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Test Method Acceptance Process

Animal Testing Ban

Source: CE Source: CE

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Roadmap for Alternatives to Animal Tests

Animal Testing Ban

Source: Cosmetics Europe

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www.mentorhealth.com

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Animal Testing Ban

Source: CE

Alternatives to Animal Testing

  • in-vitro, in-silico, in-chemica methods
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www.mentorhealth.com

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Animal Testing Ban

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Summary: PIF & Cosmetic Product Safety Report

PIF & Cosmetic Product Safety Report

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Product Information File - Article 11

PIF & Cosmetic Product Safety Report

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Cosmetic Product Notification Portal - CPNP

Notification

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Notification under the new Cosmetics Product Regulation

Notification

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49 Source: CE http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm

In-market Control

Cosmetovigilence

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Cosmetovigilence

–Serious undesirable events (SUE) – definition & reporting –PIF Documentation –Access to information for the public

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Cosmetovigilence

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Communication of Serious Undesirable Effects

Cosmetovigilence

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SUEs

Cosmetovigilence

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Communication of Serious Undesirable Effects

http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm

July 2013* *

Cosmetovigilence

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SUEs

Cosmetovigilence

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Non-Compliance

Cosmetovigilence

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Substance Regulations

Substances Regulations

  • The

Dual Approach towards Cosmetic Ingredients’ Safety in Use:

Safety assessment performed by a scientific committee

  • f the EU Commission.

Individual safety assessment which has to be performed by product manufacturers on those ingredients with no regulatory restrictions imposed.

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  • The Dual Approach towards Cosmetic Ingredients’ Safety in Use:

Source –

  • modif. graph:

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DG SANCO to became DG Santé in 2015

Substance Regulations

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Substance Regulations

  • DG SANCO

DG SANCO to became DG Santé in 2015

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  • The Law

Annexes II, III, IV, V, VI

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Substance Regulations

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Substances Regulations

Substance Regulations

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  • The Dual Approach towards Cosmetic Ingredients’ Safety in Use:

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DG SANCO to became DG Santé in 2015

Substance Regulations

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www.vectortemplates.com

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Substance Regulations

  • The Individual Safety Assessment

Annex I: Cosmetic Product Safety Report

Part A – Cosmetic Product Safety Information

  • Quantitative and qualitative composition of the product
  • Physical/chemical characteristics and stability of the cosmetic product
  • Microbiological quality
  • Impurities, traces, information about the packaging material
  • Normal and reasonably foreseeable use
  • Exposure to the cosmetic product
  • Exposure to the substances
  • Toxicological profile of the substances
  • Undesirable effects and serious undesirable effects
  • (Other relevant) Information on the cosmetic product

Part B – Cosmetic Product Safety Assessment

  • Assessment conclusion
  • Labelled warnings and instructions of use
  • Reasoning (incl. Margin of Safety [MoS], specific assessment for products for children < 3 and for

external intimate hygiene, possible interactions of ingredients, impact of stability on safety)

  • Assessor’s credentials and approval of part B
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  • Summary on Substances’ Evaluation

Responsibility for the safety in use lies with the cosmetic product manufactures. A large number of ingredients are regulated in 5 Annexes to the Cosmetic Product Regulation, however, the majority of ingredients is free to use. The approach towards evaluation of the ingredients safety is a dual approach - regulated substances are evaluated by an expert panel at governmental level, non regulated substances need to be assessed by an expert of the cosmetic product manufacturer.

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Substance Regulations

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Substance Specific Requirements

Substance Regulations

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*now Regulation (EC) 1223/2009

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Substance Regulations

REACH - Preamble 13

This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC* of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC* should take place with regard to the uses of those substances in cosmetics.

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Agenda – Day 2

Nanomaterials, CMRs, Hair Colorants

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Substance Regulations

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Substance Specific Requirements

Substance Regulations

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Substance Regulations

Substance Specific Requirements

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Substance Specific Requirements

  • Article 19

Substance Regulations

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Substance Specific Requirements

http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_142.pdf

Substance Regulations

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Substance Specific Requirements

Substance Regulations

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Substance Specific Requirements

Substance Regulations

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Product Labeling

Product Labeling

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Label source: soilassociation.org

Article.19 (1): Labelling

(a) the name or registered name and the address of the responsible person (b) the nominal content at the time of packaging (c) date of minimum durability or for cosmetic products with a minimum durability of more than 30 months the period of time after opening (d) particular precautions to be observed in use (e) the batch number (f) the function (g) a list of ingredients

Product Labeling

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Borderline Legislation

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Guidance:

MANUAL ON THE SCOPE OF APPLICATION OF THE COSMETICS REGULATION (EC) NO 1223/2009 (ART. 2(1)(A)) - VERSION 1.0 (NOVEMBER 2013) http://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products/docs/manual_borderlines_ol_en.pdf

EU Commission – Pages on Cosmetics:

http://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products/index_en.htm http://ec.europa.eu/growth/sectors/cosmetics/index_en.htm

Borderline Legislation

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Summary

  • Responsibility for the safety in use lies with the cosmetic

product manufactures.

  • In-market control by Member State authorities.
  • Cosmetovigilence system with a central RP.
  • PIF: Key tool for safety and general legal compliance.
  • Label: Legal document for consumer information.
  • Dual approach towards evaluation of the ingredients safety.
  • Defined ingredients are regulated in 5 Annexes to the CPR.
  • The majority of ingredients is free to use but must be

individually assessed for their safety.

  • Further specific provisions exist for defined ingredient groups.
  • Animal Testing Ban fully implemented.
  • Central notification prior to marketing.
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  • Dr. Annelie Struessmann
  • Kruppstr. 18

D-52072 Aachen, Germany Tel: +49241 51857790 Skype: annelie.struessmann annelie.struessmann@conusbat.com www.conusbat.com

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