The safety assessor courses in Germany - LIAA · data on any animal testing The safety assessor ... • Individual fields can remain free from ... experience for all safety assessors

The safety assessor courses in Germany

Birgit Huber

29 May 2012, Riga

Legal Basis

EU:

• EC-Cosmetics Directive or

• EC-Cosmetics Regulation

29 May 2012, RigaThe safety assessor courses in Germany 2

What is a 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;

Art. 2 Abs. 1 a. EC-Cosmetics Regulation


Requirements on safety (Art.3 EC-Cosmetics Regulation)

A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:

(a) presentation including conformity with Directive 87/357/EEC;(b) labelling;(c) instructions for use and disposal;(d) any other indication or information provided by the responsible person defined in Article 4.

The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.


Product information file (PIF) (Art. 11)

• For each cosmetic product

• Storage 10 years after last placing on the market

in case of several addresses: PIF-address must be highlighted (Art. 19)

• Contents:

a description of the cosmetic product ;

a safety report for the cosmetic product (Art.10 (1));

a description of the manufacturing method and a statement on the compliance with cosmetic-GMP;

proof of the effect claimed for the cosmetic product where justified

data on any animal testing


Control of PIF

• Art. 11, Abs. 3: „The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.“– within 48 to 72 hours after prior notification

• The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State

• Background documentation is not concerned (data sheets, study reports, publications)


Safety assessment

EG-Regulation: New terms

1. Safety assessment

2. Safety information

3. Safety report


Art. 10 EC-Regulation

• In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I

Safety assessment = Safety report?


Safety assessment is part of safety report

• Annex I: Safety report for cosmetics not for cosmetic products

• … consists of:– Part A – Safety information about cosmetic

products (= data)

– Part B – Safety assessment of cosmetic products (= way)


Part A

• Part A describes the essential elements, not a fixed structure of the report, which means

• … all elements need to be addressed, but not necessarily in the same order or the same headings given in Annex I.

• All relevant endpoints need to be addressed, but not necessarily with a toxicological study.

• Individual fields can remain free from entries, but require an explanation.


Part B: Safety assessment

1. The reasoning of the safety assessment and the related conclusion to the data in Part A has to be documented in detail.

2. Description of the evaluation sequence, conclusion of the evaluation, justification for the conclusion.

3. Label warnings and instructions of use.

4. Qualification of safety assessors Transfer of responsibility for part B (Signature).


Conclusion

• Safety assessment requires a qualified and experienced safety assessor.– Annex I can‘t convey these skills and should not.

• Safety assessment for cosmetic products is no standardised procedure and requires decisions on a case-by-case basis– It is not tackling a check list!

• All information need to be assessed; decisions have to be taken on a solid scientific basis (WoE = „Weight of Evidence Approach“).


EU-Commission guidelines

• Comments on legislation, especially for SMEs, to fulfil the requirements of the Cosmetics regulation (EC). -> available in 2012

• … should not be regarded as

Simplification

Guidance for two-class-safety assessment

Schoolbook for safety assessment

• … not to replace advanced training!


Updating of the Safety report

• Safety assesment can relate only to specific formulation and presentation of a product.

• Reformulation of the cosmetic product, as well as changing of packaging (technical design/material) and presentation (label elements, claims, usage instructions and warnings) will usually lead to re- examination and possible update of the safety assessment.– This includes, changes in the data situation for substances

in use (regarding to the scientific knowledge).


Tasks and Qualifications of Safety assessors

Tasks of Safety assossors (1)• Preparation of the safety assessment in accordance

with legal requirements

• Examination of the raw material data

• Microbiological assessment

• Exposure assessment

• Examination of health claims

• Possible restrictions of concentration for individual substances

• Possible introduction of warnings

• Observation of the market and resulting measures if necessary


Tasks of Safety assossors (2)• Observation of scientific evaluations (SCCX, BfR)

and

• Recommendations (e.g. IKW, Cosmetics Europe, BfR, EU-Comission)

• … as well as the SCCS‘ Notes of Guidance

• Adaption of the safety assessment to new formulations

• Adaption of the safety assessment to new scientific evidence

• Literature: www.sicherheitsbewerter.info i. a. data sources for safety assessors


Competence required Art. 10 Abs. 2 KMVO

„… by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.”


Conclusion

• The legally agreed definition is a prerequisite to be able to prepare safety assessments. This does not suffice to fulfil the requirements …

• … but on a case-by-case basis further specific knowledge has to be taken into account, e. g. experimental and clinical toxicology, dermatology, cosmetics chemistry (including production process) and legislation for cometics

• There is a need for further training, to be kept informed about the state of the art of scientific research and technology,

• e. g. DGK/IKW advanced training: www.sicherheitsbewerter.info/fortbildung.html


Appointment of the Safety assessor• It is necessary to ensure the safety assessors

independence and authority. For example: the safety assessor should only report to the management.

• The management has to ensure the following: the work of the safety assessor must not fail on inadequate equipment – organisationally, technically or in terms of staff.

• … and that the safety assessor has all necessary resources at his disposal to fulfil his task. Care should be taken to give access to all the information needed.


Appointment of the Safety assessor

• Important, applies especially to external safety assessors :

– Involve the safety assessor at an early stage, ideally throughout the product development!

– A safety assessment is not a one-off matter, it‘s alive – relevant information concerning the evaluated product should be available to the safety assessor after the product has been brought to the market.


The safety assessor courses in Germany

Background

Practical experience is needed

System developped in 1998

Members Advisory Committee on Cosmetic Products of the Federal Institute for Risk Assessment (BfR)

Scientists

BfR

Industry

German Society of Cosmetic Chemists (DGK)


Concept• 7 individual courses

• No qualification required for participation in courses

• Lasting two to three days

• An examination on the knowledge acquired in that course at the end of each course.

• Eighteen of 24 questions must be answered correctly.

• Participants receive a certificate for the respective course.

• Participants successfully completing all seven courses receive a certificate for the series.

• max. 35 attendees

• Costs about 700 €/course


The courses1. Exposure and Percutaneous Penetration

2. Topical Safety, Immunology and Sensitization

3. Metabolism, Kinetics and Structure-Activity Relationship

4. Carcinogenesis and Mutagenesis

5. General and Systemic Toxicology and Risk Assessment

6. Reproduction Toxicology

7. Microbiology

Regular exchange of persons responsible for courses once per year


www.sicherheitsbewerter.info


I – Exposure of cosmetic products/penetration

• Legal requirements

• Anatomy and physiology of the skin

• Guidelines of the SCCS

• Prinicples of safety evaluation of ingredients

• Basic information on exposure, eg. TTC

• Prinicples of safety evaluation of finished products


II – Dermatology: tolerance; immunology; sensitization

• Skin models and relevant in-vitro-Methods

• Comparison of in-vitro and in-vivo methods

• Toxic-irritative side-effects of cosmetics

• Allergic skin reactions

• Dermatological tolerance tests

• Hitlists of cosmetic relevant allergens

• Pre-clinical compatibility tests (LLNA)

• Cosmetic side-effects in dermatology

• Claims and Safety evaluation


III – Metabolism, kinetics and structure/effect relation

• Metabolism: basic information for the biotransformation of foreign substances in the body

• In-vivo/in-vitro-models/biomonitoring

• Mechanisms of structure/effect relation

• Evaluation of ingredients


IV – Carcinogenicity and Mutagenicity

•Basics of mutagenicity and carcinogenicity

•Test systems

•Test strategies


V – Toxicology including risk assessment

• Introduction of toxicology and mechanisms of toxic effects

• Methods in toxicology

• Testing of cumulative-systemic effects

• Intelligent test strategies/“Weight Of Evidence“

• Basics of toxicological risk assessment

• Information sources

• Risk assessment for products

• Intoxications with cosmetics


VI – Reproductive Toxicology

• Basics: Anatomie of the genital organs

• The hormonal control mechanisms of human procreation

• Basics of developmental biology of humans

• Overview on reproductive toxikologie, eg. test methods

• In vitro methods for the determination of damaging mechanism

• Endocrine Disruptors

• Structure/Effect-relationship

• Evaluation of cosmetic ingredients


VII – Microbiology

• Performance and interpretation of microbiological tests

• Test methods and evaluation of challenge tests

• Variants of challenge tests

• Microbiological purity criteria for cosmetics

• Relevance of scale up-Phase for microbiological product stability

• Mikroorganisms: contaminantion and health risks

• Risk evaluation and decisions in microbiology

• Documentation of safety relevant activities and decisions


Additional educational offers

• Two one-day events for exchange of experience for all safety assessors (lectures and practical exercise)

• Expert forum in the Internet for this Group

contains new information

updates on safety

• Will soon be available in English


The safety assessor certificates


Certificate for one course Certificate for all courses Certificate for safety assesorProof of fulfilment of qualification according to EU-Regulation

Thank you for your attention!

[email protected]

mailto:[email protected]

Documents

The safety assessor courses in Germany - LIAA · data on any animal testing The safety assessor ... • Individual fields can remain free from ... experience for all safety assessors