understanding the cosmetic products regulation 1223/2009 ......2013/10/15 · dr. a. struessmann,...

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Understanding the Cosmetic Products Regulation 1223/2009 and REACH

Dr. Annelie Struessmann, Technical Director, CONUSBAT

London, 15. October 2013

Dr. A. Struessmann, 15. October 2013

Understanding the Cosmetic Products Regulation 1223/2009 and REACH 2

Agenda

● EU Sector Industry Legislation

● Key Elements of REACH and the CPR

● Interfaces for the Regulatory Frameworks

● Testing Requirements from REACH

● The Animal Testing Ban

● Conclusions - Q & A



The internal market is the core of today’s European

Union and as a consequence people, goods, services

and money move around as freely as they do within

one country.

The Single or Internal Market



1. Automotives 2. Chemicals 3. Construction products 4. Cosmetics 5. Return of cultural goods 6. Defense related products 7. Electrical equipment 8. Equipment intended for use in

Potentially Explosive Atmospheres (ATEX)

9. Footwear 10.Gas Appliances

11.Medical devices 12.Mechanical equipment

(machinery, lifts) 13.Metrology and pre-packaging 14.Pharmaceuticals 15.Pressure equipment 16.Radio and telecommunications

terminal equipment (R&TTE) 17.Rail 18.Textiles 19.Toys 20.Weapons and many others

The Single Market for Goods – Regulated Industry Sectors



*http://europa.eu/documentation/legislation/pdf/oa8107147_en.pdf

THE ABC OF EUROPEAN UNION LAW*



is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

REACH

REACH > > > > Registration, Evaluation,

Authorization and Restriction of Chemicals

> Pre-market approval





Cosmetic Products Regulation (CPR)

The Cosmetics Regulation requires that every cosmetic product placed on the market in Europe is safe to use. The manufacturer must ensure that cosmetic products undergo an expert scientific safety assessment before they are launched for sale.

> In-market Surveillance


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.


*[Regulation (EC) Nr. 1223/2009]



SUMMARY:

Regulation (EC) Nr. 1223/200 is the decisive framework for Cosmetic Products The Cosmetics Product Regulation contains legal provisions for the product ingredients (ingredient lists in the CPR‘s annexes), for product labelling and on animal testing. Also, the identification and labeling of hazardous substances is regulated in the CPR.

● REACH APPLIES TO COSMETIC INGREDIENTS, BUT NOT TO COSMETIC PRODUCTS

● COSMETIC PRODUCTS -MIXTURES IN THE FINISHED STATE, INTENDED FOR THE FINAL USER- ARE EXEMPT FROM ALL PROVISIONS OF CLP



> pre-market approval

Test Requirements for Registration > 1 t/a

Annex VII > 10 t/a

Annex VIII > 100 t/a Annex IX

> 1000 t/a Annex X

Price Euro

Acute oral X X X X 1.500

Acute dermal X / O X/O X/O 2.000

Acute inhalative X /O X/O X/O 11.700

Skin irritation X X X X 1.500

Eye irritation X X X X 1.500

Sensitization X X X X 4.200

Ames assay X X X X 3.200

Chromosome aberration O X X X 19.200

Additional mutagenicity studies O X X X 17.300

Reprotox Screening X 54.600

Teratogenicity X X 63.100

28 day test X O 49.400

90 day test X X 115.000

Chronic study O 300.000

2 generation study O O 328.000

Carcinogenicity study O 780.000

REACH

Source: Regulatory Workshop InCosmetics 2011 – M.Kleber

>

O: Involves an expert decision


Cosmetic Products Regulation (CPR)

Manufacturer Responsibility for

Product Safety

Cosmetic Product Safety

Assessment

> In-market Surveillance

*SCCS - Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation, 8th Revision http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf


1 Acute toxicity ................................................................................ 2 Corrosivity and irritation ............................................................... 3 Skin sensitization ........................................................................... 4 Dermal / percutaneous absorption .............................................. 5 Repeated dose toxicity .................................................................. 6 Reproductive toxicity ..................................................................... 7 Mutagenicity / genotoxicity............................................................ 8 Carcinogenicity .............................................................................. 9 Toxicokinetic studies ...................................................................... 10 Photo-induced toxicity ................................................................. 11 Human data ..................................................................................

RELEVANT TOXICITY STUDIES ON COSMETIC SUBSTANCES*


Comparison of Test Requirements

REACH CPR

Acute oral Acute toxicity

Acute dermal " Acute inhalative '

Skin irritation Corrosivity and irritation

Eye irritation "

Sensitization Skin sensitization

Ames assay Mutagenicity/genotoxicity

Chromosome aberration '

Additional mutagenicity studies '

Reprotox Screening Reproductive toxicity

Teratogenicity '

28 day test Repeated dose toxicity

90 day test '

Chronic study '

2 generation study ' Carcinogenicity study Carcinogenicity

Dermal / percutaneous absorption

Toxicokinetic studies

Photo-induced toxicity

Human data




Ban on Animal Testing




IMPLEMENTATION DEADLINES

• Testing ban on finished cosmetic products 11 Sept. 2004

• Testing ban on ingredients or combination of ingredients 11 March 2009

• Marketing ban when tested for human health effects with 11 March 2009 the exception of the specific effects of repeated-dose toxicity, reproductive toxicity and toxicokinetics

• Marketing ban when tested on the specific effects 11 March 2013

The ban applies irrespectively on the availability of alternative non-animal tests



REACH - Information Requirements, Test Methods and Quality of Data

Article 13(3) of the REACH Regulation requires that new tests need to be performed acc. to the test guidelines in Regulation (EC) No. 440/2008* or in accordance with other international test methods recognized by the European Commission or ECHA.

*http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:142:SOM:EN:HTML



Status on Validation of In-Vitro Alternatives to Animal Testing

Acute systemic toxicity Recommendations

Skin irritation / corrosion Validated in vitro test methods

Eye irritation Validated in vitro test methods

+ peer reviews

Sensitization Peer reviews

Mutagenicity/genotoxicity Validated in vitro test methods

Reproductive toxicity Peer reviews and foreseen validations &

accepted methods

Repeated dose toxicity -

Carcinogenicity study Recommendations and drafts

Dermal / percutaneous absorption Validated in vitro test methods

Toxicokinetic studies Peer review

Photo-induced toxicity Validated in vitro test methods EU COMMISSION COMMUNICATION on the animal testing and marketing ban – March 2013: http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/com_at_2013_en.pdf

Tracking System for Alternative test methods: http://tsar.jrc.ec.europa.eu/index.php?endpoint=6&method=6



Other Alternatives to Animal Testing - in-silico, in-chemico methods

ADVERSE OUTCOME PATHWAYS



CONCLUSIONS

The future of safety assessment for cosmetic ingredients and other chemicals is a multi-tier approach of using in-vitro, in-silico and in-chemico methods. Actually, many elements are available, however, some are still under exploration.

Multi-tier approaches will assure compliance with REACH and the CPR.

The animal testing ban does not apply to chemicals with application in other areas than cosmetics - therefore, no break in seeking REACH compliance exists. This includes chemicals used as cosmetic ingredients when multiple applications exist.

For many new cosmetic ingredients the existing alternatives already allow for a comprehensive safety assessment according to Annex I/CPR - read-across and tests on humans are examples for data sources in weight-of-evidence approaches which can be used in addition to alternative testing.

As REACH applies only from a threshold of 1 tonne/year, cosmetics assessed in a WoE approach can be introduced into the EU internal market.

Delays in innovation due to the animal testing ban will appear in only minor dimensions.




Costs? - Facts ● An increased demand for experts and science

sector specialists is required.

● The number of tests and costs per test will be reduced.

● An issue is the availability of experts.

● When comparing costs for a multi-tier alternative approach to a set of animal tests priorly used they appear to be in similar dimension.


Dr. Annelie Struessmann Kruppstr. 18 D-52072 Aachen, Germany

Tel: +49241 51857790

Skype: annelie.struessmann

[email protected]

www.conusbat.com

understanding the cosmetic products regulation 1223/2009 ......2013/10/15 · dr. a. struessmann,...

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