Examples of experiences in EU countries -experience of Slovenia regarding achieving national capacity for safety assessment of
cosmetic products
dr. Anja Menard Srpčič
TAIEX Workshop on Safety Assessment of Cosmetics
15. 11. 2019, Beograd, Serbia
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Chemicals Office of the Republic of Slovenia (CORS)
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Ministry of Health
Chemicals Office of theRepublic of Slovenia
Health Inspectorateof the Republic of Slovenia
Slovenian radiationprotectionadministration
Performs professional and administrative tasks based on the cosmetic legislation
CA for Chemicals Act, cosmetic products, biocidal products, POP‘s, PIC, REACH, CLP, detergents, precursors for illicite drugs, strategic material of special significance for security and health, electric and electronic devices, biomonitoring, etc.
Performs inspection over implementation of laws and other regulations with the objective of ensuring public health covering: cosmetic products, infectious diseases,drinking waters, general product safety, toys, food contact materials, alcohol, tobacco, etc.
Performs tasks relatedto professional issues, authorisation andenforcement in the fields of radiation protection and safe use of radiation sources.
(Bodies within Ministry of Health)
• Located in Ljubljana • Founded in August 1999 based on the Chemicals Act*• Mission: to provide chemical safety in Slovenia.
*Official Gazette RS , No. 110/03, 47/04 – ZdZPZ, 61/06 – ZBioP, 16/08, 9/11 and 83/12 – ZFfS-1)
Regulatory Framework
• Regulation (EC) No 1223/2009 on cosmetic products determine
– Article 3: Safety
– Cosmetic products made available on the market must be safe for human health under normal or reasonably foreseeable conditions of use.
– Article 10: Safety assessment
– Responsible person has to ensure, prior to placing a cosmetic producton the market, that the Cosmetic Product Safety Assessment has beenperformed and this safety has been demonstrated through a Cosmeticproduct safety report (Annex I).
– Cosmetic product safety assessment has to be carried out by a personwith appropriate qualifications and expertise.
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Adapting to requirements of the Regulation • Qualifications for safety assessors (clearly defined)
- Article 10 (2) Regulation (EC) No. 1223/2009 and Guidelines:
- Safety assessment has to be carried out 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 MS.
- Challenges : A lot of Q about the meaning of “similar discipline”- Which is an appropriate study program?
- Case-by-case basis
- Formal qualifications (check if the study program include basic scientific knowledge needed for safety assessment) and additional trainings and experiences
- Court Case C–13/17 (ecotoxicology)
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Regulatory Framework• Regulation (EC) No 1223/2009 on cosmetic products
– Article 11: Product information file (PIF)
– When a cosmetic product is placed on the market, responsible person has to keep a PIF (kept for a period of ten years).
– PIF has to contain the Cosmetic product safety report (including cosmetic product safety assessment)
– Responsible person has to make PIF readily accessible in electronic or other format at his address indicated on the label to the CA of the MS in which the file is kept. The information contained in the PIF shall be available in a language which can be easily understood by the CA of the MS.
• Information should be in Slovene language (technical and scientific information → English)
• Some MS have in their national law the provision that the PIF should be in their national language
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Regulatory Framework
• Regulation (EC) No 1223/2009 on cosmetic products
– Annex 1: Cosmetic Product Safety Report (CPSR)
– Content of the CPSR is described
– Consisting of Part A → Cosmetic product safety information
Part B → Cosmetic product safety assessment
• Commission implementing decision on Guidelines on Annex I to Regulation (EC) No 1223/2009 on cosmetic products
– Provide the guideline for the preparation and structure of CPSR (safety assessment) which is of assistance in particular to SME.
– Guideline are not meant to replace the knowledge and expertise of the qualified safety assessor
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National legislation
• Decree on implementing Regulation (EC) on cosmetic products (Official Gazette RS, No. 61/13)
– Provisions on penalties for non-compliance with provisions in Regulation on cosmetic products
– National provisions regarding notification of responsible person activities, language, microbiological suitability, competent authority, etc.
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Guidances and other documents
• SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision (SCCS/1602/18)– Contains relevant information on the different aspects of testing and
safety evaluation of cosmetic substances in Europe– Aim is to provide guidance to public authorities and cosmetic industry in
order to improve harmonised compliance with the current cosmetic EU legislation
• SCCS Guidance on the safety assessment of nanomaterials in cosmetics(SCCS/1611/19)– Provide an overview of the key issues and data requirements relating to
the safety assessment of NMs in cosmetics• Safety assessment of the ingredients by SCCS• Court cases • Free information sources on the internet (e.g. published literature, other
relevant documents, …)
SCCS - Scientific Committee on Consumer Safety
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Training in the field of safety assessment
• Attended different trainings:
• Trainings within Twinning project „Chemical Safety 3„, 2009
• Regulation (EC) No 1223/2009 on cosmetics (1 day training) – Training for competent authority, inspectors and industry
– Experts from German Environment Agency (Umweltbundesamt – UBA) presented: overview of the new EU Cosmetic regulation (changes) and safety assessment of cosmetics in Europe (general principles of the safety assessment of cosmetics (hazard, exposure, risk and Mos calculation))
• Basics of toxicology with introduction to risk assessment (STox 2008) (3 weeks)– Training for competent authority, laboratories, industry, research institutions, ...
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Training in the field of safety assessment
• University of Ljubljana, Faculty of Pharmacy
• organized scientific workshop: Trends in the field of the cosmetic products, Efficiency and safety of ingredients (legislation, structure and function of the skin, natural ingredients, safety and efficiency of perservatives, progress of scientific knowledge, …)
• Annual education/training program
• planned in advance;
• attending training course, workshops, specialized toxicology course,…
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Dealing with expert questions
• Decree on implementing Regulation (EC) on cosmetic products
• Article 2: Dealing with expert questions
Following a proposal of the competent authority for chemicals, the Minister shallappoint a Cosmetics Commission composed of experts in medicine, pharmacy,cosmetics, toxicology, chemistry and other fields for dealing with expertquestions in connection with this act and for the preparation of expert opinions.The work of the Cosmetics Commission shall be harmonised by the competentauthority for chemicals.
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National institute of Public Health (NIJZ)
• NIJZ is public health institution in Slovenia funded by the government,whose main aim is to study, protect and improve the level of health ofSlovenian population with the help of preventive measures.
• NIJZ performs risk assessment for human health
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https://www.nijz.si/en
Collaboration with...
• Inspectors (Health inspectorate)
• Colleagues from National institute of Public Health (NIJZ)
• Faculty of Pharmacy
• Colleagues from other Member States
• Chamber of Commerce and Industry of Slovenia (CCIS), – Association of Cosmetic, Detergent and Cleaning products Producers
of Slovenia
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Ways to support companies
• Organising seminars and workshops for industry in collaboration with other organisation– Focusing on: legislation and novelty, Cosmetic product safety
report, including safety assessment
• Face-to-face meetings with companies• Publishing guidance documents on our dedicated webpage;
Update of the website to make the information more accessible/understandable
• A single entry point for e-questions ([email protected]), telephone service with the name of the person on webpage
• Published articles• Challenges for SME: lack of knowledge, costs, etc. • Listing of consultants on webpage → not possible
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Thank you very much!
Chemicals Office of the Republic of Slovenia https://www.gov.si/drzavni-organi/organi-v-sestavi/urad-za-kemikalije/
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