SEMINAR /WORKSHOP ON INTRODUCTION OF EU LEGISLATION

ON COSMETIC PRODUCTS

TAIEX Serbia 22-23.02.2016

MSc Ivona Vidić Štrac, Biol.Sci-Toxicology

Head of Department of Objects of Common Use
Croatian Institute of Public Health
Voditeljica Odjela za predmete opće uporabe
Voditeljica Odsjeka za predmete široke potrošnje i praćenje sigurnosti kozmetičkih
proizvoda, Hrvatski zavod za javno zdravstvo
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 30 November 2009 on cosmetic products

 Preambula 20

To ensure the uniform application and control of the

restrictions for substances, sampling and analysis should be
carried out in a reproducible and standardised manner.
 CHAPTER VII
MARKET SURVEILLANCE
Article 22
In-market control
 Member States shall monitor compliance with this Regulation via
in-market controls of the cosmetic products made available on
the market.

 They shall perform appropriate checks of cosmetic products and

checks on the economic operators on an adequate scale, through
the product information file and, where appropriate, physical
and laboratory checks on the basis of adequate samples.
PEMSAC
 EU countries are responsible for the surveillance of their own
markets for cosmetics. In order to ensure a coherent approach
to consumer products issues, the market surveillance
authorities of all EU countries established the Platform of
European Market Surveillance Authorities for Cosmetics

 PEMSAC Sub-group ANALYTICAL METHODS

 Analytical methods

http://ec.europa.eu/growth/sectors/cosmetics/assessment/index_en.htm
EU Book shop
Council of Europe - European Directorate for Quality of Medicines
and Healthcare - EDQM

https://www.edqm.eu/en/cosmetics-testing
EDQM - OCCL
Official Cosmetics Control Laboratories (OCCLs) check the quality of cosmetic
products on the market and support market surveillance activities of the
competent authorities. By alerting authorities to products that do not comply
with national and European regulations for cosmetic products, OCCLs contribute
to consumer health protection.
 EDQM - OCCL

 The European Network of national OCCLs was set up on a

voluntary basis; more than 30 OCCLs participate in
regular network activities, including laboratories in 19
Member States of the European Union.
 An OCCL is a public institution with a mandate to perform
laboratory testing of cosmetic and other products as
appropriate, for the purpose of market surveillance.
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC960
82/15.06.18_eur27284_jrc-report-cosmetics%20final.pdf

Cooperation PEMSAC+EDQM-OCCL + CEN TC 392Cosmetics

Common approach

 In order to ensure that testing results related to official

controls are sufficiently robust and reliable, the analysis
should be performed in accordance with the principles laid
down in ISO 17025:2005 – General requirements for the
competence of testing and calibration laboratories
Selection of the method based on its validation status

 1-Community method
 2-CEN European standard (EN) or ISO/CEN standard (EN ISO)
 3-Other internationally harmonised protocols (e.g. OCCL
harmonised and validated methods11; CEN Technical
Specifications (CEN/TS));
 4-Ring-trial validated method;
 5-Single-laboratory validated method;

this method should be applied to perform the analysis.

 CEN /ISO Cosmetics- Analytical methods,
at 11-February 2016

 Nitrosamines: Detection and determination of N-

nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post-column
photolysis and derivatisation (ISO 10130:2009)
 Nitrosamines: Detection and determination of N-
nitrosodiethanolamine (NDELA) in cosmetics by HPLC-MS-MS (ISO
15819:2014)
 Quantitative determination of zinc pyrithione, piroctone olamine and
climbazole in surfactant containing cosmetic anti-dandruff products
(EN 16342:2013)
 Determination of 3-iodo-2-propynyl butylcarbamate (IPBC) in cosmetic
preparations, LC-MS methods (EN 16343:2013)
 Screening for UV-filters in cosmetic products and quantitative
determination of 10 UV-filters by HPLC (EN 16344:2013)
 GC/MS method for the identification and assay of 12 phthalates in
cosmetic samples ready for analytical injection (EN 16521:2014)
 CEN /ISO Sun protection test methods
at 11-February 2016

 In vivo determination of sunscreen UVA protection (ISO

24442:2011; EN ISO 24442:2011)
 Determination of sunscreen UVA photoprotection in vitro (ISO
24443:2012; EN ISO 24443:2012)
 Sun protection test methods - In vivo determination of the sun
protection factor (SPF) (ISO 24444:2010; EN ISO 24444:2010)
 Review and evaluation of methods to assess the
photoprotection of sun protection products (ISO/TR
26369:2009; CEN ISO/TR 26369:2009)

9 analytical methods and review

CEN/ISO Cosmetics – Microbiology, at 11-February 2016

 Evaluation of the antimicrobial protection of a cosmetic

product (ISO 11930:2012; EN ISO 11930:2012)
 Enumeration of yeast and mould (ISO 16212:2008; EN ISO
16212:2011)
 Microbiological limits (ISO 17516:2014; EN ISO 17516:2014)
 Detection of specified and non-specified microorganisms (ISO
18415:2007; EN ISO 18415:2011)
 Detection of Candida albicans (ISO 18416:2007; EN ISO
18416:2009)
 Guidelines for the risk assessment and identification of
microbiologically low-risk products (ISO 29621:2010; EN ISO
29621:2011)
CEN/ISO Cosmetics - Microbiology , 11-February 2016,
 General instructions for microbiological examination (ISO
21148:2005; EN ISO 21148:2009)
 Enumeration and detection of aerobic mesophilic bacteria (ISO
21149:2006; EN ISO 21149:2009)
 Detection of Escherichia coli (ISO 21150:2006; EN ISO
21150:2009)
 Detection of Pseudomonas aeruginosa (ISO 22717:2006; EN
ISO 22717:2009)
 Detection of Staphylococcus aureus (ISO 22718:2006; EN ISO
22718:2009)

8 microbiological methods with guidelines and instruction

 At the end, standards for manufacturers

 Cosmetics -- Packaging and labelling (ISO 22715:2006)

 Cosmetics -- Good Manufacturing Practices (GMP) --
Guidelines on Good Manufacturing Practices (ISO
22716:2007; EN ISO 22716:2007)
 Cosmetics -- Good Manufacturing Practices -- General
training document (ISO/TR 24475:2010; CEN ISO/TR
24475:2013)

3 general standards
Thank you for your attention!