The Polish Union of the Cosmetics Industry reaction to the Draft Ordinance on the organisation of the certification process of good manufacturing practices for cosmetic products and the authorisation of control officers
(TRIS 2023/0537/FR)
The Polish Union of the Cosmetics Industry calls on the European Commission to examine the Draft Ordinance[1] amending French Public Health Code by adding the new article L. 5131-7 towards the compliance with the EU Cosmetic Products Regulation. We also calls the European Commission to extend the standstill period as necessary.
The new Draft regulation – national GMP requirements
The Union identifies that the Draft Ordinance inserts a new article L. 5131-7 in the French Public Health Code. This new article together with Article 205 of the French Finance Act No 2022-1726[2], impose on certain establishments manufacturing and packaging cosmetic products on the French territory, to have their manufacturing and packaging practices certified by an accredited certification body for compliance with good manufacturing practices (‘GMP’) referred to in Article 8 of the Cosmetic Products Regulation[3]. The modalities for implementation of the certification system will be specified by a decree of the French Council of State. This new compulsory pre-requisite certificate differs from the certificate that can be requested in France on a voluntary basis for exporting cosmetic products outside de EU[4].
GMP regulations and compliance under the Cosmetic Products Regulation 1223/2009/EC
The Cosmetic Products Regulation requires all cosmetics products placed on the market to be manufactured according to the Good Manufacturing Practices.
The Cosmetic Products Regulation does not impose a specific method of GMP to be followed. However, Article 8(2) of the Cosmetic Products Regulation introduces a presumption of compliance with the GMP when “the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union”.
The compliance with the principles of GMP is monitored via in-market control by the Member States competent authorities, based on of Article 22 of the Cosmetic Products Regulation.
The regulation 1223/2009/EC does not require any kind of a certificate to demonstrate the compliance with GMP. It is sufficient, as per article 11.2.(c) of the Cosmetic Products Regulation, that the product information file contains a description of the method of manufacturing and a statement on compliance with GMP.
Compliance of the French Draft Ordinance with the regulation 1223/2009/EC
Obligations of the companies in the supply chain, including the GMP requirements are regulated by the Cosmetic Products Regulation.[5]
According to the article 8 of the CPR (Good Manufacturing Practice) the manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1, namely safety of the products. Further, article 8 stipulates that compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
In the opinion of the Union Member States should not impose a particular standard to be followed as regards GMP for the manufacturing of cosmetic products as this could be seen to be in infringement of Article 8 of the Cosmetic Products Regulation, which leaves the choice of the GMP method to the manufacturer.
Article 11 (Product information file) stipulates that the product information file shall contain a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8.
Therefore, any requirements introduced by a Member State to regulate the compliance by establishments with GMP should be compatible in particular with the principle of self-declaration of compliance with the GMP foreseen by Article 11.2(c) of the Cosmetic Products Regulation.
Article 9 (Free movement) stipulates that Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.
Therefore, the Union is of the opinion that the French authorities cannot prohibit placing on the market the products which will be incompliant with the new French Draft Ordinance.
The monitoring by Member States of the GMP for cosmetic products has to be done in compliance in particular with Article 22 of the Cosmetic Products Regulation in the frame of the in-market control, i.e after the products are placed on the market. It could therefore be questioned whether an a priori certification is in line with this Article 22 od the regulation 1223/2009/EC.
Conclusions
In the opinion of the Polish Union of the Cosmetics Industry the new French Draft Ordinance is not compliant with a regulation 1223/2009/EC. The Union calls the European Commission to investigate this Draft Ordinance according to the procedure TRIS 2023/0537/FR.
About the contributor:
The Polish Union of the Cosmetics Industry, as the only organisation in Poland, represents and supports the strategic goals of entrepreneurs exclusively in the cosmetics industry. For over 21 years it has been an active voice of the sector in the process of law making. It effectively cooperates with institutions of Polish and European administration on a daily basis, and together with member companies it develops and implements solutions that lead to the development of the Polish cosmetics market, which is now fifth in the European Union.
The Union is a member of the Cosmetics Europe - the European trade organisation and Confederation Lewiatan - the most influential organisation of employers in Poland. It is also involved in activities building the position of the sector abroad and helps promote the export of Polish cosmetics, builds a network of partnerships and, together with partners, removes barriers in international trade. The organisation also acts as a platform for the exchange of experiences - educates and trains companies, improving the quality of the entire sector. For 17 years, it has also been conducting the social project Beautiful Life Foundation.
The Union brings together almost 270 companies, including cosmetics producers and distributors, laboratories, consulting companies and teaching centres, as well as their branch partners - suppliers of packaging and raw materials. It unites and works for startups, small family businesses as well as large international corporations and the largest Polish cosmetics companies, which work together effectively in an atmosphere of mutual respect and trust, while maintaining all competition rules.
[3] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, O.J., L 342, 22 December 2009, p. 59.
[5] As per the Cosmetic Products Regulation, only safe cosmetic products for which a Responsible Person is designated in the EU can be placed on the market (Articles 3 and 4.1). For each cosmetic product placed on the market, the Responsible Person shall ensure compliance with the relevant obligations set out in the Cosmetic Products Regulation (Article 4.2), and in particular with Article 8 (compliance with GMP) and Article 11.2.(c) (self-declaration of compliance with GMP in the product information file). As per Article 25 of the Cosmetic Products Regulation, the national authorities could request the Responsible Person to take all appropriate actions in case of non-compliance in particular with the GMP referred to in Article 8 of the Cosmetic Products Regulation.
