Consumers have responded to e-commerce...

Consumers have responded to e-commerce, globalized brands, celebrities’ beauty lines and influencer marketing by expecting that all cosmetic products are immediately available anywhere in the world.

Meantime a deep technical compliance is needed, also considering some important differences among the principal worldwide legislation especially considering sunscreen, anti-wrinkle and antiperspirant products.

As technical and regulatory consultants, we support our clients to bring their products to the European and international markets.

Our services include:

  • Formula compliance
  • Raw materials compliance
  • Ensuring manufacturing following the GMP
  • Label assessment
  • Label text preparation
  • Regulatory translation
  • Preparation and maintenance of the Product Information File (PIF)
  • Preparation and maintenance of the Cosmetic Product Safety Report (including the Safety Assessment)
  • Notification through the European Cosmetic Product Notification Portal (CPNP)
  • Advertising assessment
  • Management of Undesirable Effects (UE) and of Serious Undesirable Effects (SUE) – Cosmetovigilance
  • Management of recalls and the EU rapid alert system for dangerous non-food products (RAPEX)

According to Article 13, Regulation (EC) No 1223/2009, prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, a notification to the European Commission.

No, the notification to the European Commission through the CPNP is sufficient and fulfills the obligation in the whole EU.

According to Article 11, Regulation (EC) No 1223/2009, when a cosmetic product is placed on the market, the responsible person shall keep a product information file for it which should contain the following information:
(a) a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
(b) the cosmetic product safety report
(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice
(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries

According to Article 10, Regulation (EC) No 1223/2009, 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.

According to Annex I, Regulation (EC) No 1223/2009, the cosmetic product safety report shall, as a minimum, contain the following:

PART A – Cosmetic product safety information

  1. Quantitative and qualitative composition of the cosmetic product
  2. Physical/chěmical characteristics and stability of the cosmetic product
  3. Microbiological quality
  4. Impurities, traces, information about the packaging material
  5. Normal and reasonably foreseeable use
  6. Exposure to the cosmetic product
  7. Exposure to the substances
  8. Toxicological profile of the substances
  9. Undesirable effects and serious undesirable effects
  10. Information on the cosmetic product

PART B – Cosmetic product safety assessment

  1. Assessment conclusion
  2. Labelled warnings and instructions of use
  3. Reasoning
  4. Assessor’s credentials and approval of part B

According to Article 8, Regulation (EC) No 1223/2009, the manufacture of cosmetic products shall comply with Good Manufacturing Practice (GMP). Compliance with GMP shall be presumed where the manufacture is in accordance with the relevant harmonised standards.

According to Articles 14, 15, 16 and 17, Regulation (EC) No 1223/2009, there are some restrictions applied to substances or categories of substances. As a preliminary assessment, annexes from II to VI of the Regulation should be carefully checked.

According to Article 19, Regulation (EC) No 1223/2009, the ingredients list shall be expressed by using the common ingredient name (INCI) set out in the European glossary and does not need to be translated in the national languages. The other mandatory information should be translated into the national language provided by the Member States.

The notification through the CPNP is valid for marketing in the whole EU. An update to the notification could be needed in some cases.

According to Article 4 , Regulation (EC) No 1223/2009, only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.

According to Article 19, Regulation (EC) No 1223/2009, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear, among other mandatory information, the name or registered name and the address of the responsible person.

According to Article 19, Regulation (EC) No 1223/2009, a date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the open jar symbol followed by the period (in months and/or years).

According to Article 19, Regulation (EC) No 1223/2009, particular precautions and the ingredients list can be reported on a leaflet inside the box where the open book symbol can appear.

According to Article 18, Regulation (EC) No 1223/2009, animal tests are prohibited for cosmetic products and their ingredients, so this claim would follow among claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements and thus should not be allowed as it is.

In the EU all cosmetic products should be compliant with the Regulation (EC) No 1223/2009, products sold online too. Among other obligations, a notification through the CPNP and the translation of labels into the national language/s are mandatory.

According to the annex of the Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products, claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments.

According to p. 5 Article 219 of legislative decree No 152/2006 all packaging should be appropriately labeled […] to facilitate the collection, reuse, recovery and recycling of packaging, as well as to ensure correct information to consumers on the final destination of packaging. No exemption has been foreseen for cosmetic products.

According to the Communication 52445 of the Italian Ministero della Transizione Ecologica in case of small packaging (capacity <125 ml or larger surface <25 cm2) or with limited printed spaces and in case of packaging with multilingual labels, where the target market is not known upstream the use of digital support tools (such as App, QR code, barcode or, where these paths are not practicable, the provision of such information on websites) to support communication of the environmental information can be foreseen.

According the LOI n° 2020-105 du 10 février 2020 “relative à la lutte contre le gaspillage et à l’économie circulaire”, also known as the Loi AGEC, the Triman logo will be required in France starting from 2022 also on cosmetic products.

According to the “Décret n° 2021-835 du 29 juin 2021 relatif à l’information des consommateurs sur la règle de tri des déchets issus des produits soumis au principe de responsabilité élargie du producteur” information on sorting will be mandatory together with the Triman logo.

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