The Virtual 5^th ERPA Annual Congress on

Regulations and Compliance for Cosmetics

Endocrine disruptors (EDs) are xenobiotics able to alter endocrine system homeostasis causing adverse health effects in an intact organism, or its progeny, or (sub)populations. Humans are frequently exposed to one or to a mixture of ED by inhalation, ingestion, and/or dermal contact of several products. Some suspected ED in cosmetics are under the EU lens, because they could increase the source of endocrine disruption in humans. EDs can be included in a cosmetic product as active principles, as a contaminant or as a by-product leached form packaging.

The ED mode of action does not fit to classical linear toxicology trend but shows non-linear trend and it can occurs at several levels of hormone homeostasis: firstly, influencing hormone’s binding to its specific receptor, but also by modifying hormone regulation, synthesis, secretion, transport and degradation. The uniqueness of EDs among all categories of xenobiotic substances imply a brand new strategy for assessing their effect on products used daily by humans. A case by case strategy for assessing safety of ED in cosmetics suggested by Prof. Vera Rogiers (SCCS Co-chair) is in line with ED action. In this scenario, some tests should be mandatory and included in the safety evaluation of all ED compounds in cosmetics.

The possible presence of ED in cosmetics opens a new branch of studies on human exposure, usually not included in classical toxicology, but more related to endocrinology. Therefore, a new role for experts in this field should be considered when evaluating safety of ED in cosmetics.

– Status of the impact assessment on fragrance allergens labelling

– Implications

– Implementation

During these challenging times, the resilience and adaptability of the European Cosmetics sector is a perfect example of an industrial sector resisting, while contributing to society’s wellbeing and even health protection against COVID-19. In spite of the pandemic, a number of activities have been initiated, are progressing or have been concluded in the cosmetics sector. In this presentation, the Commission services have outlined in a short, yet comprehensive way, all activities within the cosmetics sector related to three main topics: (i) Substances with endocrine disrupting properties, (ii) nanomaterials and (iii) the “Chemicals Strategy for Sustainability” as part of the Commission’s Green Deal. For each of these topics, an overview of the Commission activities is presented, together with follow-up proposals and future actions.

– Overview of the compliance process – what does it imply?

– Why it is crucial to be first compliant?

– RAPEX

– SUE / UE

– keeping your PIF, including SA report, updated periodically

To be compliant on the process before sales need a couple of measures that to be anticipated. First, to be compliant it means to contribute to consumer safety and to the protection of their health. The good understanding of the respective roles and responsibilities of each person involved on the sales chain ensures compliance with the Cosmetics Regulation. The setting of an information system: PIF (product information file) and safety assessment report are the required steps, not only before to place on the market but also during all the time market. This follow-up establishes an organized system for the exchange of information concerning products that may affect the health and the safety of consumers by means RAPEX : Rapid Alert System for dangerous non-food products is the EU rapid alert system notifying member states about risks to the health and safety of consumers.

– Overview of 22716 requirements

– Highlights on how important is to be GMP certified

The Cosmetics Regulation (EC) 1223/2009 requires that all cosmetic products placed on the European market comply with Good Manufacturing Practices (GMP) set by the ISO 22716 standard. This standard covers the quality aspects of the product. It gives guidelines for the production, control, storage and shipment of cosmetic products. GMP concern all those involved in the manufacture, such as: raw materials providers, finished product manufacturers, distributors, importers / exporters. It’s important to note that ISO 22716 does not cover aspects of protection of the environment. This presentation presents the goal of GMP for cosmetic products (e.g. : prevent contamination, prevent mix ups and errors, establish process controls,…) and how set up a couple of measures that have to be implemented in relation to the manufacturing process, control, storage and shipment. Also, the following questions: how GMP affect product processing and how make audit of the quality systems ? are discussed.

– type of cosmetic cases reaching the court

– What happens then and there?

– how is the court interpreting the cosmetics regulation 1223/2009/EC

As any industrial product, cosmetic products are sometimes subject to legal expertise, always with the objectives to assure the protection of the consumer and to protect their health. Expertise cases are subject of various investigations lead by judicial experts and under the direction of an investigating judge. Identification of counterfeits, search for unauthorized substances, investigation of non – compliant labeling, misleading product, are all cases that can be submitted to expertise…

– What is the status?