Within the European Union (EU) cosmetic products are regulated not only according to the corresponding cosmetic regulation but also to general chemical legislations. Therefore, it is of high importance to consider all the regulations applying to your products before exporting from Asia to countries within the EU.
Cosmetic legislations: Regulation (EC) No 1223/2009 (cosmetic products) and Regulation (EU) 655/2013 (cosmetic product claims)
The Cosmetic Directive 76/768/EC, which dated back to 1976, was replaced in 2009 by Regulation (EC) No 1223/2009 on finished cosmetic products. According to this new regulation, a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
With the Cosmetic Product Regulation in place, the safety of the consumers shall be ensured due to stricter safety requirements and the introduction of the so-called “Responsible Person”. The Responsible Person is accountable for the safety of the cosmetic product and has the obligation to implement a system to record serious undesirable effects and report such to the competent authority of the member state in which the serious undesirable effect was experienced. If applicable, the national authorities will forward the information on undesirable effects to the other EU-member states. In addition to the general safety requirements, stricter rules for nanomaterials used in cosmetic productshave been implemented. Cosmetic productscontaining nanomaterials have to be notifiedto the European Commission six month before placing the cosmetic product on the market. In case concerns are raised by the Commission, the nanomaterial may be subjected to a full safety assessment by the Scientific Committee of Consumer Safety (SCCS).
Regulation (EC) No 1223/2009 also addresses the content and structure of the Product Information File (PIF), which has to be prepared by the Responsible Person and must be made available to the authorities on request. A major part of the PIF is represented by the Cosmetic Product Safety Report (CPSR). The CPSR shall contain detailed information on the ingredients used, their toxicological profiles and the predicted safety of the product as concluded by the safety assessor. Information on microbiological contamination and the stability of the cosmeticproduct also have to be reported in the CPSR. It is important to note, that the CPSR does not contain any information about a potential environmental impact of the ingredients or the cosmetic product.
The Responsible Person also has to provide a list of animal studies performed by the manufacturer, his agents or suppliers on the cosmetic product or the ingredients used in order to comply with legislations of third countries.
Other chapters of the PIF deal with information on the product itself, the manufacturing process and the compliance with good manufacturing practice (GMP). The product label has to be provided, which features information such as the contact details of the Responsible Person, a list of the ingredients (INCI names), expiration dates and the cosmetic product claim. Claim substantiation is another imported part of the PIF. According to the Cosmetic Product Regulation, the Responsible Person shall provide proof of the cosmetic effect claimed. The detailed requirements for justified cosmetic product claims are addressed in Regulation (EU) 655/2013, which was implemented in 2013 in order to prevent false or misleading claims and help consumers to make informed purchase decisions. Some crucial points of the Cosmetic Claims Regulation are that claims have to be legally compliant, truthful, honest and fair. Furthermore, effects claimed shall be supported by well-designed and relevant studies.
Together with Regulation (EC) No 1223/2009, a central EU-wide notification system – the Cosmetic Products Notification Portal (CPNP) – has been introduced. All cosmetic products intended to be sold in an EU member state must be notified via the CPNP before they are placed on the EU market for the first time.
Chemical legislation: Regulation (EC) No 1907/2006 (REACh)
What non-EU cosmetic manufacturers may not be aware of is that cosmetic products and cosmetic ingredients exported to the EU fall within the scope of Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh). The REACh Regulation was implemented in 2006 in order to protect human health and the environment from the potential risks posed by chemicals. Thus, Regulation (EC) No 1907/2006 does not only apply to chemicals on their own but also to chemicals in many different types of finished products, including cosmetics. As mentioned before, the Cosmetic Product Safety Report (CPSR) does not consider environmental risks. This gap is closed by the Chemical Safety Report (CSR) under REACh which is required for substances exceeding 10 tonnes/year.
According to the REACh Regulation, companies located in the EU are obliged to register chemical substances, which they manufacture or import in amounts of 1 tonne/year or more. The registration deadlines for substances manufactured or imported in amounts of 100 tonnes/year or more have already passed. Substances reaching this tonnage band have to be registered immediately, in case that there is no pre-registration in place even before the manufacture or import into the EU can start. Substances manufactured or imported in amounts of 1-100 tonnes/year must be registered by the final REACh deadline on 31 May 2018. Up until 31 May 2017, companies benefitted from the grace period during which they can perform a simple late pre-registration in order to market their substances until 31 May 2018.
Late pre-registrations and registrations must be filed with the European Chemicals Agency (ECHA) through an online portal called REACH-IT. A successful registration under REACh requires detailed information on the substance in question. Regulation (EC) No 1907/2006 lays down the data requirements, which include more general information such as information on the registrant, identification of the substance, information on the manufacture and the uses, classification and labelling of the substance and guidance on safe use. A major part of the data requirements refer to relevant endpoints in order to determine the physio-chemical properties of the substance, the toxicity and other health effects as well as the ecotoxicity and environmental fate. The information requirements increase with the amount manufactured or imported.
The REACh-relevant tonnage is calculated as the total amount of the substance on its own and the substance contained in all finished products. Therefore, the REACh Regulation concerns not only chemicals intended to be used as cosmetic ingredients but also the ingredients contained in finished cosmetic products.
As the total tonnage increases with each product imported, many EU-based companies prefer to purchase cosmetic ingredients and cosmetic products from suppliers holding valid (pre-)registrations. Consequently, many non-EU manufacturers and formulators who export cosmetic ingredients and cosmetic products to the EU decide to adopt the obligation to register the substances according to the REACh Regulation in order to increase their business and ensure the loyalty of their EU-customers. Non-EU companies must appoint an Only Representative (OR) located in the EU, who will act as legal entity, perform late pre-registrations and submit registration dossiers on their behalf.
The first step before exporting to the EU: Compliance check!
As a first step before exporting, a thorough compliance check of your products is of high importance. Such a compliance check should include the verification whether the product in question is indeed considered a cosmetic product in the EU. As the definition of cosmetic products varies in different countries around the world, it is possible that the product in questions is considered a cosmetic product in the country of manufacture, but falls under the scope of other legislation within the EU. The intended use of the product and the effect claimed serve as a good basis in order to identify the product type. For example, in case the product comprises anti-bacterial properties or is intended to prevent or cure diseases, it is highly like that the product will be considered a biocidal product, a medical device or a medicinal product in the EU. Should the product fall under the scope of legislations other than the Cosmetic Product Regulation, higher data requirements and more challenging registration processes are to be expected.
Another important step during the process of compliance check is the verification of the product composition. It has to be ensured that all ingredients and the final concentrations used in the product are in line with the Cosmetic Product Regulation. This also refers to impurities. Regulation (EC) No 1223/2009 comprises a list of substances prohibited in cosmetic products (Annex II), a list of substances which may be used only under certain restrictions (Annex III) as well as lists of colorants (Annex IV), preservatives (Annex V) and UV-filters (Annex VI) allowed to be used in cosmetic products. It is important to consult those lists as substances allowed to be used in cosmetic products in the country of manufacture may be prohibited or restricted within the EU. The Annexes are amended on a regular basis.
For compliance with REACh, it is crucial to check whether the importer in the EU holds a valid pre-registration for the relevant ingredients (as such or in the cosmetic product). Alternatively, the non-EU supplier can appoint an Only Representative (OR) to take care of the relevant REACh duties.
Challenge for Asian cosmetic manufacturers: the animal testing ban
Even though the cosmetic product which shall be exported to the EU has been tested for safety and was already placed on the market in the in the country of manufacture, there is a risk that the existing data may not be used in order to meet the requirements of the Cosmetic Product Regulation.
According to Article 18 in Regulation (EC) No 1223/2009, cosmetic products, which have been subjected to animal testing or contain ingredients, which have been tested on animals in order to comply with the Cosmetic Product Regulation may not be placed on the EU market. Article 18 has been vividly discussed in the past as it leaves room for interpretation. The legal text can be understood literally or interpreted in the wider context ensuring animal protection. Therefore, many parties wonder if it is permitted to perform animal testing in order to meet requirements of regulations other than Regulation (EC) No 1223/2009 or to comply with cosmetic legislations of third countries.
In September 2016, the court (first chamber) of England ruled that it may be prohibited to sell cosmetic products in the European Union, which contain ingredients that have been tested on animals outside the EU in order to meet the requirements of cosmetic legislations in third countries. This sales ban is applicable if the generated data is used to demonstrate the safety of those cosmetic products in order to market them within EU.
For companies who manufacture cosmetic products in Asian countries which require animal testing in order to demonstrate the safety of the cosmetic products, this means that the existing animal studies must not be used in order to meet the requirements of Regulation (EC) No 1223/2009. Instead new safety data have to be generated through the performance of validated alternative methods (e.g. in vitroassays). Regulation (EC) No 440/2008, which lays down test methods consistent with the REACh Regulation, lists some alternative methods for endpoints that are relevant for the safety assessment of cosmetic ingredients. Furthermore, it is recommended to use alternative methods validated by the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM).
The REACh Regulation aims to keep the number of animal tests to an essential minimum. However, for some endpoints no validated alternative methods are available and animal testing cannot be avoided. Due to the animal testing ban laid down in the Regulation (EC) No 1223/2009, ECHA published a position paper on the interface between the REACh Regulation and the Cosmetic Product Regulation. Animal testing may not be performed for human health endpoints and adaptation possibilities may apply in case the substance in question is used only for the manufacture of cosmeticproducts and testing is not required in order to fulfil the REACh requirements for the assessment of worker exposure. Potential worker exposure may occur during the processes of manufacture, formulation or packaging. Registrants who use the substance in question not only for the manufacture of cosmetic products but also other purposes are permitted to perform animal testing as a last resort. For environmental endpoints all registrants are permitted to perform animal testing as a last resort. This means for non-EU manufacturerswho export only cosmetic products to the EU that they may not perform animal testing to meet the informationrequirements of human health endpoints.