We personally care 31 May 2016 – Working Group on Cosmetic Products EU Cosmetics Regulation – Article 15.2 Criteria for exempting CMR1A and 1B from being banned in use in cosmetics “Availability of suitable alternative substances”

We personally care Background and Context In 2003 the Seventh Amendment to the EU Cosmetics Directive introduced hazard based ban of substances classified as CMR CMR 1A and 1B triggered a ban via Annex II listing without possibility of exemption CMR 2 substances triggered a ban via Annex II listing unless positive SCCS opinion In essence, the Seventh Amendment introduced a significant deviation from the principle of risk based regulation without considering exposure and actual use made regulation of cosmetics dependent on a hazard-classification maintained administrative control over the process in the Cosmetics Directive

We personally care Background and Context Vast majority of CMR 1 substances have no interest as cosmetic ingredients However, the hazard based approach can lead to absurd situations in exceptional cases, i.e. being forced to ban widely used, safe cosmetic ingredients (e.g. ethanol) Recast introduced exemption process to be used in such cases to avoid an unjustified and disproportionate impact Article 15.2 allows, subject to rigid conditions, for the use of these substances if they have been found to be safe by the Scientific Committee for Consumer Products (SCCS)

We personally care Background and Context 2008 Impact assessment on Cosmetics Directive Recast: Maintain principled policy of banning CMR 1A and 1B substances Exceptional derogation possible, subject to criteria main criterion “found safe by the SCCS “ (to be reconfirmed every 5 years), even when considering non-cosmetic exposure given the high number CMR classified chemicals (> 1400), systematic SCCS review is not possible and necessary (industry is only interested in few substances) Two additional conditions were introduced as “gatekeeper”. If fulfilled, path towards a safety evaluation by the SCCS is opened. compliance with EU food legislation, no suitable alternatives for the substance available.

We personally care Legal Text “substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled: - they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; - there are no suitable alternative substances available, as documented in an analysis of alternatives; - the application is made for a particular use of the product category with a known exposure; and - they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.”

We personally care Practical application No specific interpretation or implementation guidance, except for 2015 Guidance on overall exposure estimates Recent examples o(e.g. formaldehyde in nail hardeners) show urgent need for harmonised interpretation on Process Content Industry welcomes the possibility to work as a first on the criterion of ‘suitable alternatives’

We personally care Suitable Alternative substances – Procedural Aspects Assessment of suitable alternatives is a ‘gatekeeper’ to decide whether to go to SCCS Important for applicant to know as early as possible whether this condition is met, prior to spending significant financial and human resources on a full dossier Process must be transparent, based on clear criteria and thus have a predictable outcome Industry applicant submits an analysis of suitable alternative substances EC should share without delay with the Member States Within a specified timeframe Member States submit comments that are shared with the applicant Applicant responds to comments EU Commission decides whether condition is met and informs the applicant without delay. If the decision is positive, Commission asks SCCS for a safety review of the CMR substance

We personally care Suitable Alternative substances – Aspects of Scope No definition/guidance on the scope of “availability of suitable alternative substance” in the Cosmetics Regulation. Definitions and concepts are developed in other EU regulation, mainly REACH Article 60, and subsequent guidance documents Useful starting point for the implementation of the Cosmetics Regulation. However, note that REACH authorisation process and Article 15.2 exemption under the Cosmetics Regulation are not the same.

We personally care “What is an alternative ?” REACH Guidance : “An alternative is a possible replacement for the Annex XIV substance. It should be able to replace the function that the Annex XIV substance performs. The alternative could be another substance or it could be a technique (e.g. a process, procedure, device, or modification in end product) or a combination of technical and substance alternatives….” Contrary to REACH, the Cosmetics Regulation only mentions suitable alternative substances, not techniques. “suitable alternative substances”, under the Cosmetics Regulation, includes only substances, i.e. chemical elements and their compounds in the natural state or obtained by any manufacturing process.

We personally care “What is suitable ?” Dictionary definition “conforming or agreeing in nature, condition, or action; accordant; corresponding; analogous.” or “having the qualities that are right, needed, or appropriate for something”. Technical suitability Consideration of the function of the substance : -The task that the substance performs including the essential role it plays in the function and performance of the product -The conditions under which the substance is used in the finished product (e.g. formulation compatibility, galenic form) Identification of the function can only be performed with respect to a particular use

We personally care “What is suitable ?” Safety suitability Article 15.2 (re)introduces a risk-based approach Absence of CMR classification is not an indication of it being safer than the CMR substance Not a suitable alternative if its use would lead to an overall increased risk to human health Regulatory feasibility and sustainability Full compliance with applicable EU legislation (e.g. positive listing) Substance must not be banned / pending a ban (e.g. CLP Classification as CMR, environmental legislation, etc). NB: Animal test ban impacts on eventual data gaps

We personally care “What is available?” Commercially available for purchase and use by all interested companies. Sufficient quantities, including for future sustainable supply (e.g. natural resources, CITES, conflict minerals, etc) Economic viability of the use of the alternative based on investment costs (e.g. R&D, reformulation, change of equipment and manufacturing processes,…) recurring costs (price), revenues, pass-through cost to customers) potential market distortions

We personally care Conclusion An alternative substance is suitable if: It provides an equivalent function to that provided by the substance under consideration, resulting in a finished product with similar effect with a same level of efficacy; It will not lead to an overall increased risk to human health and the environment; It complies with requirements of other applicable EU legislation and does not require additional animal testing to substantiate its safety; It is freely available on the market in sufficient quantities in a sustainable manner; It is economically feasible for the whole industry to replace the CMR substance with the alternative substance.

We personally care Thank you for your attention