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EUROPEAN COMMISSIONENVIRONMENT DIRECTORATE-GENERALCircular Economy and Green GrowthSustainable Chemicals DIRECTORATE-GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES Consumer, Environmental and Health TechnologiesREACHChemicalsBrussels, 07/03/2017Doc. MSCA/08/2017 23rd Meeting of Competent Authorities for REACH and CLP (CARACAL)Open SessionRoom: 1A Centre Albert BorschetteRue Froissart 36 1040 Brussels, BelgiumConcerns: AT paper on Clarification on scope exemptions of Regulation (EC) No 1272/2008 for pure essential oils used as cosmetics – problem description and possible solutionAgenda Point:CLP point 24Action Requested:For information and discussion.Written comments on this document should be sent by 24 April 2017 to GROW-CARACAL@ec.europa.eu, HYPERLINK "mailto:ENV-CARACAL@ec.europa.eu" ENV-CARACAL@ec.europa.eu, Fabienne.van-Raemdonck@ec.europa.euIssueThe AT CA would like to ask MS to provide comments and invite the Commission to further explore and clarify the scope of the exemption for cosmetics set out in Article 1(5)(c) of the CLP Regulation in the borderline case of pure essential oils placed on the market for cosmetic purposes (and not as an additive to cosmetic products). The issue here concerns three questions Whether and on what conditions (pure) essential oils could fall under the definition of cosmetic products in Regulation (EC) No. 1223/2009 (to be solved by the Working Group for Cosmetic Products)?If supplier (manufacturer) of products can choose the applicable legal framework (CLP or Cosmetic Products Regulation) by making claim of “exclusively or mainly” cosmetic purposes on pure subjective grounds? Whether and on what conditions (pure) essential oils, if considered cosmetic products, fall under the scope of exemptions in Article 1(5)(c) of the CLP Regulation for cosmetic products in their “finished state" for use of "final user”?MotivationLately more and more suppliers from EU MS and third countries neither label nor apply childproof fastenings to their products with reference to the exemption from CLP for cosmetic products. On their labels they recommend professional and private end users to mix essential oils with massage oil or water and even directly apply them on the skin claiming mainly cosmetic purposes (as bath additive, massage oil additive, aroma therapy, etc). The substances in the essential oils, however, are in almost all cases classified into different hazard categories in the C&L inventory. And many suppliers claim those cosmetic purposes only with the intention to avoid proper CLP labelling. The competent authorities in MS for cosmetics usually decide on a case to case basis, if a specific essential oil falls under the definition of cosmetic product. It is common knowledge that some of these oils may be harmful to consumers, especially when swallowed (by children), inhaled, in direct contact with skin or eyes, or even only if added to cosmetic products due to their transdermal absorption or inhalation. In our view the interpretation of the exemptions of this Regulation as regards cosmetics has not been harmonised so far in view of pure essential oils placed on the market for cosmetic purposes. This creates a serious distortion of the market. In addition, given the hazardous properties of those products, pure essential oils with hazardous properties, which are not labelled according to CLP, present a serious hazard to workers and consumers, especially children.BackgroundECHA describes an essential oil as a volatile part of a natural product, which can be obtained by distillation, steam distillation or expression in the case of citrus fruits. It contains mostly volatile hydrocarbons. Essential oils are derived from various sections of plants and liquid at room temperature. The oil is "essential" in the sense that it carries a distinctive scent, or essence of the plant. They have a high refraction index and most deviate polarised light. Their density is generally lower than that of water. They are soluble in lipids and common organic solvents and can be distilled with steam. Essential oils are very sparingly soluble in water.Essential oils have become an integral part of everyday life. They are used in a great variety of ways from flavouring agents to the essence of cosmetic products. Recent trends show a growing use of pure essential oils in spices, tea, steam baths and sauna, inhalation, fragrance lamps, massage oils, balms. Many aroma therapists and laymen consider natural essential oils to be completely safe. This is based on the misconception that all herbs are safe because they are natural. The toxicity of essential oils can also be entirely different to that of the herb, not only because of their high concentration, but also because of their physicochemical properties. Essential oils, as products of distillation for example, are mixtures of mainly low-molecular-weight chemical substances, which in addition to their lipophilicity, results in an ability to pass across membranes very efficiently. EFEO-/IFRA published Guidelines for the identification of substances and sameness of complex natural substances (NCS) according to REACH- and CLP Regulation. Although essential oils are generally used in a diluted form in cosmetic products, this is not always the case. If products containing high concentrations of essential oils are misused, the effects can be harmful especially in sensitive individuals, such as sensitised individuals and children. This is even truer for pure essential oils (close to 100%). In addition to this, essential oils can have variability parameters which can significantly alter their chemical profile and therefore increase the risk of toxicity. This in turn could influence the quality and safety of the finished cosmetic product. It is therefore important to ensure that defined quality criteria exist for essential oils and are considered by all operators when placing such cosmetic products on the market.Legal BasisArticle 1(5)(c) of the CLP Regulation provides that:This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:[…](c) cosmetic products as defined in Directive 76/768/EEC;[…]Cosmetic products are defined in Regulation (EC) No. 1223/2009 as “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”.According to Cosmetic law it is possible to decide on a case to case basis, that in one case a specific essential oil is considered a cosmetic product and in other cases not, depending on the user information on the label. Currently there is no specific legal basis or guidance that would justify a general decision. Traditionally bathing additives or massage oils (usually mixtures of several ingredients incl. essential oil) have always been identified and labelled only as cosmetic products. But Pure Essential Oils – whether intended for professional or consumer end uses - always require mixture in water or oil, before used as a cosmetic in bathing additives, massage oil, aroma therapy etc. There is no legal basis or guidance if pure essential oils are considered cosmetic additives and therefore chemical substances that require labelling according to CLP or if they can fall under the definition of cosmetics.AnalysisRecently suppliers of pure essential oil recommend the use as bathing and massage oil additive (eg “mix 3 drops with 10ml almond oil and add to bathing water”) on the label. The pure essential oil would serve as cosmetic product after mixing with other additives (water/oil) or premixtures. It is highly unlikely to almost unthinkable that pure essential oils could be assessed as safe in accordance with Regulation 1223/2009 for direct contact with skin. Nevertheless, some manufacturers and suppliers claim that their products serve only or mainly cosmetic purposes as bathing and massage oil (omitting other obvious purposes like room scenting) and therefore are exempted from CLP. In other cases, the same essential oils are claimed to serve non-cosmetic but room or sauna scenting purposes and are subject to CLP. In this regard, ECHA published a FAQ, which was agreed in 2015 with national helpdesks: “Similarly to other exempted substances and mixtures referred to in CLP Article 1.5 which are in the finished state and intended for the final user, substances and mixtures in the form of cosmetic products as defined in Directive 76/768/EEC on the whole are exempted from the provisions of CLP. […] Note that a manufacturer, importer or downstream user (formulator) who supplies a substance or mixture which is not yet in the finished state is obliged to classify, package and label it in accordance with CLP. […]”The terms "finished state" and "final user" are not defined in CLP, though related terms are. The CLP Regulation aims to protect workers, consumers and the environment by labelling that reflects a particular chemical's possible hazards, except when sectorial legislation lays down more specific rules on classification and labelling. To us, it is important to define what “finished state” and “intended for the final user” mean for cosmetic products, considering:The intentions of the legislation (CLP/GHS);The need to protect consumers, workers and the environment when handling hazardous substances and mixtures;The absence of suitable and more specific rules in the cosmetics legislation;The companies’ social responsibility; The discussion on the scope of exemption from CLP found in Article 1(5)(e) CLP for food and feeding stuff, feed additives and premixtures, The majority of the intervening CARACAL members and COM were in favour of the narrower second interpretation of “in the finished state, intended for the final user“ Doc CA/93/2015 COM concluded as follows: Feeding stuffs intended to be used by the final users to feed directly animals such as compound feeding stuffs would be exempted from the CLP requirements;Feeding stuffs in the finished state but not intended for the final user (not directly fed to animals since further manipulation/alteration is necessary such as additives and premixtures) would be subject to CLP. Therefore, CLP labelling would apply to feeding stuffs not directly fed to animals, even if only water needs to be added or the feeding stuff would need to be mixed with other components. This would however not apply to complementary feeding stuff, which although not sufficient for a daily ration, could in principle be directly fed to animals (for more explanation on this point see response to comments in annex).We would like to ask MS and COM if they agree that this narrower interpretation of “in the finished state, intended for the final user“ should apply to the scope of the exemption from CLP found in Article 1(5)(c) CLP for cosmetic products. Following this line, we conclude the following implications:Cosmetic products in the finished state, intended for the final user directly ?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” of the final user “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” (such as compound bathing additives or compound massage oils containing essential oils) would be exempted from the CLP requirements; Cosmetic products in the finished state but intended for the final user (not directly) “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” without prior manipulation/alteration or mixing with other components would be subject to CLP (e.g. additives and pre-mixtures). This brings us to the special cases of two types of “cosmetic kits”, which have been discussed in the Manual of the Working Group on Cosmetic Products (Sub-Group on Borderline Products). According to the Sub-Group on Borderline Products CLP does not apply to so-called multi-component cosmetic products (Type 1 kits) with components to be mixed based on clear instructions […]”, while “kits of substances and mixtures, which are not linked to specific instructions on how to make the finished cosmetic product from them, and where the components are not cosmetic products on their own” (Type 2) are subject to CLP. If we follow the “narrow interpretation” approach taken by CARACAL in the case of feed additives (see above), it would follow that CLP applies to all substances or mixtures, which cannot directly be placed in contact with the external parts of the human body (epidermis, hair system, etc). Thus, CLP could apply (in addition to cosmetic law) to even to the individual components that are registered, labelled and packaged in accordance with Regulation No. 1223/2009, because according to CLP they would not be “in their finished state” and “intended for the final user”. Nevertheless, in any case the opposite conclusion should not be drawn from this and components of cosmetic kits, that do not fall under the scope of exemption from CLP, should also remain within the scope of the cosmetic products Regulation.ConclusionTo summarize, it is highly unlikely to almost unthinkable that pure essential oils could be assessed as safe in accordance with Regulation 1223/2009 for direct contact with skin. Therefore, essential oils basically always require mixing with oil/water/other components before direct application to skin/human body in massage, sauna, and aroma therapy or as a bathing additive. It follows, that (pure) essential oils that are placed on the market for the final user are always subject to CLP because they are not considered a cosmetic product in the finished state - regardless whether they are labelled as cosmetic product or part of a cosmetic kit. On the other side, readymade mixtures with essential oils, such as bathing additives/massage oils, would not be subject to CLP and cosmetic kits as such (e.g. almond oil and essential oils in one package), would not be subject to CLP while the individual component (if not a cosmetic product by itself) would be subject to both CLP and the Cosmetics Regulation. This approach would result in the consistent application of CLP labelling and child-resistant fastening to all (pure) essential oils, regardless their intended or claimed use as cosmetic product.Action Requested and Next StepsCaracal members are invited to co-ordinate with the Member States Competent Authorities for cosmetic products and comment on the above interpretations. We suggest the matter to be presented and discussed at the Standing Committee on Cosmetics on their next meeting. Input should be received from the relevant industry associations. As a result of the discussions ECHA should be requested to amend the Q&A No 0181 and draft a new Q&A regarding essential oils based on the outcome of discussions in CARACAL. The draft Q&A should be presented to Caracal members, as well as to the Standing Committee/Working Group on Cosmetic Products. Publication of the Q&A should take place ideally in the third/fourth quarter of 2017 in order to allow for sufficient time for the implementation by small economic operators. CA AustriaVienna, 7th March 2017 ................
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