EUROPEAN COMMISSION
ENVIRONMENT DIRECTORATE-GENERAL
Circular Economy and Green Growth
Sustainable Chemicals
DIRECTORATE-GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES
Consumer, Environmental and Health Technologies
REACH
Chemicals
Brussels, 07/03/2017
Doc. MSCA/08/2017
23rd Meeting of Competent Authorities for REACH and CLP (CARACAL)
Open Session
Room: 1A Centre Albert Borschette
Rue Froissart 36
1040 Brussels, Belgium
Concerns:
AT paper on Clarification on scope exemptions of Regulation (EC) No 1272/2008
for pure essential oils used as cosmetics – problem description and possible
solution
Agenda Point:
CLP point 24
Action Requested:
For information and discussion.
Written comments on this document should be sent by 24 April 2017 to [email protected], [email protected], [email protected]
1
Issue
The 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
1) 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)?
2) 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?
3) 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”?
Motivation
Lately 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.
Background
ECHA 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 plant1. 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 oils2 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
1
ECHA, Substance Identification, Sector-specific support for substance identification, Essential Oils
https://echa.europa.eu/support/substance-identification/sector-specific-support-for-substance-identification/essential-oils
2 Definition of an essential oil, adopted by the Commission of the European Pharmacopoeia [European Pharmacopoeia :
Essential oils], which is very similar to that of the International Organisation for Standardisation ISO 9235:2013 standards on
aromatic natural raw ingredients [ISO 9235:2013; Aromatic natural raw materials - vocabulary], is an: ‘Odorous product,
usually with a complex composition, obtained from a botanically defined plant raw material by steam distillation, dry
2
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 Regulation3.
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 Basis
Article 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. 1223/20094 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.
Analysis
Recently 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
distillation, or a suitable mechanical process without heating. Essential oils are usually separated from the aqueous phase by
a physical process that does not significantly affect their composition.’
3 http://efeo-org.org/wp-content/uploads/2015/08/EFEO-IFRA-Guidelines-NCS-SID-REACH-CLP-Version-5-August2015.pdf
4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products,
OJ L 342 of 22 December 2009, p. 59.
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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. […]5”
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 majority of the intervening CARACAL members and COM7 were in favour of the
narrower second interpretation of “in the finished state, intended for the final user“8
The discussion on the scope of exemption from CLP found in Article 1(5)(e) CLP for food and
feeding stuff, feed additives and premixtures6,
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.
5
ECHA FAQ 0181, Modified Date: 04/06/2015, Version: 1.0, This answer has been agreed with national helpdesks, link to
website.
6
The definitions are found in Article 2: "feed additives" means substances, micro-organisms or preparations, other than feed
material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the
functions mentioned in Article 5(3); "premixtures" means mixtures of feed additives or mixtures of one or more feed
additives with feed materials or water used as carriers, not intended for direct feeding to animals.
7 See CARACAL Docs CA/18/2015, CA/46/2015 and CA/93/2015.
8 First interpretation - Under the first interpretation set out in CA/18/2015, the concept of "in the finished state, intended for
the final user" is understood broadly. It would include additives and premixtures that are prepared by one user, but could still
be subject to further operations by a subsequent user who may, for example, add water or mix the additive with feed. In this
sense additives and premixtures in the finished state and covered by Art. 1(5)(e) would be exempted from CLP requirements.
It should be noted that feed additives may not be placed on the market, processed or used unless they comply with the
authorisation, labelling and packaging requirements found in Regulation 1831/2003.
Second interpretation - Under the second interpretation, "in the finished state, intended for the final user" is interpreted
more narrowly. Drawing a parallel with the definition of "final consumer" found in Regulation 178/2002, this interpretation
suggests that a feed additive or premixture is only in its finished state, intended for the final user, when it is ready for direct
oral feeding to animals. However, in accordance with Regulation 1831/2003 Art. 2(a) and (e), both feed additives and premixtures cannot be used directly to feed animals. Therefore, CLP applies to all additives and pre-mixtures, including those
authorised, labelled and packaged in accordance with Regulation 1831/2003.
4

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 kits9”, which have been discussed in the Manual of
the Working Group on Cosmetic Products (Sub-Group on Borderline Products)10. 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.
1223/200911, 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.
Conclusion
To 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
NOTE: A “kit” usually contains parts, tools and instructions.
Manual of the Working Group on Cosmetic Products (Sub-Group on Borderline Products) on the scope of Application of
the Cosmetics Regulation (EC) No 1223/2009 (Art. 2 (1)A), p.29, Ref. Ares(2017)75824-06/01/2017. “3.5.4 Cosmetic Kits,
207. Question: Are cosmetic kits cosmetic products? 208. Answer: There are several types of cosmetic kits: 1. Kits with
components to be mixed based on clear instructions, e.g. soap chips to be mixed with a colouring mixture and a fragrance
mixture, or a cream base to be mixed with a perfuming mixture, are considered as finished cosmetic products. Therefore, the
cosmetics legislation applies, and the kits must be assessed, labelled, notified, etc. by the responsible person as multicomponent cosmetic products. The CLP Regulation does not apply because of an exception for finished products in the form
of cosmetics. If the consumer is supposed to add any ingredient that is not in the kit (e.g. water or honey), to the “recipe”,
this should be taken into account by the responsible person in complying with the Cosmetics Regulation. 2) Kits of substances
and mixtures, which are not linked to specific instructions on how to make a finished cosmetic product from them, and where
the components are not cosmetic products on their own, are not cosmetics. For these kits, the CLP Regulation applies to the
components. If the substances and mixtures are then mixed and placed on the market as finished cosmetic products, the
cosmetic legislation applies and the manufacturer becomes a responsible person.”; Source:
https://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products_en
11 Note: Cosmetic Products do not require authorisation from the competent authority before their placing on the market.
9
10
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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 Steps
Caracal 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 Cosmetics12 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 Austria
Vienna, 7th March 2017
12
Working Group on Cosmetic Products (E01302), [email protected];
http://ec.europa.eu/growth/sectors/cosmetics,
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