Case C‑13/17

Fédération des entreprises de la beauté

v

Ministre des Affaires sociales, de la Santé and des Droits des femmes and Others

(Request for a preliminary ruling from the Conseil d’État (France))

(Reference for a preliminary ruling — Approximation of laws — Cosmetic products — Regulation (CE) no 1223/2009 — Article 10(2) — Assessment of the safety of cosmetic products — Qualification of the safety assessor — Recognition of equivalent training courses — Disciplines similar to pharmacy, toxicology or medicine — Member States’ discretion)

Summary — Judgment of the Court (Sixth Chamber), 12 April 2018

1. Approximation of laws—Cosmetic products—Regulation No 1223/2009—Safety assessment of cosmetic products—Qualification of the safety assessor—Obligation on the person responsible for the product to submit proof of that qualification—Scope

   (European Parliament and Council Regulation No 1223/2009, Art. 10(2))

2. Approximation of laws—Cosmetic products—Regulation No 1223/2009—Safety assessment of cosmetic products—Qualification of the safety assessor—Recognition of equivalent training courses—Possibility of recognising training courses delivered both in Member States and in third countries

   (European Parliament and Council Regulation No 1223/2009, Art. 10(2))

3. Approximation of laws—Cosmetic products—Regulation No 1223/2009—Safety assessment of cosmetic products—Qualification of the safety assessor—Recognition of equivalent training courses—Disciplines similar to pharmacy, toxicology or medicine—Member States’ discretion—Limits

   (European Parliament and Council Regulation No 1223/2009, Art. 10(2))

1.  See the text of the decision.

   (see paras 24-27)

2.  Article 10(2) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products must be interpreted as meaning that the recognition of equivalence of courses, laid down in that provision, can cover courses other than those delivered in third countries.

   It is apparent from the very wording of that provision that the recognition of equivalence by a Member State, for the purpose of that provision, must relate to a course that is considered to be equivalent to a university course of theoretical and practical study in either pharmacy, toxicology or medicine, or a similar discipline. The EU legislature thus made the recognition of equivalence laid down in Article 10(2) of Regulation No 1223/2009 subject to requirements relating, first, to the level of the courses concerned and, second, to the category of the subjects taught during those courses. As the Advocate General observed in point 31 of his Opinion, that provision, in the light of its wording, allows account to be taken not only of the great diversity of the appropriate courses of study that already exists, but also of the way in which those courses may yet develop.

   Furthermore, it must be stated that Article 10(2) of Regulation No 1223/2009 does not contain any indication as to the place where diplomas or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study or the qualification recognised as equivalent were obtained. It follows that training courses delivered both in third countries and in Member States may be recognised as equivalent to such a university course.

   (see paras 31-35, 43, operative part 1)

3.  Article 10(2) of Regulation No 1223/2009 must be interpreted as conferring on each Member State the power to determine disciplines that are ‘similar’ to pharmacy, toxicology or medicine, as well as levels of qualification satisfying the requirements of that regulation, on condition that it complies with the objectives laid down by that regulation, consisting, in particular, in guaranteeing that the person entrusted with the assessment of the safety of cosmetic products has a qualification that enables him to ensure a high level of protection of human health.

   As regards specifically the question of whether a discipline can be regarded as ‘similar’ to pharmacy, toxicology or medicine, it must be stated, as the Advocate General observed in points 65 and 66 of his Opinion, first, that the Member States must verify the existence of a common body of scientific knowledge that is indispensable in order to assess, with the greatest certainty possible, the safety of a cosmetic product, in so far as concerns not only its ingredients, but also the finished product itself and, second, that the objective consisting in ensuring a high level of protection of human health cannot be properly attained unless that common body of knowledge includes both knowledge of the human body and its pathologies and knowledge of the substances used in the manufacture of cosmetic products and their physical and chemical properties.

   (see paras 50, 51, operative part 2)