Requirements in relation to qualifications of Safety Assessors of Cosmetic Products
Cosmetic products on the market in Ireland are governed by the Regulation (EC) No. 1223/2009 on cosmetic products (the EU Regulation) and, nationally, by the European Union (Cosmetic Product) Regulations 2014, S.I. 440 of 2013.
Article 10 of the EU Regulation requires the completion of a safety assessment for each cosmetic product placed on the market in the European Union (EU)/European Economic Area (EEA). Article 10 (2) requires:
The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
Furthermore, Commission Implementing Decision on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2013/674/EU) requires:
A person who has obtained qualifications in a third country may act as a safety assessor if they have completed ‘a course recognised as equivalent [to a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline] by a Member State’.
Proof is to be provided of the safety assessor’s qualification (i.e. copy of the diploma and, where needed, proof of equivalence) laid down in Article 10 of Regulation (EC) No 1223/2009.
The Responsible Person (RP) for the cosmetic product should ensure that the Safety Assessor is suitably qualified and this should be appropriately justified and demonstrated in Part B of the Cosmetic Product Safety Report (CPSR) as outlined above.
Nationally, Regulation 6 of S.I. 440 of 2013, “Qualifications of person carrying out cosmetic product safety assessment” states:
In carrying out its function, under Article 10(2) of the EU Regulation, of assessing whether persons carrying out a cosmetic product safety assessment, are in possession of evidence of formal qualifications awarded on completion of a course equivalent to one of the courses referred to in that provision, the Board shall assess the evidence on a case by case basis, having regard to the course content and the experience of the person concerned.
For cosmetic products where the RP is located in Ireland, the HPRA assesses the qualification of safety assessors on a case-by-case basis, for example during the CPSR review, considering both the formal qualification and the relevant experience of the safety assessor.
For safety assessors who have received their university qualification(s) from a country outside the EU/EEA, please note the QQI (Quality and Qualifications Ireland) is an independent State agency responsible for promoting quality and accountability in education and training services in Ireland. Hosted by QQI, NARIC (National Academic Recognition Information Centre) Ireland provides advice on the recognition of foreign qualifications in Ireland. Safety assessors should utilise the QQI website, for example the Qualifications Database tool, to obtain a comparability statement for their formal university qualification. It should be ensured the qualification is considered comparable to a university course in Ireland of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline. This statement should be included in Part B of the CPSR, along with evidence of the formal qualification received from the university outside the EU/EEA. It should be noted, the HPRA may review this and the relevant experience of the safety assessor during a CPSR review at a later date.
If a safety assessor who has received their university qualification from a country outside the EU/EEA, having consulted NARIC Ireland, ascertains their university course is not considered comparable to that of an equivalent course in Ireland, and they are currently acting as a safety assessor for a cosmetic product where the RP is established in Ireland, they should contact the HPRA without delay at firstname.lastname@example.org.
Safety assessors of cosmetic products where the RP is established in another EU member state, should refer to the competent authority in that member state for guidance on this topic. The contact details of the authorities are available on the European Commission website.