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REACH and Royal Decree 85/2018: technical session on regulatory affairs at Beauty Cluster Barcelona

27 March 2018 | Cosmetics, Training

REACH y Real Decreto 85/2018

Beauty Cluster Barcelona organised an event last Wednesday, 21 March, in conjunction with SERVIREACH and GTF M. Camps, a seminar on the regulatory developments coming into force in 2018. The cluster, which brings together more than 120 companies from the cosmetics and personal care sector, has organised this session to inform its members about two of the major regulatory changes that will affect the sector in 2018.

On the one hand, the entry into force of the REACH Regulation.  These regulations apply to chemical substances – and, by extension, to cosmetic ingredients that are chemical substances. On the other hand, the very recent publication of the Royal Decree 85/2018, which applies to cosmetic products, and which sets out the areas that the EU permits to be regulated at national level.

The two guest speakers were María Martínez, technical director at SERVIREACH, who spoke about the legal framework governing chemicals; and Mercè Camps, director of GTF, who presented the key changes introduced by the new Royal Decree 85/2018 on cosmetic products.

MCAMPS | REACH y Real Decreto 85/2018: sesión técnica sobre asuntos regulatorios en Beauty Cluster Barcelona

REACH Regulation: updates for the 2018 financial year

Martínez, the technical director of SERVIREACH, opened the session by speaking about Regulation (EC) No 1907/2006 (hereinafter the REACH Regulation). The fact is that 31 May 2018 marks the deadline for registering chemical substances with ECHA. This is a requirement that applies to all companies that manufacture or import chemicals in quantities ranging from 1 to 100 tonnes per year.

Martínez explained to those present the steps to be followed to register and pre-register substances with ECHA, and the documentation required for each substance, in order to comply with the regulations and ensure consumer safety.

Royal Decree 85/2018 on cosmetic products

The second part of the session was led by Mercè Camps. A pharmacist specialising in dermocosmetics and regulatory affairs, she heads the consultancy GTF M. Camps, one of the longest-established healthcare regulatory consultancy firms in Spain.

With regard to the cosmetics sector, the applicable European legislation is Regulation (EC) No 1223/200 on cosmetic products. With the publication of the new Royal Decree 85/2018, those areas in which the EU allows Member States scope for action are restored:

  • Language of labelling
  • Cosmetovigilance
  • Border control
  • Rapex

We would like to congratulate Beauty Cluster Barcelona on organising this session on regulatory matters. We believe it is very important for its members to be familiar with the legal framework governing the cosmetics sector. And we are pleased to have played our part in ensuring they are up to date with the latest developments.

If you would like further information on the new Royal Decree 85/2018 on cosmetics and how it affects your products, please do not hesitate to contact Gabinete Técnico Farmacéutico M. Camps. We will provide you with technical solutions tailored to your needs.

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