By Dr. Frédéric Lebreux, BIORIUS
The SCCS Opinion
On March 25, 2015, the Scientific Committee on Consumer Safety (SCCS) published a draft Scientific Opinion concluding that the use of D5 in cosmetic products is safe except:
- When used in body lotions and hair styling formulations and in those product forms that can give rise to lung exposure of the consumer through inhalation, e.g. aerosols, pressurized sprays, powders, etc.
- When it contains more than 1% of D4 (Cyclotetrasiloxane), which is classified as a reprotoxic substance in the EU.
These conclusions were submitted for public consultation and the Cosmetic Industry strongly reacted. As a consequence, and based on additional safety data, the SCCS revised its Scientific Opinion. The final version was adopted on July 29th and published a few days later on the SCCS website (SCCS/1549/15). It now concludes that the use of D5 in cosmetic products is safe except:
- When used in hair styling aerosols and sun care spray products.
- When the level of D4 is ‘too high’. Therefore, the level of impurity of D4 as an impurity of Cyclopentasiloxane (D5) should be kept as low as possible.
The revision of this Opinion is a good news as it maintains the use of D5 in body lotions. Furthermore, the final Opinion is less stringent regarding the tolerated level of D4 as an impurity of D5, leaving a bit more flexibility for the management of these traces.
This Opinion should be transposed into the legislation, which always takes a lot of time. It would be premature to estimate a date for the publication of an amendment to the Cosmetics Regulation. However, two to three years is the average period of time necessary for such a regulatory development.
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The ECHA Restriction
On March 11, 2016 the European Chemical Agency (ECHA) Risk Assessment Committee (RAC) and ECHA Socio-economic Analysis Committee (SEAC) released a joint report in which they both agreed that the restriction proposal of D4 and D5 at 0.1% in wash-off products submitted by the UK is appropriate (leave-on products and wipes are out of the scope of this development).
A public consultation took place and the Cosmetic Industry submitted many comments against this regulatory development. Based on this input, RAC and SEAC made some modifications and clarifications to the justification of a Joint Opinion but adopted it mainly unchanged in June. Furthermore, RAC and SEAC confirmed their view that the restriction of the use of D4 and D5 in "wash-off" personal care products should be effective two years after publication in the official journal. In my opinion, it is very likely that this restriction of D4 and D5 at 0.1% in wash-off products will be implemented.
The two Opinions of the ECHA Committees contribute to the decision of the European Commission, who will then take a balanced view of the identified risks and of the benefits and costs of the proposed restriction. Within three months of receipt of the two Committees' Opinions, the Commission will provide a draft amendment of the list of restrictions in Annex XVII of REACH. The final decision is taken in a comitology procedure with scrutiny involving the Member States and the European Parliament. The full process usually takes one to two years before a publication of an amendment to the REACH Regulation. Then, and as proposed by the RAC and the SEAC, the transition period for implementing this restriction once the legislation is amended should be two years.
Fred Lebreux holds a Ph.D. in organic chemistry and a master in management. After a post-doctoral position at the Ecole Polytechnique in Paris where he developed new pathways for the synthesis of biologically active substances, he was hired by IFRA, the International Fragrance Association. After a few years at the position of IFRA Scientific and Regulatory Manager, he was promoted IFRA Scientific Projects Manager. In both positions, Fred actively contributed to defend the collective interests of the global fragrance industry.
After 5 years with IFRA, Fred joined BIORIUS at the position of Scientific and Regulatory Director. At BIORIUS, the leading consultancy company in scientific and regulatory services for the Cosmetic Industry, he developed further the competences of his team, ensured the quality of deliveries, improved important processes, created effective working relationship with Biorius’ clients and solved complex issues.
In October 2015, the Board of BIORIUS nominated Fred Lebreux as the new Chief Operating Officer, entrusting him the daily operations of the company. In his new role, Fred took over the global supervision of the Department of Operations and the Department of Scientific and Regulatory affairs and will contribute to strengthen their current organization.
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