(1)

On 10 January 2018, the Commission adopted Commission Regulation (EU) 2018/35 (2) restricting the placing on the market of octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’) in wash-off cosmetic products. This restriction was inserted as entry 70 of Annex XVII to Regulation (EC) No 1907/2006.

(2)

On 13 June 2018, D4, D5 and dodecamethylcyclohexasiloxane (‘D6’) were identified by the Member State Committee (‘MSC’) of the European Chemicals Agency (‘the Agency’) as substances of very high concern (‘SVHC’) with very persistent and very bioaccumulative (‘vPvB’) properties. D4 was identified as having persistent, bioaccumulative and toxic (‘PBT’) properties. D5 and D6 were also identified as having PBT properties when they contain 0,1 % or more by weight of D4.

(3)

When the Agency’s Risk Assessment Committee (‘RAC’) assessed the proposal of a restriction to the placing on the market and use of D4 and D5 that was ultimately adopted in Regulation (EU) 2018/35, it did not exclude a potential risk from their use in leave-on cosmetic products. For this reason, on 15 December 2016, the Commission requested (3) the Agency to prepare a dossier pursuant to Article 69(1) of Regulation (EC) No 1907/2006 (the ‘Annex XV dossier’), with a view to a potential restriction of D4 and D5 in leave-on cosmetic products and other consumer and professional products. On 5 February 2018, the Commission requested (4) the Agency to include D6 in the Annex XV dossier.

(4)

On 20 March 2019, the Agency submitted the Annex XV dossier (5), which demonstrated that action on a Union-wide basis is necessary to address the risks to the environment posed by the use of D4, D5 and D6 when discharged into environmental compartments.

(5)

On 28 November 2019, RAC adopted its opinion (6), confirming that the hazard properties of D4, D5 and D6 give rise to specific concerns for the environment when present in consumer and professional products that end up released into both the aquatic and the atmospheric compartments.

(6)

RAC concluded that total releases of D4, D5 and D6 into the environment should be used as a proxy for risk. RAC also concluded that consumer and professional uses of leave-on cosmetic products and other consumer and professional products containing D4, D5 and D6 result in releases to the environment, with the wide-dispersive uses in cosmetic products constituting the main source of releases. RAC agreed with the Agency’s assessment in the Annex XV dossier that the risk is not adequately controlled and that emissions of these vPvB and PBT substances are not minimised through their life cycle, as required in paragraph 6.5 of Annex I to Regulation (EC) No 1907/2006.

(7)

RAC also concluded that the proposed restriction is targeted and the most appropriate Union-wide measure to minimise the emissions caused by leave-on cosmetic products and other consumer and professional products and to address the identified risk in terms of its effectiveness in reducing that risk, its practicality, and the manner in which it can be monitored.

(8)

On 12 March 2020, the Agency’s Socio-Economic Assessment Committee (‘SEAC’) adopted its opinion (7), indicating that the proposed restriction, as modified by RAC and SEAC, is the most appropriate Union-wide measure to reduce the emissions of D4, D5 and D6 to the environment in terms of its socioeconomic benefits and costs.

(9)

SEAC concurred with the conclusions in the Annex XV dossier for a general deferral of two years of the application of the restriction.

(10)

SEAC also concurred with longer deferrals for a number of specific uses. Based on the time required for substitution, SEAC agreed with a deferral of five years for leave-on cosmetic products and medical devices. As likely alternative substances or technologies would not result in an overall reduction of the risk, SEAC also agreed with a deferral of the restriction of the use of D5 as a solvent in the dry cleaning of textiles, leather and fur of 10 years. As regards medicinal and veterinary products, SEAC supported a seven-year deferral of the restriction. This seven-year deferral takes into account the time necessary to substitute the use of D4, D5 and D6 in medicinal and veterinary products with alternative substances or technologies, as well as the time needed for qualification and registration of such products.

(11)

SEAC also concurred with a number of derogations proposed in the Annex XV dossier. SEAC agreed with the derogation for the placing on the market of D5 and D6 for use in devices for the treatment and care of scars and wounds, the prevention of wounds, and the care of stoma. SEAC also agreed with the derogation for the placing on the market of D5 for professional use in the cleaning or restoration of art and antiques, and with the inclusion of a clearer description of the activities on industrial sites to which the restriction to the placing on the market of D4, D5 and D6 is not to apply. SEAC concurred with the derogation for the placing on the market and the use of D5 as a solvent in dry cleaning systems of textile, leather and fur, under certain conditions.

(12)

Based on information on uses in mixtures and on enforcement considerations, SEAC concurred with the suggested clarifications and further derogations proposed in the Annex XV dossier for certain mixtures that contain D4, D5 and D6 as residues from silicone polymers.

(13)

The Agency’s Forum for Exchange of Information on Enforcement, referred to in Article 76(1), point (f), of Regulation (EC) No 1907/2006, was consulted during the restriction procedure and the Commission has taken its recommendations into account.

(14)

On 25 May 2020, the Agency submitted the opinions of RAC and SEAC to the Commission.

(15)

The Commission concludes that there is an unacceptable risk arising from the emissions of D4, D5 and D6 from consumer and professional products and that the restriction proposed by the Agency, with the changes suggested by RAC and SEAC, is the most appropriate Union-wide measure to address that risk.

(16)

The Commission concurs with the conclusion, in RAC’s and SEAC’s opinions, that the proposed restriction is complementary and provides a logical extension to the existing restriction on the placing on the market of D4 and D5 in wash-off cosmetic products, contained in entry 70 of Annex XVII to Regulation (EC) No 1907/2006. In the interest of legal certainty and for ease of reading, that entry should be replaced in its entirety.

(17)

Stakeholders should be allowed sufficient time to take appropriate measures to comply with the proposed restriction. The Commission therefore proposes a general deferral period of two years, and longer deferral periods for specific uses. The Commission also concurs with the need for derogations for a number of specific uses.

(18)

As regards the deferral period for cosmetic products other than wash-off cosmetic products, the Commission notes the high emissions from that product group and the conclusion by RAC that for vPvB and PBT substances, the length of the transitional period is the most critical element from a risk point of view, as more emissions occur the longer the transitional period is. Consequently, emissions of vPvB and PBT substances into the environment should be minimised with a short transitional period. The Commission also notes the significant costs to industry to reformulate a high number of cosmetic products other than wash-off cosmetic products per year. In view of the cost-effectiveness of the proposed restriction for cosmetic products other than wash-off cosmetic products and the need to balance a high protection of human health and the environment with the minimisation of socioeconomic impacts, the Commission concludes that a three-year deferral period for those products is appropriate.

(19)

As regards the deferral period for medical devices as defined in Article 1(4) of Regulation (EU) 2017/745 of the European Parliament and of the Council (8), taking into account concerns from the sector and some Member States on the estimated time for redesign steps, namely to find an alternative, to perform a qualification process and to seek registration of a newly designed mixture according to Regulation (EU) 2017/745, the Commission considers appropriate to grant a 7-year deferral period to these devices. Moreover, D4 and D5 may be found at concentrations above 0,1 % in some in vitro diagnostic devices (IVD) as defined in Article 1(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council (9). As substitution in IVD presents similar concerns, it is appropriate to give these devices the same deferral period.

(20)

The use as a laboratory reagent in research and development activities should only be exempted if taking place under controlled conditions as referred to in Article 3(23) of Regulation (EC) No 1907/2006, without being limited to 1 tonne per year.

(21)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(22)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133(1) of Regulation (EC) No 1907/2006,