The Regulation restricting the use of D4 and D5 in wash-off cosmetics has been published

January 18th, 2018

BIORIUS informed you about the status of the project aiming to restrict the use of Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) in the scope of the REACH Regulation (EC No 1907/2006). With this update, BIORIUS informs you that the related amendment (EU No 2018/35) to the Annex XVII of the REACH Regulation has been published on the 11th of January 2018. This new piece of legislation will get enforced on January 31st, 2018.

As expected, the use restriction of D5 and D4 in wash-off* cosmetic products to a maximum concentration of 0.1% will be implemented. Indeed, D4 and D5 present a risk for the environment and are classified very persistent and very bioaccumulative substances (vPvB). In addition, D4 is toxic and, as reported in IL-045, its use in cosmetic products will be banned in the very short-term.

As expected, a transition period of two years is granted in order to allow cosmetic manufacturers to bring their products into conformity. This means that all wash-off cosmetic products on the EU market will have to contain less than 0.1% of D5 and less than 0.1 % of D4 by January 31st, 2020.

This change is expected to have an important impact on the cosmetic industry. BIORIUS observed that 5.5 % of the wash-off products of its database will be impacted by this project restriction. Your CRM (Customer Relationship Manager) will spontaneously contact you in case some of your products are affected.

Furthermore, the European Commission requested ECHA to investigate on the necessity to restrict the use of D4 and D5 in leave-on cosmetic products. A restriction proposal should be submitted on April 13th, 2018. From this date, the regulatory process may take about two years but it is impossible to determine today whether this regulatory development will lead to a restriction. If so, this one could get enforced in about two years and implemented in about four years.

*”wash-off cosmetic products” means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that under normal conditions of use, are washed off with water after application.

A Ban of Cyclotetrasiloxane (D4) is Expected at Short-Term

July 6th, 2017

The EU Commission just submitted this Regulatory Proposal to the World Trade Organization (WTO), which is one of the latest steps to perform before publishing a new piece of legislation. This consultation at the WTO level allowed BIORIUS to access the annex of this Regulatory Proposal and get the exact list of impacted ingredients.

In addition to the few ingredients already regulated that will change of status, we learned that about 200 other substances will get banned at the same time. The vast majority of these substances are not used in cosmetic products and are simply added for the sake of consistency with the CLP Regulation (EC No 1272/2008). However, there is an exception to the rule and we observed that Cyclotetrasiloxane (D4, CAS 556-67-2) had also been included in this list.

As reported below, Cyclotetrasiloxane also raised environmental concerns and we expected this ingredient to be restricted at maximum 0.1 % in the next few years (first in wash-off products and then, most probably, in leave-on products). Based on the information received today, it seems that the use of Cyclotetrasiloxane in cosmetics will be banned much before.

The consultation period at the WTO level will end on August 27th , 2017. Although this cannot be excluded completely, it is rare that a regulatory proposal is blocked at this stage. By experience, BIORIUS knows that it then takes about 5 months to finalize the legal text and get it published in the Official Journal of the EU. The Regulation is enforced 20 days after its publication. This means that products containing D4 as an ingredient will probably have to be withdrawn from the market by mid of February 2018. As provided for in Article 17, traces of D4 present in cosmetic products as an impurity will remain tolerated.

Important Update on D4 and D5

February 23rd, 2017

As you may know, a project of restriction of Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) has been initiated in 2015 and aims to limit at 0.1% the use of these two ingredients in wash-off^* cosmetic products. These limitations are not related to the EU Cosmetics Regulation (addressing consumer safety issues) but respond to environmental concerns within the scope of the REACH Regulation (EC No 1907/2006).

BIORIUS confirms that these restrictions are very likely to get implemented as the WTO has been notified of this regulatory proposal (and its annex). Notifying the WTO is usually the very last step of a regulatory development and projects of legislation rarely get stopped at this stage. As estimated in IL-015, the amendment of Annex XVII to the REACH Regulation will probably be published in September 2017. Then a transition period of 2 years will start, meaning that all wash-off cosmetic products on the EU market will have to contain less than 0.1% of D5 and less than 0.1 % of D4 by September 2019.

This change is expected to have an important impact on the cosmetic industry. BIORIUS observed that 5.5 % of the wash-off products of its database will be impacted by this project restriction. Your CRM (Customer Relationship Manager) will spontaneously contact you in case some of your products are affected.

*The EU Cosmetics Regulation uses the term ‘’rinse-off’’ for products that are washed off, but including wipe-off products such as baby wipes. As wipe-off products do not normally lead to aquatic emissions it was not considered appropriate to include them within the restriction and therefore the term “wash-off” has been used.

Update on D4 and D5

September 2^nd, 2016

The SCCS Opinion

On March 25th , 2015, the 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 get transposed into the legislation, which always takes a lot of time. This would be speculative to propose 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.

The ECHA Restriction

On March 11th , 2016 the 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 them, RAC and SEAC made some modifications and clarifications to the justification of its joint Opinion but adopted it mainly unchanged mid of 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 enter into force two years after publication in the official journal. 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 Committees1 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.

A Further Step Towards the Restriction of D4 and D5 in Rinse-off Products

April 1st , 2016

With the below article, BIORIUS informed you about the ongoing regulatory developments threatening D4 (Cyclotetrasiloxane) and D5 (Cyclopentasiloxane) when used in rinse-off products. It is important to remind that this dossier is not managed by the Cosmetics Unit of the EU Commission but by ECHA, the European Chemical Agency. The restriction proposal is motivated by environmental concerns and not by human safety issues.

On March 11th , 2016 the ECHA Risk Assessment Committee (RAC) and ECHA Socio-economic Analysis Committee (SEAC) released a joint report in which they both agree that the restriction proposal of D4 and D5 at 0.1% in rinse-off products submitted by the UK is appropriate. At this stage, leave-on products are out of the scope of this development.

The next step of this regulatory process is the public consultation on the draft SEAC Opinion and every interested stakeholder is free to submit comments. The deadline to participate in this public consultation is May 16th , 2016.

It is still too early to determine the outcome of this regulatory development but BIORIUS considers that the likeliness to have these ingredients restricted in D4 and D5 is high. We will continue to update you on this dossier but you can also follow the regulatory process.

Ongoing Regulatory Developments on D4 and D5

July 15th , 2015

With this first Information Letter, Biorius would like to inform you about the current regulatory developments on two ingredients extensively used in the Cosmetic Industry for their skin and hair conditioning properties: Cyclopentasiloxane also called D5¹ and Cyclotetrasiloxane also called D4² . Indeed, these ingredients are on the radar screen of both the ECHA RAC³ and the SCCS⁴ , two important institutions at the center of the regulatory processes affecting the management of cosmetic ingredients in Europe.

The SCCS Opinion

On March 25th, 2015, the SCCS published a Scientific Opinion on D5 (SCCS/1549/15) based on a safety report submitted by the trade association “Cosmetics Europe”. After evaluation of the report, the SCCS concluded that the use of D5 in cosmetic products is safe except for use in body lotion 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. Furthermore, the SCCS reminded that D4 is classified as a reprotoxic substance in Europe and recommended that the level of purity of D5 in the cosmetic products put on the market should be higher than 99% (namely with less than 1% of cyclotetrasiloxane).

1 CAS 541-02-6, EINECS 208-764-9, also named Decamethylcyclopentasiloxane
2 CAS 556-67-2 / 293-51-6, EINECS 209-136-7, also named Octamethylcyclotetrasiloxane
3 Risk Assessment Committee of the European Chemical Agency.
4 Scientific Committee on Consumer Safety.

The ECHA RAC evaluation

On April 17th , 2015, the United Kingdom submitted a restriction proposal to ECHA on D4 and D5. This proposal is motivated by environmental concerns (these ingredients have been found very persistent and very bioaccumulative) and aims to restrict the use of D4 and D5 at a maximum of 0.1% in all rinse-off cosmetic products.
This public consultation on this proposed restriction has started on June 18th , 2015 and the Cosmetic Industry is invited to make scientific comments on the restriction dossier but also to submit socio-economic arguments. The deadline for submitting commentsis December 18th , 2015 and the ECHA RAC evaluation will start right afterwards.