What’s happening?

What’s happening? Here is an update for December 2024:

EU REACH: new substance on Candidate List
EU REACH: new commissioner committed to revision
Focus on cosmetics: tea tree oil

EU REACH: new substance on Candidate List

Triphenyl Phosphate (CAS number 115-86-6) is now on the Candidate List of substances of very high concern (SVHC) for Authorisation.

The substance is an endocrine disruptor and is used as a flame retardant and as a plasticiser in polymer formulations, adhesives and sealants.

The list currently contains 242 entries for hazardous chemicals, some of them are groups so the actual number of substances is higher.

What does it mean for companies?

European producers, importers and suppliers of products containing Candidate List substances must:

inform their customers of its presence, provide sufficient information on safe use, and notify the European Chemicals Agency (ECHA) – under the REACH Regulation
notify ECHA’s database of substances of concern in products (SCIP), if the articles they produce or import contain SVHCs in a concentration > 0.1% weight by weight – under the Waste Framework Directive, and
Products containing SVHCs cannot have the ecolabel award – under the Ecolabel Regulation

The substance may be placed on the Authorisation List in the future. If so, its use will be prohibited unless a company obtains authorisation for its use from the European Commission.

EU REACH: new commissioner committed to revision

On 6 November 2024, the Swedish EU minister Jessika Roswall was approved as EU Commissioner for Environment, Water Resilience and a Competitive Circular Economy.

The new College of Commissioners took office on 1 December.

For the next five years, she will oversee chemicals policies, including the long-awaited REACH revision within a chemicals industry package, and has committed to moving forward with it in 2025.

The European Commission’s new chemicals industry package, which includes the revision of REACH, will strive to revamp and streamline the regulatory framework to remove harmful substances from the marketplace, while providing greater long-term investment certainty and reduced burden for European chemical companies.

The new Commission also maintains the commitment to banning Per- and polyfluoroalkyl substances (PFAS).

To provide some clarity and predictability, the Commissioners-designate highlighted focusing on banning the consumer uses of PFAS: for example, in cosmetics, food contact materials and outdoor clothing.

Read more in the recent H2 Compliance article.

Focus on cosmetics: tea tree oil

Tea tree oil (melaleuca alternifolia), which is known to have skin conditioning, insecticidal, repellent and anti-bacterial properties, is used extensively in cosmetics and personal care products.

It is comprised of over 100 chemicals and is a substance of unknown/variable composition, complex reaction products or of biological materials (UVCB).

The European Chemicals Agency (ECHA) has recommended tea tree oil extract for harmonised classification and labelling (CLH) as a category 1B reproductive toxicant.

If adopted, classification as a hazard of highest concern in the EU regulations will make its eventual removal from the European cosmetics market likely.

Companies would need to remove or reformulate the affected products from the market within 15 months.

Suppliers of tea tree oil may submit a safety dossier to the EU Scientific Committee on Consumer Safety (SCCS) to apply for a justified exemption.

Any regulations against tea tree oil will likely have a knock-on effect for other essential oils and other naturally complex substances. The designation of these oils as complex natural substances will have to change as the EU moves from risk-based to hazard-based assessment of chemicals.

Cosmetic products are under scrutiny in the EU following the recent enforcement project report, which found that 6% of inspected cosmetic products contained hazardous substances banned under the POPs and REACH regulations.

The European Commission has also announced that it will move forward with the revision of the Cosmetics Regulation to achieve better alignment with REACH.

Read more in the full article on the H2 Compliance website.

H2 Compliance monitors these developments. Please contact the team if you have cosmetics or personal care products in your portfolio.