EU Chemicals Agency proposes addition of “very high concern” chemicals to Authorisation List

14 Apr 2023 --- The European Chemicals Agency (ECHA) is proposing to add eight substances to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Authorisation List due to their adverse effects on the health and environment. Once these are added, companies must apply for authorization to continue using them.

“This recommendation brings lead to the same regulatory stage as other lead compounds with similar uses already recommended for inclusion to the Authorisation List,” comments Ofelia Bercaru, director for prioritization and integration at ECHA.

“We are aware of the challenges and consider that balancing the risks posed by lead to workers and the environment with its continued use requires a policy decision by the Commission and EU member states.”

Chemicals in question
The agency explains its choice of substances based on the highest priority.

ECHA proposes adding ethylenediamine, 2-(4-tertbutylbenzyl) propionaldehyde and its individual stereoisomers, lead and glutaral to the Authorisation List, including 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one, 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone, diisohexyl phthalate and orthoboric acid, sodium salt.

They note that including lead in the draft recommendation in February 2022 brought many comments during the consultation. In the discussion, it led to questions on ECHA’s Member State Committee’s timing, combination with ongoing or planned regulatory activities and the expected workload for the industry and authorities.

EC decides which substances should be included in the Authorisation List and what conditions apply to each.Repro-toxic fragrance in question
Chemical 2-(4-tert-butylbenzyl) propionaldehyde and its individual stereoisomers are noted to be toxic for reproduction. Additional concerns include skin sensitization and assessment of endocrine disruption. 

ECHA notes the chemicals’ use as a fragrance in washing and cleaning products, air care products, polishes and waxes.

An individual stereoisomer includes 2-(4-tert-butylbenzyl)propionaldehyde, also used in washing and cleaning products, perfumes and fragrances, cosmetics and personal care products.

Uses in paper-based products
Chemical 2-benzyl-2-dimethylamino-4’-morpholinobutyrophenone is flagged for being toxic to reproduction, damaging to the unborn child and very toxic to aquatic life with long-lasting effects, according to harmonized classification and labeling.

Concerning the personal care applications of the chemical, the substance can be found in products with material based on paper, for instance, tissues, feminine hygiene products and nappies.

Skin and respiratory sensitizer
According to the EU’s harmonized classification and labeling, glutaral is: “fatal if inhaled, is toxic if swallowed, causes severe skin burns and eye damage, is very toxic to aquatic life, is toxic to aquatic life with long-lasting effects, may cause an allergic skin reaction, may cause allergy or asthma symptoms or breathing difficulties if inhaled and may cause respiratory irritation.”

Glutaral is commonly used as a biocide (e.g., disinfectants, pest control products). However, personal care uses include washing and cleaning products.

Lead in question
Although heavy metals such as lead are prohibited in the EU, cosmetics containing the metal can still be found.

“REACH registrations indicate this substance may damage fertility or the unborn child, causes damage to organs through prolonged or repeated exposure, is very toxic to aquatic life with long-lasting effects, may cause cancer, is very toxic to aquatic life and may cause harm to breast-fed children,” underscores ECHA.

Moreover, UK national regulator, the Office for Product Safety & Standard, carried out a study inspecting heavy metal impurities in cosmetic products. “Significant levels of heavy metals including arsenic, antimony and mercury were found to be present, particularly in eye shadow and lip liner products.”Authorization List aims at promoting the substitution of substances of very high concern.

“Where arsenic, antimony, mercury and lead were detected, the lead content was significant with 13 out of 91 samples having a lead content greater than 2 mg/kg, four out of 91 samples having a lead content greater than 5 mg/kg. However, no samples had a lead content greater than 10 mg/kg.”

In related news, the Washington State Senate passed restrictive legislation to ban per- and polyfluoroalkyl substances, lead, phthalates, formaldehyde and formaldehyde releasers and other harmful chemicals used in cosmetics and personal care products in the US state.

Orthoboric acid, sodium salt
ECHA has flagged the group of orthoboric acid and sodium salt to be a concerning toxicant for reproduction. Moreover, there is strong evidence of it being a human endocrine disruptor, shares the Environmental Working Group’s Skin Deep. 

“Sodium Borate and Boric Acid are colorless or white crystals or powders. In cosmetics and personal care products, Sodium Borate and Boric Acid are used to formulate a wide variety of product types, including creams and lotions and bath, hair and skin products,” shares Cosmetics Info. 

L’Oréal shares that boric acid can have skin benefits and is used as an astringent and product stabilizer in cosmetics. “In skincare, boric acid’s stabilizing properties are frequently paired with glycerin’s moisturizing capabilities to ensure longer lasting product quality. For these reasons, boric acid can most commonly be found in lotions and creams.”

What’s next
ECHA explains it has a legal obligation to regularly recommend substances from the Candidate List for the Commission to include in the Authorisation List.

During a three-month consultation, comments are received and opinions from Member State Committees are considered before submitting its recommendation to the European Commission (EC).

After this, the EC can decide which substances should be included in the Authorisation List and what conditions apply to each. 

The Authorization List aims at promoting the substitution of substances of very high concern when “technically and economically viable alternatives are available. Until this is achieved, the goal is to ensure proper control of risks for human health and the environment.”

By Venya Patel