CLP/REACH News for January 2022

Reminder of the regulatory changes in January 2022 

In a press release dated January 18, 2022, the European Chemicals Agency (ECHA) recalled the entry into force in January 2022 of the amended annexes of REACH. This amendment clarifies the obligation for companies to choose the right dose of substance for their toxicity tests in order to conclude on the safety of their chemicals. The release states that ECHA’s guidance document on “Information Requirements and Chemical Safety Assessment – Chapter R.7a” will be revised to take into account the amended REACH annexes. It will be published later in 2022.

Public consultations  

Calls for information and valid scientific advice  A public consultation is open until 11 March 2022 through which ECHA is currently inviting third parties to submit scientifically valid information and studies on the hazard endpoints for 4 substances:

• N-butyl pyrrolidone (EC No: 222-437-8; CAS No: 3470-98-2): reproductive toxicity (extended one-generation reproductive toxicity study);
• 5-Amino-2-nitrobenzoic acid (EC No.: 236-283-4; CAS No.: 13280-60-9): in vivo genetic toxicity;
• Reaction products of [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and triacetoxyvinylsilane (EC No.: 237-272-7; CAS No.: 13718-26-8);
• Sodium metavanadate (EC No.: 237-272-7 ; CAS No.: 13718-26-8): reproductive toxicity – one generation extended reproductive toxicity study & prenatal developmental toxicity).

Harmonized classification and labeling  A public consultation is open until March 18, 2022 on the harmonized classification and labeling for the following product: n-hexane (EC No. 203-777-6; CAS No. 110-54-3).

Press releases 

In a press release dated January 17, 2022, ECHA announced the addition of the following 4 substances to the list of candidate substances of very high concern:

• 2,2′-methylenebis (4-methyl-6-tert-butylphenol) or MBMBP (EC No. 204-327-1; CAS No. 119-47-1);
• tris(2-methoxyethoxy)vinylsilane (EC No: 213-934-0; CAS No: 1067-53-4);
• ((±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of these individual isomers and/or combinations thereof) (EC No.: -; CAS No.: -) ;
• S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (EC No: 401-850-9; CAS No: 255881-94-8).

The third substance is used in cosmetics and was added to the list because it has hormone-disrupting properties in humans. The first two are used, for example, in rubbers, lubricants and sealants, and were included for their negative effect on fertility. The fourth is used in lubricants and greases and was added because it is persistent, bioaccumulative and toxic, and therefore harmful to the environment. In a separate release, ECHA announced the update of the tool (IUCLID) that contains all the data of the chemicals to follow the addition of these 4 SVHC. As a reminder, all producers, importers, distributors and assemblers of articles or complex articles containing a substance of very high concern above 0.1% w/w in an article must submit a SCIP notification under Article 33 of the REACH Regulation. In addition, ECHA has reminded companies still wishing to claim the registration numbers assigned to their NONS notifications – for substances previously notified under the so-called Dangerous Substances Directive 67/548/EEC – that they can do so until 17 July 2022. The press release of 17 January clarifies that after this date, ECHA will end the possibility to request registration numbers for new substances. As a reminder, the notification process refers to the submission of a dossier containing relevant information about a new substance, i.e. a substance placed on the market in the EU after 18 September 1981, to the Competent Authority of a Member State. The obligation to notify “new substances” under the Dangerous Substances Directive was replaced by the obligation to register under the REACH Regulation after its entry into force. Substances previously notified under the Dangerous Substances Directive are commonly referred to as “NOs” under REACH. Thus, companies are still given time to make the transition between the two regulations.