REACH

Amendment of the REACH Regulation

By Regulation (EU) 2022/586 of 8 April 2022, the Commission has amended Annex XIV of Regulation (EC) No 1907/2006 of 18 December 2006, known as the REACH Regulation, listing the substances subject to authorization. Thus the following 5 entries have been added to the table:

• Tetraethyl lead (EC No.: 201-075-4; CAS No.: 78-00-2) ;
• 4,4′-bis(dimethylamino)-4″-(methylamino)trityl alcohol [with ≥ 0.1% Michler’s ketone (EC No.: 202-027-5) or Michler’s base (EC No.: 202-959-2)] (EC No.: 209-218-2; CAS No.: 561-41-1) ;
• Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (PR-HP) (with ≥ 0.1% w/w 4-heptylphenol, branched and linear) ;
• 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC No.: 239-622-4; CAS No.: 15571-58-1)
• Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE and MOTE reaction mass).

Companies wishing to continue using or placing these substances on the market have until November 1, 2023 to apply. Also, the placing on the market and use of these substances will be prohibited as of May 1, 2025, unless an authorization is granted.

Decisions of the Commission           

Concerning the substance 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (4- tert -OPnEO) In April 2022, several Commission Decisions authorized the substance 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (4- tert -OPnEO) to be placed on the market:

• Decision C(2022) 1518 of 17 March 2022: this substance may be used industrially until January 4, 2028 for its detergent properties in the cell lysis process for the production of in vitro diagnostic reagents. This substance can also be used industrially to limit the amount of non-specific reactions in the production of in vitro diagnostic reagents.
• Decision C(2022) 2163 of April 8, 2022: this substance can be used industrially until January 4, 2025 for its non-ionic detergent properties consisting in the filling of solutions containing 4-tert-OPnEO, in specific single-use ampoules, to be included in in vitro clinical and industrial trial applications.
• Decision C(2022) 2174 of April 8, 2022: this substance can be used industrially until January 4, 2025 for its non-ionic detergent properties consisting in the filling of solutions containing 4-tert-OPnEO, in specific single-use ampoules, to be included in in vitro clinical and industrial trial applications.
• Decision C(2022) 2178 of April 11, 2022: this substance may be used industrially until January 4, 2033 for its amphiphilic, surface-active, and non-hemolytic properties to create controlled hydrophilic stains on porous hydrophobic membranes (in solid form) for in vitro diagnostic kits for blood testing by antigen or antibody reaction in the following product line: control cards, manual pads, and automated ONYX
• Decision C(2022) 2191 of April 11, 2022: this decision authorizes the use of this substance until January 4, 2033 as a surfactant in the manufacture of a biopharmaceutical protein – a biosimilar product – used to prevent infection and febrile neutropenia.

 

Concerning the substance 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO)

In April 2022, by Decision C(2022) 1789 of 17 March 2022, the Commission granted authorization for the substance 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO) for industrial use of emulsifiers containing 4-NPnEO for the manufacture of chromatographic resins used by the biopharmaceutical industry, the food, and beverage sector and academia. This authorization is issued to one company until January 4, 2033.

Testing proposals

A public consultation, open until May 16, 2022, invites third parties to submit scientifically valid information and studies on 21 substances.

Occupational exposure limit 

A public consultation is open until June 10, 2022 on the occupational exposure limit for cobalt and its inorganic compounds in view of the preparation of a scientific report by the Risk Assessment Committee (RAC). Communications 

Upcoming changes in the information required for registration

In a press release dated April 12, 2022, the European Chemicals Agency (ECHA) explained the main changes induced by the update of the annexes of the REACH Regulation that will apply from October 14, 2022. Thus, companies should be familiar with the following changes:

• Specific requirements and rules for the adaptation of the different toxicity, mutagenicity, degradation, and bioaccumulation studies ;
• The requirement for sole representatives to provide details of the non-EU manufacturer they represent ;
• Substance identification information, including the obligation to describe compositions to meet the information requirements of Annex VII-X of REACH.

ECHA also informs that it is working on updating its guidance documents and will publish guidance on information requirements for registrants in the second half of 2022.

The Restrictions Roadmap under the Chemicals Strategy for Sustainable Development

The Commission published its roadmap on restrictions under the Chemicals Strategy for Sustainable Development on 25 April 2022. As a reminder, this strategy stemming from the Green Deal is about avoiding the use of the most harmful chemicals for non-essential purposes for society and using all industrial chemicals in a safer and sustainable way. The roadmap is structured around 4 axes:

• The context for producing this document;
• The objectives of this roadmap;
• The process for identifying (groups of) substances for the permanent list of the Restriction Roadmap;
• The permanent list of (groups of) substances to be restricted.

Identification of the need for restrictions on bisphenols

In an April 6, 2022, statement, ECHA, and member states evaluated a group of 148 bisphenols and recommended that more than 30 of them be restricted due to their potential hormonal or reprotoxic effects. Of these bisphenols, 3 were identified as substances of very high concern (SVHC):

• bisphenol A (CAS No.: 80-05-7) ;
• bisphenol B (CAS No.: 77-40-7);
• 2,2-bis(4′-hydroxyphenyl)-4-methylpentan (CAS No.: 6807-17-6).

CLP

A first public consultation on the harmonized classification and labeling of the following substances was opened on April 11, 2022. It closes on 10 June 2022:

• pethoxamid (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide (CAS No.: 106700-29-2) ;
• propyl 4-hydroxybenzoate (EC No.: 202-307-7: CAS No.: 94-13-3)
• α,α’-propylenedinitrilodi-o-cresol (EC No.: 202-374-2; CAS No.: 94-91-7)

Another public consultation on the harmonized classification and labeling of the following three substances opened on April 25, 2022 and closes on June 24, 2022:

• Chrysanthemum cinerariaefolium, extract of open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide (EC No.: 289-699-3; CAS No.: 89997-63-7);
• Chrysanthemum cinerariaefolium, extract of open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents (EC No.: 289-699-3; CAS No.: 89997-63-7);
• 2-phenylpropene (EC No.: 202-705-0; CAS No.: 98-83-9).