A new year has just begun, and the one we have just left behind has been eventful for those working in the chemical regulatory field; therefore, it is only fitting that we summarize the past 12 months.
Let’s take a look together at what were the most important updates of 2023, a year that was full of news and in some cases a watershed between old and new legislation.
We will proceed by dividing the updates into two major thematic groups: REACH and CLP.
REACH
Microplastics
The restriction on synthetic polymer microparticles, so called microplastics (entry n. 78 of Annex XVII, REACH Regulation), entered into force on the 17th October 2023.
The restriction arises from the European Commission’s intention to reduce “microplastic pollution”, caused by the presence of tiny fragments of synthetic or chemically modified natural polymers, which are insoluble in water, degrade very slowly and are widespread in the environment.
Formaldehyde
The European Commission restricted formaldehyde and formaldehyde-releasing substances (entry n. 77 of Annex XVII, REACH Regulation).
PFAS
ECHA received 5 642 contributions from the public consultation regarding the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the EEA.
Bis(2-ethylhexyl) phthalate (DEHP)
The European Commission has extended the deadline for applications to use DEHP in medical devices to 1 January 2029. The sunset date has been extended to 1 July 2030.
1,4-dioxane
The submission of the Restriction report on 1,4-dioxane was postponed to October 2025.
Bisphenols
German CA have momentarily withdrawn their restriction proposal on bisphenols that have ED properties to the environment and their salts. The restriction proposal will be updated and re-submitted.
Lead in PVC
The European Commission introduced a restriction (entry 63, Annex XVII, REACH) to the use and placing on the market of lead in polyvinyl chloride (PVC) articles.
Candidate List
ECHA has updated the Candidate List adding 9 hazardous chemicals in January () and 2 hazardous chemicals in June (Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, Bis(4-chlorophenyl) sulphone).
Authorisation List
ECHA has recommended adding 8 substances (ethylenediamine; 2-(4-tertbutylbenzyl)propionaldehyde and its stereoisomers; lead; glutaral; 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone; diisohexyl phthalate and orthoboric acid, sodium salt) to the Authorisation List. Once substances are added to the list, companies will need to apply for authorisation to continue using them.
CLP
Regolamento delegato (UE) 2023/707
On 03/31/2023, the European Commission published in the Official Journal Delegated Regulation (EU) 2023/707, which amends the CLP Regulation by establishing new hazard classes and new criteria for the classification, labelling, and packaging of substances and mixtures.
This legislation is binding on manufacturers, importers, downstream users and distributors placing substances on the EU market and applies from April 20, 2023. There are transition periods from the entry into force of the delegated regulation:
– For new substances on the market, companies will have to comply with the new rules from May 1, 2025, while for substances already on the EU market, they will have until November 1, 2026.
– For mixtures, separate transition periods apply. The new hazard classes will apply from May 1, 2026, to new mixtures, while companies will have until May 1, 2028, to update the classification and labelling of existing mixtures.
- Delegated Regulations (UE) 2023/1434 e and 2023/143
On July 11, 2023, the European Union published Delegated Regulations (EU) 2023/1434 and 2023/143, known as ATP 19 and ATP 20 respectively (ATP = adaptation to technical and scientific progress) of CLP, which make interrelated changes:
Commission Delegated Regulation (EU) 2023/1434 amends Annex VI, Part 1 of Regulation (EC) No. 1272/2008 by adding the following notes: Note X (to Section 1.1.3.1), Note 11 and Note 12 (to Section 1.1.3.2), to clarify that:
– the classification of a group of substances under the same heading is based solely on the hazardous properties of that part of the substance common to all substances under that heading;
– in classifying mixtures containing boric acid and its salts and other boric acid/borate releasing compounds as toxic to reproduction, the principle of additivity applies: “Classification of mixtures as toxic to reproduction is required if the sum of the concentrations of the individual boron compounds classified as toxic to reproduction in the mixture placed on the market is ≥ 0.3 %.”
– in classifying mixtures containing certain substances listed in a group entry (such as, for example, 2-ethylhexanoic acid and its salts) as toxic to reproduction, the principle of additivity applies: “Classification of mixtures as substances toxic to reproduction is required if the sum of the concentrations of the individual substances listed in this entry in the mixture placed on the market is equal to or greater than the applicable generic concentration limit for the assigned category or a specific concentration limit specified in this entry.”
Commission Delegated Regulation (EU) 2023/1435 amends Annex VI, Part 3 of Regulation (EC) No. 1272/2008 by updating the harmonized classification and labelling for the following entries:
– Index No. 005-007-00-2 relating to boric acid
– Index No. 005-008-00-8 relating to diboron trioxide
– No. Index 005-011-00-4 relating to tetraboron disodium heptaoxide, hydrate; disodium tetraborate, anhydrous; orthoboric acid, sodium salt; disodium tetraborate decahydrate; disodium tetraborate pentahydrate
– Index No. 607-230-00-6 relating to 2-ethylhexanoic acid and its salts.
Both regulations took effect on July 31, 2023. To give suppliers an adjustment period, Reg. (EU) 2023/1435 will be mandatorily applicable as of February 1, 2025.
- PCN Notification:
As a reminder, by the CLP Regulation, importers and downstream users who have submitted information on hazardous mixtures to a body designated under Article 45(1) (e.g., Istituto Superiore di Sanità for Italy), before the expiration dates of:
– January 1, 2021, for products intended for consumption;
– January 1, 2021, for products intended for professional use;
– January 1, 2024, for products intended for industrial use.
are required to comply with the provisions of Annex VIII of the CLP reg. for such mixtures as of January 1, 2025.
In simpler words, the transitional period under Annex VIII has ended for all products that were placed on the market and notified before the above deadlines (notified under the old non-harmonized format). As of January 1, 2025, all products subject to notification are required to be notified according to the new harmonized format (PCN notification) by Annex VIII of the CLP reg.
- In addition:
In the CLP regulatory sphere, activity has already begun in the new year as well. Opening the dance is the publication on January 5th of this year of the 21st ATP of the CLP reg. (i.e., Reg. (EU) 2024/197), which will enter into force on January 25th, 2024, and will apply mandatorily as of September 1, 2025. This regulation amends Annex VI of the CLP reg. by introducing or updating the harmonized classification and labelling of several substances, including lead, for which the current aquatic toxicity classification for lead dust has been modified with the M-factor and a different aquatic toxicity classification has been introduced for massive lead.
