Last reviewed 25 August 2023

In this feature, Caroline Raine outlines the changes expected to the Regulation on the classification, labelling and packaging of substances and mixtures (CLP) through the 22nd Adaptation to Technical Progress (ATPs), note that it is currently being discussed and is not yet even in a draft stage.

Background

The 22nd Adaptation to Technical Progress (ATP) to the Regulation on the classification, labelling and packaging of substances and mixtures (CLP) is not yet published in draft form, but instead is being discussed at the European Chemicals Agency (ECHA) in the Competent Authorities for REACH and CLP (CARACAL) meetings.

22nd ATP

The 22nd ATP is currently being discussed and the following substances are expected to be included.

Substance

Existing classification

Proposed new classification

1,4-Dichloro-2-nitrobenzene (EC 201-923-3, CAS 89-61-2)

The substance has no current Annex VI entry.

RAC agreed to the proposal by the Netherlands to classify 1,4-dichloro-2-nitrobenzene as a substance that may cause cancer (Carc. 1B; H350).

Dibenzoyl peroxide; benzoyl peroxide (EC 202-327-6, CAS 94-36-0)

It has a current entry in Annex VI to the CLP Regulation as a substance which may cause a fire or explosion upon heating (Org. Perox. B; H241), causes serious eye irritation (Eye Irrit. 2; H319) and which may cause an allergic skin reaction (Skin Sens. 1; H317).

RAC agreed to the proposal by Ireland to classify dibenzoyl peroxide as very toxic to aquatic life (Aquatic Acute 1; H400, with M-factor of 10)) and very toxic to aquatic life with long last- ing effects (Aquatic Chronic 1; H410, with M-factor of 10).

n-Hexane (EC 203-777-6, CAS 110-54-3)

The substance has a current entry in Annex VI to the CLP Regulation as a highly flammable liquid (Flam. Liq. 2; H225), a substance that may be fatal if swallowed and enters air- ways (Asp. Tox. 1; H304), causes skin irritation (Skin Irrit. 2; H315), may cause drowsiness or dizziness (STOT SE 3; H336), is suspected of damaging fertility (Repr. 2; H361f***), may cause damage to organs (STOT RE 2*; H373**) and is toxic to aquatic life with long lasting effects (Aquatic Chronic 2; H411). The substance also has a specific concentration limit (SCL) of C 5% associated with the STOT RE 2; H373 classification.

RAC agreed to the proposal by Germany to modify the STOT RE classification to a substance which causes damage to the nervous system (STOT RE 1; H372 (nervous system)) and to re- move the SCL from the STOT RE classification.

Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol (glycerol formal)

(EC -, CAS -)

The substance has no current Annex VI entry.

RAC agreed to the proposal by the Netherlands to classify glycerol formal as a substance that may damage the unborn child and is suspected of damaging fertility (Repr. 1B; H360Df).

Copper (EC 231-159-6, CAS 7440-50-8)

Copper does not have an existing classification but copper flakes are classified as harmful if swallowed (Acute Tox. 4; H302), cause serious eye irritation (Eye Irrit. 2; H319), toxic if inhaled (Acute Tox. 3; H331), very toxic to aquatic life (Aquatic Acute 1; H400 (M=10) and very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410). Granulated copper also has an existing Annex VI entry as toxic to aquatic life with long lasting effects (Aquatic Chronic 2; H411).

RAC agreed to the proposal by Sweden to use the specific surface area of 0.67 mm2/mg (equivalent to the surface area of copper spheres with a diameter of 1 mm) to distinguish be- tween massive and powder copper. RAC also agreed to the proposal to classify copper with a specific surface area > 0.67 mm2/mg (powder) as very toxic to aquatic life (Aquatic Acute 1; H400 (M=10)) and very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410 (M=1)). Copper with specific surface area 0.67 mm2/mg (massive) will have no classification.

tert-Butyl 2-ethylperoxyhexanoate (EC 221-110-7; CAS 3006-82-4)

The substance has no current Annex VI entry.

RAC agreed to the proposal by France to classify tert-butyl 2-ethylperoxyhexanoate as a sub- stance which may damage fertility or the unborn child (Repr. 1B; H360FD) and may cause an allergic skin reaction (Skin Sens. 1; H317 instead of the proposed classification as Skin Sens. 11B).

Pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxyme- thyl}phenyl) N-methoxy carbamate (EC - ; CAS 175013-18-0)

The substance has a current Annex VI entry as toxic if inhaled (Acute Tox. 3*; H331), causes skin irritation (Skin Irrit. 2; H315), very toxic to aquatic life (Aquatic Acute 1; H400 (M=100)) and very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410).

RAC agreed to the proposal by Germany that pyraclostrobin (ISO) is suspected of damaging the unborn child (Repr. 2; H361d), is toxic if inhaled (Acute Tox. 3; H331, with an ATE of 0.58 mg/L for dusts or mists), is harmful if swallowed (Acute Tox, 4; H302, with an ATE of 450 mg/kg bw), causes skin irritation (Skin Irrit. 2; H315), may cause respiratory irritation (STOT SE 3; H335), may cause damage to liver and gastrointestinal tract, and also agreed to add nasal cavity as a target organ (STOT RE 2; H373), is very toxic to aquatic life (Aquatic Acute 1; H400 (M=100)) and very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410 (M=100)).

Biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl (EC 201-993-5, CAS 90-43-7)

It has a current entry in Annex VI to the CLP Regulation as a substance which causes skin irritation (Skin Irrit. 2; H315), causes serious eye irritation (Eye Irrit. 2; H318), may cause respiratory irritation (STOT SE 3; H335) and is very toxic to aquatic life (Aquatic Acute 1; H400).

RAC agreed to the proposal by Spain to add the classification as a substance which is suspected of causing cancer (Carc. 2; H351), to modify the existing classifications to indicate that it causes skin corrosion (Skin Corr. 1; H314) and serious eye damage (Eye Dam. 1; H319), to retain the classification as very toxic to aquatic life (Aquatic Acute 1; H400 (but to add the M- factor M=1)) and to add that the substance is very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410 (M=1)). The Committee agreed to remove the existing STOT SE 3 classification and to classify biphenyl-2-ol as a skin sensitiser (Skin Sens. 1B; H317).

Fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine (EC -, CAS 67306-00-7)

The substance has no current Annex VI entry.

RAC agreed to the proposal by the Czech Republic (Co-Rapporteur Member State Germany) to classify fenpropidin as a substance which is harmful if swallowed (Acute Tox. 4; H302 (ATE=1330 mg/kg bw)), is harmful if inhaled (Acute Tox. 4; H332), causes skin irritation (Skin Irrit. 2; H315 — contrary to the proposal by the Dossier Submitter, who proposed no classification for this hazard class), causes serious eye damage (Eye Dam. 1; H318), may cause an al- lergic skin reaction (Skin Sens. 1; H317 — contrary to the proposal by the Dossier Submitter, who proposed sub-category 1B for this hazard class), may cause respiratory irritation (STOT SE 3; H335), may cause drowsiness or dizziness (STOT SE 3; H336 — contrary to the proposal by the Dossier Submitter, who proposed no classification for narcotic effects), may cause dam- age to the nervous system, eye and lung (STOT RE 2; H373), is suspected of damaging the unborn child (Repr. 2; H361d), is very toxic to aquatic life (Aquatic Acute 1; H400 (M=1000) and is very toxic to aquatic life with long lasting effects (Aquatic Chronic 1; H410 (M=10000)).

Cyclohex-3-ene-1-carbaldehyde derivatives

These substances have no current Annex VI entry.

RAC agreed to the proposal by Germany to classify these as substances which may cause an allergic skin reaction (Skin Sens. 1; H317 instead of the proposed classification as Skin Sens. 1A).

Note that the 22nd ATP, once published will only apply in the EU and the UK has not yet adopted the changes in the 18th ATP or draft 19th, 20th ATP, 21st ATP to GB CLP. Some of the substances have been notified to the World Trade Organization (WTO) and an update to the GB CLP mandatory list of classifications is expected later in 2023.

Conclusions

Check your substances lists carefully and ensure that all hazard communication (labels, safety data sheets etc) are updated in a timely manner.