Post-Brexit mandatory classifications that diverge from EU CLP generally less strict, analysis finds

Chemical Watch News

Chemical Watch News & Insight review shows decisions are not wholly aligned for 15 of initial 98 substances

Substance & mixture classification
Hazard assessment
EU CLP
National - UK

Brexit - divergence concept © mvdesign - stock.adobe.com

Britain’s initial set of mandatory classifications tend to be less strict where they diverge from categorisations under the EU CLP, an analysis by Chemical Watch News & Insight has shown.

The finding raises the possibility that companies operating in Britain (England, Scotland and Wales) could gain a competitive advantage over EU competitors because of less stringent regulation under the GB CLP, with potential for negative impacts on human health and the environment. However, companies operating in both jurisdictions may find themselves hampered by additional complexity and administrative burdens as they may need to, for example, label products differently.

Britain set mandatory classifications under post-Brexit chemicals legislation for the first time on 20 October. The classifications, covering 98 substances, stem from opinions of ECHA’s Risk Assessment Committee (RAC) published in 2019 and 2020. The EU already set classifications for the same substances in 2021 and 2022 through the adaptation to technical progress (ATP) process.

For 15 of the 98 substances affected, the classifications are not wholly aligned. And a Chemical Watch News & Insight analysis shows that the EU classification is stricter than the British equivalent for 12 of those 15 diverging substances (see table), or 80% of the time.

HSE rejected some RAC conclusions

The extent of the divergence varies considerably from substance to substance.

At one extreme, the EU classification follows the RAC recommendation, while Britain has no classification for the same endpoint. For example, the biocide azamethiphos has a category 2 carcinogenicity classification in the EU, but no classification for carcinogenicity in Britain.

In a technical report on RAC’s azamethiphos opinion published in 2021, Britain’s national regulator for chemicals the Health and Safety Executive (HSE) concluded that classification was unwarranted because tumours seen in relevant studies "could be regarded as incidental findings". There was no clear dose-response relationship and no statistical significance, the agency added.

The HSE did agree with RAC on classifications for azamethiphos for six other endpoints, however. 

For other substances, the divergence is minimal. For the pesticide trifloxystrobin, for example, the EU and Britain both have a category 2 specific target organ toxicity with repeat exposure classification (STOT RE 2). However, in the EU the classification is for effects in the kidney as well as in the blood, whereas in Britain it is only for effects in the blood.

In all 15 cases of divergence, the deviation from the relevant RAC opinion originates in the HSE technical reports, published in 2021. The HSE agreed with its own technical report recommendations in all of its subsequent opinions, published in 2022. The ministerial decisions likewise have not deviated from those 2021 recommendations.

There are "limited" instances of difference between the British classifications, the RAC opinions, and the equivalent EU classifications, an HSE spokesperson said. "While the UK recognises the importance of the EU single market, as a third country, the UK must now make its own decisions regarding the classification and labelling of hazardous chemicals," they added.

They also said that where HSE proposes a less severe classification than RAC, "this does not necessarily mean that the overall classification proposed is less protective for human health and the environment".

Divergence remains a concern

Regulatory divergence from the EU as a result of Brexit remains a hot topic in UK political circles.

The Labour Party, which is projected to win the next general election that must be held by January 2025, said in October that it will aim to minimise divergence on REACH to increase protections from hazardous chemicals that are "falling behind due to a real lack of data and resources in the UK system".

Further mandatory classifications are in the pipeline, with ministers expected to take decisions for another 26 substances in the first quarter of next year.

Substance

CAS No

EC No

Regime

More Strict

Divergence

(R)-p-mentha-1,8-diene;
d-limonene

5989-27-5

227-813-5

REACH, PPPR

UK

EU has Aquatic Chronic 3, H412. UK has Aquatic Chronic 1, H410 with an M-factor of 1

4,4'-isopropylidenediphenol (Bisphenol A; BPA)

80-05-7

201-245-8

REACH

EU

EU has Aquatic Chronic 1, H410 with an M-factor of 10. UK has Aquatic Chronic 2, H411

Ammonium bromide

12124-97-9

235-183-8

REACH, BPR

EU

EU has Repr. 1B, H360FD (May damage fertility. May damage the unborn child). UK has Repr. 1B, H360Fd (May damage fertility. Suspected of damaging the unborn child)

Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate

35575-96-3

252-626-0

BPR

EU

EU has Carc. 2, H351 (Suspected of causing cancer). UK has no classification for same endpoint

Barium diboron tetraoxide

13701-59-2

237-222-4

REACH

EU

EU has Acute Tox. 4, H332 (Harmful if inhaled) with an ATE value of 1.5 mg/L. UK has no classification for same endpoint

Beta-cyfluthrin (ISO); reaction mass of rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3S)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate and rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate (ratio 1:2)

1820573-27-0

-

PPPR

EU

EU has STOT SE 1, H370 (May cause damage to the
nervous system). UK has no classification for same endpoint

Cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

68359-37-5

269-855-7

BRP

EU

EU has STOT SE 1, H370 (May cause damage to the
nervous system). UK has no classification for same endpoint

Esfenvalerate (ISO);
(S)-α-cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate

66230-04-4

 -

PPPR, BPR

N/A

EU has STOT SE 1, H370 (Causes
damage to the nervous system). UK has no classification for same endpoint. But EU has Acute Tox. 3, whereas UK has Acute Tox. 2.

Mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric ) complex with zinc salt

8018-01-7

 -

PPPR

EU

EU has Repr. 1B, H360D. UK has Repr. 2, H361d

Mecoprop-P (ISO) [1] and its salts;
(R)-2-(4-chloro-2-methylphenoxy)propionic acid [1] and its salts

16484-77-8 [1]

240-539-0 [1]

PPPR

EU

EU has M-factor of 10 for Aquatic Chronic 1. UK has M-factor of 1 for same endpoint

Methyl salicylate

119-36-8

204-317-7

REACH

EU

EU has Aquatic Acute 3., H412 (Harmful to aquatic life with
long-lasting effects). UK has no classification for same endpoint

Guinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone

2797-51-5

220-529-2

PPPR

EU

EU has STOT RE 2 for effects in the kidney, as well as in the blood. UK has STOT RE 2 only for effects in the blood

RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate;
tolpyralate

1101132-67-5

 -

PPPR

EU

EU has Repr. 2, H361fd. UK has Repr. 2, H361d.

Trifloxystrobin (ISO); methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxy]-o-tolyl}acetate

141517-21-7

 -

PPPR

UK

EU has M-factor of 10 for Aquatic Chronic 1. UK has M-factor of 100 for same endpoint

Trinexapac-ethyl (ISO);
ethyl 4-[cyclopropyl(hydroxy)methylene]-3,5-dioxocyclohexanecarboxylate

95266-40-3

 -

PPPR

EU

EU has STOT RE 2, H373 (May cause damage to the GI tract
through prolonged or repeated exposure). UK has no classification for same endpoint

This article was updated on 9 November to include comments from the HSE.