Urgent information update about biocidal active substances from April 2023.
HSENI has been made aware that information relating to dates for the withdrawal of active substance approval for two active substances has been published incorrectly in ebulletins produced by HSE(GB) in April 2023 and subsequently posted on the HSENI website.
Furthermore, eight active substance/product type combinations with associated phase-out dates were not published by HSE at this time. All corrections and missing information can be found at the following link:
For specfic news in relation to Biocides please click on the link below:
Commission adopts EU-wide formaldehyde restriction
On 14 July 2023, the European Commission adopted measures to better protect people from cancer risks by introducing a maximum emission limit for the carcinogenic substance formaldehyde in a range of consumer products.
The restriction proposal was prepared by the European Chemicals Agency (ECHA) in March 2019. The scientific committees for Risk Assessment and for Socio-Economic Analysis supported the proposal in their opinions of 2020.
For more information please see:
New intention to identify a substance of very high concern
One intention has been received by ECHA for:
- Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol (EC 700-960-7, CAS -)
New substance evaluation conclusions published for CoRAP substances
- Tin sulphate (EC 231-302-2, CAS 7488-55-3) was added to the Community rolling action plan (CoRAP) list in 2016 and evaluated by France
- Sodium chlorite (EC 231-836-6, CAS 7758-19-2) was added to the CoRAP list in 2019 and evaluated by Hungary
- Propyl 4-hydroxybenzoate (EC 202-307-7, CAS 94-13-3) was added to the CoRAP list in 2015 and evaluated by Belgium
- Amphoteric Fluorinated Surfactant (EC confidential, CAS confidential) was added to the CoRAP list in 2018 and evaluated by Belgium
- A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan] (EC 422-040-1, CAS 426218-78-2) was added to the CoRAP list in 2016 and evaluated by Spain
Consultations for applications for authorisation and review reports
ECHA have launched a consultation on 12 applications for authorisation and 11 review reports covering a total of 43 uses of:
- Chromium trioxide (EC 215-607-8), Sodium dichromate (EC 234-190-3), Potassium dichromate (EC 231-906-6), Sodium chromate (231-889-5), Dichromium tris(chromate) (EC 246-356-2) for various uses in the aerospace and defence industry and their supply chains
40 of these consultations cover uses of soluble chromates applied for by the member of the Aerospace and Defence Chromates Reauthorisation (ADCR) Consortium.
More information about the uses applied for, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on our website.
Have your say by using the webform (ECHA website) by 11 October 2023.
Assessment of regulatory needs reports published
Reports for the following substance groups are now available on the ECHA website:
- Photoinitiators (benzoyl radical precursor type)
- Organic hydroperoxides and aliphatic/cumyl peroxides
- Ethoxylated alcohol phosphates and phosphinic acid derivatives
If you have questions or feedback related to the assessment work, you can send them to us using this webform (ECHA website)
Consultations on harmonised classification and labelling
ECHA are looking for comments on several harmonised classification and labelling (CLH) proposals. Note the deadlines for different consultations:
- Burgeonal group:
- 2-(4-tert-butylbenzyl) propionaldehyde (EC 201-289-8, CAS 80-54-6)
- 4-tert-butylbenzoic acid (EC 202-696-3, CAS 98-73-7)
- 3-(4-tert-butylphenyl)propionaldehyde [1]; 4-tert-butyltoluene [2]; 4-tert-butylbenzaldehyde [3]; methyl 4-tert-butylbenzoate [4] (EC 242-016-2 [1]; 202-675-9 [2]; 213-367-9 [3]; 247-768-5 [4], CAS 18127-01-0 [1]; 98-51-1 [2]; 939-97-9 [3]; 26537-19-9 [4])
- Cyclamal group
- p-cymene; 1-isopropyl-4-methylbenzene (EC 202-796-7, CAS 99-87-6) and
- 3-p-cumenyl-2-methylpropionaldehyde; 2-methyl-3-(4-isopropylphenyl)propanal [1]; 3-(p-cumenyl)propionaldehyde; 3-(4-isopropylphenyl)propanal [2]; 4-isopropylbenzaldehyde; cuminic aldehyde [3]; 4-isopropylbenzoic acid; cuminic acid [4] (EC 203-161-7 [1]; 231-885-3 [2]; 204-516-9 [3]; 208-642-5 [4], CAS 103-95-7 [1]; 7775-00-0 [2]; 122-03-2 [3]; 536-66-3 [4])
Have your say by 22 September 2023.
- bronopol; 2-bromo-2-nitropropane-1,3-diol (EC 200-143-0, CAS 52-51-7)
- 4,4'-methylenediphenol; bisphenol F (EC 210-658-2, CAS 620-92-8)
Have your say by 29 September 2023.
- 3,5-dimethylpyrazole (EC 200-657-5, CAS 67-51-6)
- 3,4-dimethyl-1H-pyrazole (EC 429-130-1, CAS 2820-37-3)
- 3,4-dimethyl-1H-pyrazol-1-ium dihydrogen phosphate (EC 424-640-9, CAS 202842-98-6)
- borate minerals:
- ulexite (CaNaH12(BO3)5.2H2O) [1]; ulexite (CaNaH12(BO3)5.2H2O), calcined [2] (EC - [1] 296-662-5 [2], CAS 1319-33-1 [1] 92908-33-3 [2])
- colemanite (CaH(BO2)3.2H2O) [1]; boron calcium oxide (B6Ca2O11), hydrate (1:5) [2]; colemanite, calcined [3] (EC - [1] - [2] 296-640-5 [3], CAS 1318-33-8 [1] 854267-07-5 [2] 92908-12-8 [3])
- tincalconite (B4Na2O7.5H2O) (EC -, CAS 12045-88-4)
- rape oil; rape seed oil (EC 232-299-0, CAS 8002-13-9)
For rape oil; rape seed oil, the proposal format combines the draft (renewal) assessment report prepared according to the Plant Protection Products Regulation and the proposal for CLH under the CLP regulation. For additional information, please see the following link:
European Food Safety Authority has already granted approval for rape seed oil. For more information on this active substance and on the studies included in the CLH report, consult the draft assessment report on the European Food Safety Authority's website:
Have your say by 13 October 2023.
Call for evidence: screening report on trixylyl phosphate
The European Chemicals Agency (ECHA) are looking for relevant information and comments on a draft screening report on:
- trixylyl phosphate (EC 246-677-8) in products (articles)
As required by REACH Article 69(2), ECHA are investigating whether the use of these substances in articles is adequately controlled, and if a restriction is needed.
For more information and to comment, please see the link below:
Have your say by 9 August 2023.
ECHA adds two hazardous chemicals to Candidate List
The Candidate List of substances of very high concern now contains 235 entries for chemicals that can harm people or the environment. Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use.
SEAC draft opinion consultation on medium-chain chlorinated paraffins (MCCP)
ECHA are looking for comments on the draft opinion of the Committee for Socio-economic Analysis (SEAC) concerning the restriction proposal from ECHA on:
Have your say by 14 August 2023.
Call for evidence: screening report on sixteen 1, 3 dioxanes
ECHA are looking for comments on a draft screening report, and for relevant information on sixteen 1,3-dioxanes (also known as ‘Karanal’) in products (articles).
As required by REACH Article 69(2), ECHA are investigating whether the use of these substances in articles is adequately controlled, and if a restriction is needed.
Have your say by 31 July 2023.
Compliance date for industrial use only mixtures approaching
From 1 January 2024 all new poison centre notifications must comply with the harmonised information requirements. These include the full chemical composition, the toxicological information, information about the product and the unique formula identifier (UFI) according to Annex VIII to the CLP Regulation. The 1 January 2024 compliance date brings onboard also the mixtures for industrial use only.
Consultation on harmonised classification and labelling
ECHA are looking for comments on the harmonised classification and labelling proposals for:
- trihydrogen pentapotassium di(peroxomonosulfate) di(sulfate) (EC 274-778-7, CAS 70693-62-8)
- piperonal; 1,3-benzodioxole-5-carbaldehyde (EC 204-409-7, CAS 120-57-0)
Have your say by 11 August 2023.
For further information please see the link below:
Call for evidence: screening report on UV-328, UV-327, UV-350 and UV-320
ECHA are looking for relevant information and comments on a draft screening report on:
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328);
- 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327);
- 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350); and
- 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) in products (articles).
As required by REACH Article 69(2), ECHA are investigating whether the use of these substances in articles is adequately controlled, and if a restriction is needed.
Have your say by 18 August 2023.
For further information please see the ECHA website at the links below:
- Current calls for comments and evidence (ECHA website)
- ECHA's restriction dossiers prepared according to Article 69(2) (ECHA website)
ECHA provides advice on new hazard classes for substances and mixtures
Three new hazard classes for classifying, labelling and packaging (CLP) substances and mixtures entered into force on 20 April 2023. ECHA have published information on the application dates and related guidance.
For further information please click on the link below:
Amending Council Directive 98/24/EC and Directive 2004/37/EC on limit values for lead and diisocyanates
The European Commission has taken action to further improve the protection of workers from the health risks linked to the exposure to the dangerous chemicals lead and diisocyanates. In the case of lead, a significantly reduced exposure limit will help prevent health issues of workers, for example affecting reproductive functions and foetal development. For diisocyanates, a new exposure limit will prevent cases of asthma and other respiratory diseases.
The Commission proposes to amend two Directives:
- For lead, the Directive on the protection of workers from the risks related to exposure to carcinogens, mutagens and reprotoxic substances at work.
- For lead and diisocyanates, the Directive on the protection of workers from the risksrelated to chemical agents at work.
The proposed changes will also be key to protect workers in the context of advancing the transition to climate neutrality says the Commission: both lead and diisocyanates are likely to be used, for example, in the production of batteries and in processes to make electric vehicles lighter, in wind turbines or as insulating materials during building renovations.
Further lowering the exposure limit for lead
Lead can affect sexual function and fertility, and it can harm the development of a foetus or offspring of exposed women. It can also damage the nervous system, the kidneys, the heart and blood of people exposed to it. It is estimated that currently, 100,000 workers in the EU are exposed to lead at work, according to the European Commission's impact assessment. The EU has had occupational exposure limits in place to protect workers from the negative health effects of lead since 1982. On the basis of the latest scientific evidence, the Commission has proposed to:
- Further lower the occupational exposure limit from 0.15 milligrams per cubic meter (0.15mg/m3) to 0.03mg/m3.
- Lower the biological limit value from 70 microgram per 100 millilitre of blood (70µg/100ml) to 15µg/100ml.
While the workforce exposed to lead is predominantly male, female workers may face additional risks as lead can affect pregnant women and the developing foetus. Therefore, the Commission also reiterates that to better protect women, it is paramount to raise awareness among workers of childbearing capacity and put in place specific measures to minimise any possible risks and in addition ensure that the blood lead level in women of childbearing age should not exceed the reference values of the general population not occupationally exposed to lead in the respective Member State. When national reference levels are not available, blood lead levels in women of childbearing age should not exceed the biological limit value of 4.5 µg/100ml.
Introducing first-ever exposure limits for diisocyanates
Diisocyanates describe various chemicals that are often grouped based on their common properties, and which can cause respiratory diseases like asthma. The Commission's impact assessment estimates that currently, 4.2 million workers in the EU are exposed to diisocyanates. There are currently no limit values for diisocyanates at EU level.
The Commission therefore proposes to introduce, for the first time, limit values to protect workers from exposure to diisocyanates at work. These limit values refer to the nitrogen, carbon, and oxygen group of diisocyanates, responsible for their ill-health effects:
- An overall occupational exposure limit of 6µg NCO/m3 (this stands for the maximum concentration of a substance in the air a worker breathes in a certain reference period, 8 hours).
- A short-term exposure limit of 12µg NCO/m3 (this stands for a shorter reference period, 15 minutes. It applies when the negative health effects of a substance cannot be adequately controlled with an overall exposure limit, for instance during short but high intensity exposure).
In addition to the limit values, the Commission proposes so-called “notations”. Notations are indications added to limit values, which alert employers and workers of possible exposure via routes other than inhalation, for example, through the skin, and of the need to implement protective measures.
Next steps
The Commission's proposal will now be discussed by the European Parliament and the Council. Once adopted, Member States will have two years to transpose the Directive into national law.
Lead gunshot banned in wetlands
The EU-wide ban on using lead gunshot in wetland areas starts applying on 16 February 2023.
This restriction harmonises national laws already in place in various forms in 23 EU Member States and introduces new legislation in four EU Member States: Ireland, Poland, Romania and Slovenia. It also implements the international Agreement on the Conservation of African-Eurasian Migratory Waterbirds (AEWA) to protect wetland birds in the EU.
The restriction is expected to protect the environment by reducing lead pollution and preventing the death of around one million waterbirds every year from lead poisoning.
In January 2021, ECHA proposed a broader restriction covering the use of lead in hunting, outdoor sports shooting and fishing. This proposal and the scientific committees’ opinion will soon be sent to the European Commission for decision making.
Please see the following links for more information:
- Commission regulation - (EUR-Lex website)
- Restriction on the use of lead gunshot in wetlands - (ECHA website)
Consequences of the Candidate List Under REACH
Companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.
Suppliers of articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) have to give their customers and consumers information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.
Importers and producers of articles will have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (17 January 2023). Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).
The Candidate List of substances of very high concern for Authorisation can be found at the following link:
Glyphosate: EFSA and ECHA update timelines for assessments
The consultations carried out by the European Food Safety Authority (EFSA) and ECHA on the draft assessments of glyphosate attracted an unprecedented number of comments, confirming the high level of interest in this substance. Such a level of public participation underlines the importance of transparency in the evaluation of active substances in the EU.
The additional information received will be thoroughly considered by the Assessment Group on Glyphosate (AGG), composed of four EU Member States – France, Hungary, The Netherlands and Sweden – that is now updating their initial draft renewal assessment report (dRAR).
Against this background, EFSA and ECHA have revised the timeline for the remaining steps in the re-evaluation process.
- ECHA News (echa.europa.eu)
-
Glyphosate: EFSA and ECHA update timelines for assessments (www.efsa.europa.eu)
N,N-dimethylformamide restriction
The European Commission has published a regulation restricting N,N-dimethylformamide (DMF) – an aprotic solvent used in many industrial applications in the EU. This decision follows the proposal of the Italian authorities and the opinion of the European Chemicals Agengy (ECHA) scientific committees.
The restriction starts applying from 12 December 2023. Some uses have been granted longer transition periods.
We expect that by lowering the levels of DMF at workplaces, 1300 - 2500 workers will be better protected from negative health effects, such as liver and developmental effects and reproductive harm.
For more information please see the following link:
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