The following news story provides information on Chemical Regulation in Northern Ireland
Consultations on SEAC draft restriction opinions
The European Chemicals Agency (ECHA) are inviting stakeholders to comment on the draft opinions of the Committee for Socio-Economic Analysis (SEAC) concerning restriction proposals for:
- per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams
(EC -, CAS -). - N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)
(EC -, CAS -) - Terphenyl, hydrogenated (EC 262-967-7, CAS 61788-32-7)
Comments are welcome by 15 May 2023. To give comments please see the following link:
Submitted restrictions under consideration - (ECHA website)
Join ECHA`s webinar on the new data availability system
19 April 2023
11.00am to 12.00pm (Helsinki time)
ECHA are building a new data availability system, with the new solution rolled out gradually starting with REACH registration data at the end of this year. The webinar will let you know what to expect and help you prepare for the changes.
Follow our webinar at 11:00am on 19 April 2023.
For more information please see the following link:
Consultations on harmonised classification and labelling
The European Chemicals Agency (ECHA) are looking for comments on the harmonised classification and labelling proposals for:
- 2-hydroxyethyl methacrylate; [HEMA] (EC 212-782-2,
CAS 868-77-9) - pyriproxyfen (ISO); 2-(1-methyl-2-(4-phenoxyphenoxy)ethoxy)pyridine; 4-phenoxyphenyl (RS)-2-(2-pyridyloxy) propyl ether (EC 429-800-1, CAS 95737-68-1)
- methacrylic acid, monoester with propane-1,2-diol; [HPMA]
(EC 248-666-3, CAS 27813-02-1)
The deadline for comments is 12 May 2023. To give comments please see the following link:
Consultations on harmonised classification and labelling
ECHA are looking for comments on the harmonised classification and labelling proposals for:
- Calcium tetraborate (EC 234-511-7, CAS 12007-56-6);
- Calcium metaborate (Ca(BO2)2) and calcium tetraborate (CaB4O7), amorphous reaction products of boric acid with lime (EC -, CAS -);
- Pentaboron sodium octaoxide (EC 234-522-7, CAS 12007-92-0) ;
- Sodium metaborate, anhydrous [1]; boric acid (HBO2), sodium salt, tetrahydrate [2]; and any other hydrated form (EC 231-891-6 [1]; - [2], CAS 7775-19-1 [1]; 10555-76-7 [2]);
- Diammonium decaborate (EC 234-521-1, CAS 12007-89-5) ;
- Potassium metaborate (EC 237-262-2, CAS 13709-94-9) ;
- Dipotassium tetraborate (EC 215-575-5, CAS 1332-77-0);
- Magnesium metaborate (EC 237-235-5, CAS 13703-82-7) ;
- Dipotassium octaborate (EC -, CAS 12008-39-8); and
- Potassium pentaborate (EC 234-371-7, CAS 11128-29-3).
The deadline for comments is 5 May 2023.
Further information can be found at the ECHA website at the link below:
Testing proposals
The European Chemicals Agency (ECHA) have launched 11 new consultations on testing proposals.
The deadline for comments is 17 April 2023.
To provide comments please see the following link:
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.
Two proposals to identify new substances of very high concern
The substances and examples of their uses are:
- bis(4-chlorophenyl) sulphone (EC 201-247-9, CAS 80-07-9). Used for the manufacture of chemicals, plastic products and rubber products.
- diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (EC 278-355-8, CAS 75980-60-8). Used in inks and toners, coating products, photo-chemicals, polymers, adhesives, sealants, fillers, putties, plasters, and modelling clay.
The deadline for comments is 3 April 2023.
To read more please click on the link below:
Call for evidence on presence of CMRs in childcare articles
To protect children, the European Commission is planning to prepare a REACH restriction proposal on carcinogenic, mutagenic and reprotoxic (CMR) substances in childcare articles. The European Chemicals Agency (ECHA) are helping the Commission by preparing an investigation report.
ECHA are now asking interested parties to send us information on the potential presence of CMRs (categories 1A or 1B) in childcare articles.
This call for evidence is open until 31 March 2023. ECHA's report is expected to be ready in September 2023.
Please see the following links for more information:
- Current calls for comments and evidence - (ECHA website)
- European Commission Mandate - PDF format - (ECHA website)
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)
ECHA has launched a consultation on 13 applications for authorisation covering 14 uses of:
- Chromium trioxide (EC 215-607-8, CAS 1333-82-0): used in functional chrome plating, functional chrome plating with decorative character, passivation of electrolytic tinplate (ETP)
- Sodium dichromate (EC 234-190-3, CAS 10588-01-9): passivation of electrolytic tinplate (ETP)
- 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -): manufacturing aid in the production of gene therapies
More details about the functions of the substances, the uses applied for, exposure scenarios, possible alternatives, and socio-economic information are available on ECHA's website.
Submit comments by 12 April 2023.
Please see the following link for more information:
Call for evidence: Investigation report on PVC and PVC additives
The European Commission has asked us to prepare an investigation report on polyvinyl chloride (PVC) and PVC additives.
ECHA are requesting interested parties to submit any information they have related to some PVC additives and additives used in alternative plastics.
This call for evidence is open until 31 March 2023.
For more information please see the following link:
ECHA are looking for comments on the harmonised classification and labelling proposals for:
- fosthiazate (ISO); S-sec-butyl O-ethyl (2-oxo-1,3-thiazolidin-3-yl)phosphonothioate (EC 619-377-3, CAS 98886-44-3)
- tetra(sodium/potassium)7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4- fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl} amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5- methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate; [substance having a complex composition with <80% of the above constituents and other reaction side products]; Reactive Brown 51 (EC 466-490-7, CAS -)
The deadline is 31 March 2023.
For more information please see the following link:
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:
New approach methodologies workshop: Towards an animal free regulatory system for industrial chemicals
31 May - 1 June 2023, Helsinki
ECHA are organising a workshop to discuss the critical needs for transitioning to an animal-free regulatory system. The goal is to bring together stakeholders and develop a shared understanding of the potential short- and long-term benefits of new approach methodologies. The workshop is part of ECHA`s commitment to support the transition to an animal-free regulatory system.
For more information please follow the link below:
Consultation on proposed restriction of bisphenol A and other bisphenols
Germany has submitted a proposal to restrict the placing on the market of mixtures and articles containing bisphenol A, other bisphenols and bisphenol derivatives (BoSC – BPB, BPS, BPF and BPAF) with endocrine disrupting properties for the environment.
This consultation is open from 21 December 2022 to 22 June 2023 (23:59 Helsinki time).
Our scientific committees welcome early comments by 25 January 2023 to help them in the first discussion of the proposal in March 2023.
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:
Latest news
- Latest chemicals news for Northern Ireland - updated 23 March 2023 23 March 2023
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