03 May April Regulatory Updates
ECHA:
ECHA recommended eight substances for REACH authorisation
– Ethylenediamine;
– 2-(4-tertbutylbenzyl)propionaldehyde and its individual 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.
Biocides:
List of notifications to Review Programme updated
An updated list of substance and product-type combinations notified to Review Programme is now available. It contains the names of the notifying companies to help you collaborate when submitting an application for active substance approval. This can help you avoid unnecessary testing on animals.
Member States’ plans to submit assessment reports
It has been published a table with an overview of dates when evaluating competent authorities are planning to submit assessment reports for biocidal active substance approvals or renewals. The Biocidal Products Committee assesses these reports in their opinion-forming. The table will be updated regularly.
Commission decisions on Union authorisations
The European Commission has granted Union authorisations for:
- Biocidal product family C(M)IT/MIT formulations
- Single biocidal product Arche Chlorine
REACH:
EU member states approve microplastics restriction proposal
EU member states have approved the European Commission’s proposal to restrict intentionally added microplastics in products.
The Commission can now send the proposal to the European Parliament and the Council, which have three-month to analyze the text. If they do not raise objections within that time period, the proposal will enter into force.
The EU executive set out the scope of the restriction in a draft published last September, after nearly six years in the making. The proposal is regarded as being one of the most complex chemical bans prepared in the EU.
The Commission’s latest draft made some amendments to ECHA’s prior proposal,which include allowing an increase in the size of particles covered, more generous transition periods of up to 12 years and exemptions for uses at industrial sites and medicinal products.
Industry has welcomed the more realistic deadlines set out in the proposal to allow for the development of alternatives, and the exclusion of soluble or biodegradable polymers. But it continues to regard the scope as being too broad and difficult to enforce, with methods to detect microplastics in products yet to be agreed.
European Commission considers future polymer registration plans
The European Commission keep on discussing information requirements and timelines for polymer notification and registration under REACH while stakeholders anxiously wait for the publication of the delayed revision proposal for the Regulation.
The REACH revision proposal, due by the end of the year, will contain the basic provisions for polymers. However, the exact details of what information registrants should submit in the registration phase is not likely to be part of the proposal this year.
Meanwhile, the Commission has come up with several options. One of these, concerning registration, is that after the amended Regulation enters into force, companies would have at least eight years to register low molecular weight (MW) polymers (type 1), and at least 12 years for medium and high MW polymers (types 2 and 3). Collectively they are known as polymers requiring registration (PRRs) and would be those manufactured or imported in quantities above one tonne a year.
There are between 70,000 and 400,000 polymers on the EU market with a figure of 200,000 used as a “working average”. With the scope of helping industry and ECHA process registrations for this vast number, the Commission will ask for polymers to be registered in groups. For these, the idea would be that the group and total tonnage determines the tonnage threshold.
A mandatory notification phase will precede the registration stage. The Commission’s current thinking is that after the Regulation’s entry into force, notifications must be made immediately for new polymers, whereas companies with those substances already on the market will have three years to notify.
While the exact type of information companies must deliver is to be determined, it could include:
- Basic identification (names and identifiers);
- Chemical composition of polymeric and non-polymeric parts;
- Structural information;
- Information allowing Echa to define grouping criteria; and
- Optional information, such as physico-chemical, (eco)toxicological, environmental fate, and bioavailability properties.
Notification and registration overview
Step 1: notification (PRR/non-PRR identification and information required for grouping) for all manufactured or imported polymers above one tonne
Step 2: Echa defines grouping criteria
Step 3: grouping by industry
Step 4: registration for type 1 PRRs
Step 5: registration for PPR types 2 and 3
Derogations possible for fluoropolymers in EU PFAS restriction proposal
The relevant authorities could consider derogations for fluoropolymers in the EU’s universal PFAS restriction proposal if it can be proven that they degrade at the end of their lifecycle.
the EU proposal aims for a full ban, including polytetrafluoroethylene (PTFE), the most prominent one in the group with a wide range of applications, including non-stick coating on pots and pans, wire insulation for aircraft parts and lubrication products for musical instruments.
The EU proposal derogates applications such as medical devices that are manufactured from PTFE due to a lack of alternatives.
The fluoropolymers industry has objected to the inclusion of the chemicals in the scope of the restriction proposal.
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