#biocides Tag

07 Nov

Posted at 10:55h in Blog, Regulatory Updates

Recent Regulatory Developments in Biocidal Active Substances:

The European Union has recently published a series of regulatory updates concerning the approval and non-approval of certain active substances for use in biocidal products.

 

Approvals Granted

Two implementing regulations have been published, approving a complex reaction mass of various ammonium propionate compounds for use in biocidal products:

  • Implementing Regulation (EU) 2023/2088 approves the substance for use in product-type 8 biocides, effective from October 19, 2023. This active substance was previously approved under a different name, which has now been updated to reflect its correct chemical identity.
  • Implementing Regulation (EU) 2023/2089 extends the approval to include product-types 2 and 4 biocides, also effective from October 19, 2023.

 

Non-Approvals Announced

Conversely, two decisions have been made to not approve certain active substances:

  • Implementing Decision (EU) 2023/2052 does not approve silver sodium hydrogen zirconium phosphate for use in product-type 4 biocides, with the decision taking effect on October 16, 2023.
  • Implementing Decision (EU) 2023/2377 does not approve silver and copper zeolite for use in product-type 4 biocides, effective from October 23, 2023.

 

Extensions on Approval Expiry Dates

The European Commission has also published decisions to extend the approval expiry dates for several active substances pending renewal decisions:

  • Implementing Decision (EU) 2023/2100 extends the approval of copper (II) oxide for product-type 8 biocides until October 19, 2023.
  • Implementing Decision (EU) 2023/2378 extends the approval of alfa-chloralose for product-type 14 biocides until October 23, 2023.
  • Implementing Decision (EU) 2023/2380 extends the approval of basic copper carbonate for product-type 8 biocides until October 22, 2023.
  • Implementing Decision (EU) 2023/2386 extends the approval of copper hydroxide for product-type 8 biocides until October 22, 2023.

These extensions have been granted as applications for renewal were submitted in a timely manner, and the decisions on renewal are pending.

 

REACH:

  • The European Chemicals Agency (ECHA) is preparing to propose restrictions on certain high-concern chromium (VI) substances, currently listed for authorization under REACH. This action, requested by the European Commission, is to manage the heavy workload from numerous authorization applications and to prevent potential resource strain on ECHA’s risk assessment committees. The proposal, due by October 2024, could lead to the removal of these substances from the REACH Authorisation List for the first time. The substances are known carcinogens and have other serious health risks, commonly used in electroplating. Companies affected by these potential restrictions can consult a Q&A document published by the Commission for guidance.
  • Switzerland is set to update its chemical regulations to exempt specific uses of five substances listed under the EU’s REACH Annex XIV. The Swiss Federal Office for the Environment (FOEN) aims to align more closely with EU regulations by amending the Chemical Risk Reduction Ordinance (ORRChem). This change, which was reported to the WTO at the end of October, involves adding these substances to a Swiss annex that mirrors the EU’s authorization requirements for Substances of Very High Concern (SVHCs).
  • The substances in question include three that are toxic to reproduction: tetraethyllead (used in fuels), DOTE (used in polymers), and a reaction mass of DOTE and MOTE.
  • The other two are a carcinogen used in inks and toners, known as:4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol (with traces of Michler’s ketone or Michler’s base), and an endocrine disruptor for the environment, which is a reaction product of certain chemicals (with a specific percentage of 4-heptylphenol).
  • The updated regulation is expected to be officially adopted on the first day of the new year and will come into effect on January 1, 2027. This follows a previous amendment in April where Switzerland granted exemptions for the use of SVHCs in the pharmaceutical and aircraft industries.

 

EU Parliament Votes for Stricter Asbestos Exposure Limits:

  • The European Parliament has taken a significant step towards enhancing worker safety by voting to reduce the occupational exposure limit (OEL) for asbestos by ten times. The new directive, which garnered overwhelming support with 614 votes in favor, aims to lower the OEL from 0.1 to 0.01 fibers per cubic centimeter. This move is part of the EU’s broader strategy to combat the risks posed by asbestos, a known carcinogen.
  • The directive mandates stringent measures, including the use of protective gear, specialized respiratory equipment, and comprehensive training for workers dealing with asbestos. Additionally, within six years, EU member states are required to provide workers with advanced electron microscopes capable of detecting asbestos fibers at the new lower concentration levels.
  • Despite this progress, some organizations, like the European Trade Union Confederation (ETUC), argue that the new OEL still falls short of the more stringent 0.001 fibers per cm³ level recommended by the International Commission on Occupational Health (ICOH).

 

EU Commission Revokes Sodium Dichromate Authorization:

  • In another regulatory development, the European Commission has withdrawn an authorization for Gruppo Colle to use sodium dichromate in wool dyeing. This decision follows a review that identified available alternatives to the substance, which is classified as a Substance of Very High Concern (SVHC) due to its carcinogenic nature.
  • The Commission’s action aligns with the European Chemicals Agency’s (ECHA) socio-economic assessment committee’s (SEAC) findings, which highlighted deficiencies in Gruppo Colle’s substitution plan. The authorization’s withdrawal is part of the EU’s ongoing scrutiny of SVHCs, particularly chromium VI compounds, and follows a trend of moving from authorization to restriction to minimize the use of hazardous substances.

 

Cosmetic Safety Limits for Methyl Salicylate in Children’s Products:

  • Lastly, the European Commission’s Scientific Committee on Consumer Safety (SCCS) has confirmed concentration limits for methyl salicylate in cosmetics for children. The final opinion sets specific maximum concentrations for various products, such as shower gels, shampoos, and creams, for children aged six months to three years. Methyl salicylate, commonly used for fragrance and flavoring, is restricted due to its classification as reprotoxic.
  • These regulatory updates reflect the EU’s commitment to safeguarding public health and the environment by tightening controls on hazardous substances and ensuring safer working conditions across the Union.

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03 May

Posted at 10:20h in 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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18 Apr

Posted at 08:30h in Chemical

the new guidance helps companies analyse alternatives under the Biocidal Products Regulation for potentially dangerous active biocidal substances

Currently, there are 59 biocidal active substances identified as “candidates for substitution” (CfS) under the BPR (Art.10), and 441 active substances under assessment.

Article 5 of the BPR ensures that, during the evaluation of an application for active substance approval, active substances will be assessed against exclusion criteria which have been set to phase out substances which raise particular concerns. Active substances meeting one of such criteria shall not be approved unless at least one of the conditions set out in Art. 5(2) of the BPR is met. Art.5(2) specifies that the availability of suitable and sufficient alternative substances or technologies shall be a key consideration when deciding on the approval of substances meeting the exclusion criteria. In this sense, the submission of an analysis of alternatives by the applicant is required.

When substances meet at least one of the criteria for substitution, but do not meet any of the exclusion criteria, a comparative assessment at biocide product level is performed by the relevant competent authority. The placing on the market of the biocidal products containing an active substance which is CfS shall be prohibited/restricted in case the comparative assessment demonstrates that suitable alternatives are available. The submission of an analysis of alternatives by applicants for approval/renewal of such active substances is not legally required but strongly recommended to support the comparative assessment at product authorisation stage.

The ECHA guidance “Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance”, released on last January, is primarily aimed at:

  • The applicants to support their application for approval/renewal of a biocidal active substance meeting the exclusion/substitution criteria, and
  • The competent authorities willing to perform an analysis of alternatives for such active substances.

An alternative to a biocidal active substance is a means able to replace the function that the active substance performs, and it must fulfil the following criteria:

  • Safer, i.e. it reduces the risk to human health, animal health and the environment, and
  • Technically and economically feasible for the users in the EU (including efficacy), and
  • Available, from the perspective of production capacities, or of feasibility of the alternative technology.

The alternatives can be chemical substances or non-chemical alternatives (non-chemical means of control and prevention methods). Non-chemical alternatives can be e.g. physical means of achieving the same function of the biocidal active substance, or organisational procedures, preventive measures, devices, changes in a product manufacturing process, changes in the end-product, changes in the material of the end-product (e.g. steel pole instead of wooden pole), etc.

Overall, the analysis of alternatives should comprise:

  • A brief description of the steps taken to identify potential alternatives.
  • The main conclusions of the analysis regarding the identification of potential alternatives and the suitability and availability of these alternatives for the identified uses
  • If there are no or insufficient suitable alternatives, a summary of the actions needed to make potential alternatives suitable and available and the timescale for these actions.

For further details, you can download the guidance here: https://echa.europa.eu/documents/10162/1276600/guidance_analysis_alternatives_biocides_en.pdf/10646cd2-8ec9-36a8-2f00-201fcc49c43e?t=1675846602684

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