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zaterdag 24 juni 2017

HSE eBulletin service Daily Digest Bulletin

HSE e-Bulletin service
Biocides e-bulletin: Biocides Adverse or Unexpected Effects Survey 2017 & EU BPR approval updates

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Biocides eBulletin

 
 

Welcome to the HSE Biocides eBulletin

This e-bulletin is from HSE's biocides team


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Biocides Adverse or Unexpected Effects Survey 2017

THE CONTROL OF PESTICIDES REGULATIONS 1986 (COPR) (AS AMENDED)

THE CONTROL OF PESTICIDES REGULATIONS (NORTHERN IRELAND) 1987 (AS AMENDED)

THE BIOCIDAL PRODUCTS REGULATION (BPR):  REGULATION (EU) NO. 528/2012

In July, HSE will be writing to all biocidal product Approval /Authorisation holders to request information they may hold concerning adverse or unexpected effects associated with the use of their products. We will require any information relating to adverse or unexpected effects that have not already been reported to HSE.

Biocides regulations place a duty on all Approval /Authorisation holders to provide these reports to HSE at the time they arise. This duty also includes reports that indicate that the product(s) is not sufficiently effective or is contributing to the development of resistance in pests. This annual request for information will assist Approval /Authorisation holders by providing an easy method for them to fulfil this legal requirement. Where Approval /Authorisation holders have already alerted HSE to any adverse or unexpected effects, or already have agreed arrangements in place, they will not be expected to provide duplicate information.

Please note that adverse or unexpected effects associated with the use of biocides should continue to be reported to HSE and other relevant bodies as soon as possible following receipt of a report. This information is an essential part of the regulations and a vital part of managing the risks that may arise from the use of biocidal products.

HSE's request and supporting advice will be communicated directly to individual Approval/Authorisation holders in July 2017. No action is required in advance of receiving this request.


Biocides Regulation 528/2012 (EU BPR) – Biocidal Products Committee adopts 6 opinions on active substances

At its 20th meeting (27 April 2017), the Biocidal Products Committee (BPC) adopted opinions supporting the approval of two active substances for use in biocidal products used as disinfectants. The active substances are:

  • Propan-2-ol for product-types 1, 2 and 4
  • L(+) lactic acid for product-types 2, 3 and 4.

The adopted opinions will serve as a basis for final decision-making by the European Commission and the Member States.

For more information, for example on the safe use(s) that have been identified during the active substance evaluation, please see the News alert.

Details of previous BPC active substance opinions can be found on the ECHA website.


Biocides Regulation 528/2012 (EU BPR) – List of active substances in the Review Programme updated

The list of biocidal active substances to be evaluated by Member States has been updated. The updated Annex II to the Review Programme Regulation includes a list of the active substances that companies have requested to get approved for a specific product-type. 

If a substance is on the list for your product-type, your product can stay on the EU market while you wait for the substance to be approved. 

If a substance is no longer included in the Review Programme for your specific use, it means that no company has expressed an interest in keeping it there or the notification has not fulfilled the requirements. The European Commission has adopted a non-approval decision for these substances. According to the decision, the substances can no longer be made available on the EU market after 28 November 2017 and no longer used after 28 May 2018. 

The European Commission updated the Review Programme Regulation in February. The regulation entered into force on 9 May 2017.

Further information can be found on the ECHA website (News alert).

Please note the corresponding dates published on the ECHA website are currently incorrect.


Biocides Regulation 528/2012 (EU BPR) - Active Substance Approval Reminder

The following active substance has been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

It will be approved for use in biocidal products placed on the EU market, on 1 October 2017. Biocidal products containing this active substance will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 October 2017 in order to keep their biocidal products on the UK market after the active substance approval date, 1 October 2017. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 October 2017 for a biocidal product containing this active substance, the biocidal product shall no longer be made available on the UK market after 30 March 2018. Disposal and use of existing stocks of the biocidal product may continue until 1 October 2018.  If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.  

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s).   

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.


EU Biocides Regulation 528/2012 (EU BPR) - Active Substance Approval

The following active substances have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided to approve them for use in biocidal products placed on the EU market. Biocidal products containing these active substances will therefore need to obtain EU BPR authorisation if they are to remain on the market.

These substances will be added to the Union list of approved active substances (formerly Annex I of Directive 98/8/EC) for use in biocidal products and treated articles on 1 November 2018. Companies wishing to place biocidal products on the EU market containing these active substances, in the relevant product type, must apply for product authorisation by 1 November 2018. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.  

If no application for product authorisation in the UK is made by 1 November 2018 for a biocidal product containing the above active substances, the biocidal product shall no longer be made available on the UK market after 30 April 2019. Disposal and use of existing stocks of the biocidal product may continue until 1 November 2019 

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the UK Control of Pesticides Regulations (COPR), which are affected by the approval of the above active substance(s).   

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.


EU Biocides Regulation 528/2012 (EU BPR) – PHMB (1600; 1.8) Non-Approval Decision

The following active substance has been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided not to approve it for use in biocidal products made available on the EU market.

All affected companies are reminded that biocidal products containing this active substance, in product type 5,

  • shall no longer be made available on the market after 31 May 2018; and
  • use of existing stocks of the biocidal product may only continue until 30 November 2018

Companies must manage the supply of the affected product(s) to ensure there will be none remaining in the EU supply chain by 31 May 2018.

If the biocidal product was approved under the UK Control of Pesticides Regulations (COPR), affected companies will receive a certificate to revoke the COPR approval in line with the above dates.


    ECHA - Public Consultation – proposals for NEW harmonised classification and labelling for Pyrithione zinc (biocidal active)

    ECHA has invited interested parties to comment on proposals for new harmonised classification and labelling (CLH) for:

    pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc (EC 236-671-3; CAS 13463-41-7):

    This substance is used as an active substance in biocidal products, and also used or intended to be used in cosmetic products, as a disinfectant and as a preservative in e.g. construction materials, films, fibres, leather and polymerised materials. It has no existing harmonised classification and labelling in Annex VI.

    Comments are invited on all physical, human health and environmental hazard classes except respiratory sensitisation, aspiration hazard and hazardous to the ozone layer.

    Comments should be submitted to ECHA by 7 July 2017.

    To view the consultation, please visit the ECHA website.


    New proposals and intentions to harmonise classification and labelling of biocidal active substances

    Proposals have been submitted to ECHA for:

    • Pyrogenic, synthetic amorphous silicon dioxide, nano, surface (EC 272-697-1, CAS 68909-20-6).
    • Lavender, Lavandula hybrida, ext. (EC 294-470-6, CAS 91722-69-9).
    • Azoxystrobin (ISO); methyl (2E)-2-(2-{[6-(2-cyanophenoxy)pyrimidin-4-yl]oxy}phenyl)-3-methoxyacrylate (CAS 131860-33-8).

    Current CLH intentions and Submitted CLH proposals are available on the ECHA website.

    Interested parties can now prepare for the upcoming commenting/consultation period which ECHA will initiate.


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