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donderdag 9 februari 2017

HSE eBulletin service Daily Digest Bulletin

HSE e-Bulletin service
HSE eBulletin service Equipment at work Update
 

Latest automated update(s) to Equipment at work on HSE's Website:

27-01-2017 03:29 PM GMT

This course covers those activities regulated by the Provision and Use of Work Equipment Regulations (PUWER) and provides delegates with a thorough knowledge of this legislation. The course will also give practical advice on how to evaluate the safety of existing machines and how to measure and evaluate noise and vibration risks.
 
University of Northumbria fined after botched experiment nearly kills students

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Weekly digest eBulletin

 
 

Welcome to HSE's Weekly Digest eBulletin

This bulletin is just a sample of what's new on HSE's website this week. The site is updated daily - visit What's New at hse.gov.uk
News  

News

University of Northumbria fined after botched experiment nearly kills students

 

Work at height

Firms fined after worker killed falling from telehandler

 

Asbestos

Asbestos removal firm fined after poor safety practices

 

Hazards at work

Overhead crane worker suffers life threatening injuries

Waste company fined after worker run over

 

Health and Safety Myths

Lady faints in a shop and refused a glass of water due to health and safety

Job Advert stated that Bus Drivers weight must be below 18 stone

 

Events

Refurb health and safety event for construction workers - Wishaw, 14 Feb 2017

PPE Essentials - Buxton, 14-15 March 2017

RPE Essentials - Buxton, 21-22 March 2017

RPE Fit Test Introduction - Buxton, 23 March 2017

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Biocides e-bulletin: Vertebrate data in support of applications for AS approval and product authorisation; classification and labelling proposals; Food & Feed AS deadline for notification for inclusion in EU BPR review; Boron-based Wood Preservatives – request for information on current use and the potential impact of changing to alternatives

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Biocides eBulletin

 
 

Welcome to the HSE Biocides eBulletin

This e-bulletin is from HSE's biocides team


Stay up-to-date with upcoming biocides deadlines

 

Vials and molecular structure  

EU Biocides Regulation 528/2012 - Vertebrate data in support of applications for active substance approval and product authorisation

HSE's biocides website has been updated to reflect the position of the UK Comptetent Authority (CA) for biocides on the acceptability or not of vertebrate data to support applications under EU 528/2012, as outlined in articles 62/63 of BPR. For more information, see: HSE biocides website: Vertebrate testing in support of applications for active substance approval or product authorisation under the Biocidal Products Regulation (528/2012)

Pesticides:  Please note this position applies only to biocides. For information on vertebrate studies to support an application under Regulation (EC) No. 1107/2009, please consult the HSE pesticides website: Vertebrate Testing.


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

Proposals have been submitted to ECHA for:

  • Esbiothrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-en-1-yl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate (CAS 260359-57-7),
  • d-Allethrin; (RS)-3-allyl-2-methyl-4-oxo-cyclopent-2-enyl-(1R,3RS)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (CAS 231937-89-6).

Submitted CLH proposals on ECHA website

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


Food & Feed Active Substances – 24 February 2017 deadline for notification for inclusion in the EU Biocidal Products Regulation (EU BPR) review programme - reminder

Background

Where a biocidal product based on food or feed active substances had originally benefitted from a derogation under the Biocidal Products Directive 98/8/EC (BPD) review programme, industry had to make a declaration of an 'Interest to Notify' the active substances for inclusion in the EU Biocidal Products Regulation review programme.

Those declarations had to be made to the European Chemicals Agency (ECHA) by 30 October 2015.

Based on the valid declarations received by the deadline, ECHA published a list of the 20 substances that are eligible to be notified for inclusion in the review programme as Product Type 19 attractants or repellents. If the food or feed active substance is not listed, the product should have been removed from the UK market by 30 October 2016, and the use of existing stocks of the product in the UK can continue until 30 April 2017. Products that previously held derogations in the UK that are affected by these phase-out periods are listed on our database. 

What action does Industry need to take now?

Industry has to officially notify the eligible active substances (in accordance with Article 17 of the EU BPR Review Regulation (1062/2014)) to ECHA by 24 February 2017.

Notification should be submitted via the biocides submission tool, R4BP. The application must be in IUCLID format and must contain the information outlined in Annex I to the EU BPR Review Regulation (1062/2014)).

Further guidance on the information requirements for food and feed active substances can be found on ECHA's website. 

Valid notification received

If a valid notification is received by the 24 February 2017 deadline, the European Commission will have the final decision on whether to include a substance in the Review Programme. If accepted, the notifier(s) has two years to submit their active substance dossier.

Existing food and feed products can continue to be made available on the UK market if a valid notification is received by the 24 February 2017 for active substance(s) in their products. It can also continue to be made available on the UK market if the active substance dossier is submitted.

If no valid active substance dossier is received, or received but rejected, the existing food and feed products containing those substances will have to be removed from the UK market within the deadlines set by the EU Commission, normally 12 months for making the biocidal product available on the market and 18 months for use of the biocidal product.

No valid notification is received or received but rejected

If no valid notification is received or received but rejected by the 24 February 2017 deadline, the existing food and feed products containing those substances will have to be removed from the UK market within the deadlines set by the EU Commission, normally 12 months for making the biocidal product available on the market and 18 months for use of the biocidal product. These phase out periods will start from the date ECHA publishes its the list of these substances, in accordance with Article 19 of the EU BPR Review Regulation (1062/2014)).


Boron-based Wood Preservatives – request for information on current use and the potential impact of changing to alternatives

HSE is currently assessing whether a number of wood preservative (PT8) products based on boron can be authorised for use in the UK under the EU Biocidal Products Regulation (BPR).

As the boron compounds boric acid, boric oxide, disodium octaborate and disodium tetraborate now carry a Reproductive Toxicity hazard classification, they meet the exclusion criteria in Article 5(1) of the BPR. In line with Article 5(2)c of the BPR, HSE is now assessing the impact on society of not authorising affected products, as well as assessing the risks to human health, animal health and the environment from their continued use.

Therefore we are inviting stakeholders to submit information on the use of the following types of boron-based wood preservative product:

  1. Products for the remedial treatment of insect and fungal infestation in wooden transmission poles, in particular poles pre-treated with creosote
  2. Products for treating wood to prevent wood destroying insects
  3. Products for treating wood to prevent wood staining fungi
  4. Products for treating wood to prevent wood destroying fungi

In particular we welcome information on:

A) The current scale of use of boron-based wood preservatives in the UK,

B) Alternatives to boron-based wood preservatives, and the

C) Potential economic and other implications for users in the UK having to change to these alternatives. 

A) The current scale of use of boron-based wood preservatives in the UK

We welcome information on:

  • Annual tonnages or  % of market share of any boron-based products in the UK.
  • Any particular benefits/properties that make boron-based wood preservatives a particular choice for their authorised uses.

B) Alternatives to boron-based wood preservatives

Potential alternatives could be either boron-free wood preservatives, non-biocidal treatment methods, or use of materials other than wood for the relevant applications. We welcome information on the technical advantages and disadvantages of these alternatives in comparison to boron-based wood preservative products. This could include, for example:

  • What alternatives are available and are these already in use?
  • Do these alternatives have any detrimental effects on the technical properties of materials they are used to treat?
  • What changes need to be made to uses/processes that currently use boron based products?

C) Potential economic and other implications for users in the UK having to change to these alternatives

We welcome information on:

  • Predicted demands for boron-based wood preservative products over the next 5 years.
  • Estimates of ongoing costs of alternatives compared to boron-based treatments
  • Estimates of any direct costs of changing to alternative products, treatments or materials
  • Estimates of any costs of purchasing new application equipment or retraining staff, or other investment costs associated with the use of alternatives.
  • Where alternatives are available, whether there are any sector-specific requirements or legislation which could affect changing.
  • If there is no alternative to a boron-based wood preservative use, any direct and indirect costs of wood products having a potentially reduced function or service life.

Further information on the authorisation of biocidal products under the EU BPR is available on HSE's biocides website.

Submitting information

We would be grateful if stakeholders could submit this information by March 3rd 2017 either:

  • by email to pa.biocides@hse.gov.uk with "BORON PT 8 STAKEHOLDER INFO" in the title field, or
  • by post to Biocidal Products Team, CRD, Health and Safety Executive, 5S1 Redgrave Court, Merton Road, Bootle, Merseyside, L20 7HS.

Could stakeholders also state which wood preservative use information is being provided for (i.e. the remedial treatment of wooden transmission poles, or the pre-treatment of wood to prevent attack by wood destroying insects, wood staining fungi or wood destroying fungi), and give a brief description of any role their organisation has in the use of wood preservatives or wood products in the UK?

A summary of the information received with the names of all individuals, organisations and products removed will be made available in due course.


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Pesticides e-bulletin: Active substance approvals: February 2017; CRD Events -Two Day Consumer Risk Assessment Workshop

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Pesticides eBulletin

 
 

Welcome to the HSE Pesticides eBulletin

This e-bulletin is from HSE's pesticides team

Tractor  

Active substance approvals: February 2017

Regulatory Update: 04/2017

Issued:  8th February 2017

Updating your authorisation

HSE does not directly notify product authorisation holders where a change or update of a current authorisation is required because of a change by the EC to an approval of an active substance.  Authorisation holders are advised to check the EU Pesticides database where new or changes to active substance approvals and review reports are published.

Active substance approvals

At the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) it was agreed:

To approve under Regulation (EC) 1107/2009:

  • Prosulfuron AIR2 as a candidate for substitution 
  • the low-risk active substances Mild Pepino Mosaic Virus isolates VC1 and VX1
  • abamectin, buprofezin and oxyfluorfen: Amendment of approval conditions
  • acrinathrin: Confirmation of the conditions of approval
  • clayed charcoal, Urtica spp. and hydrogen peroxide (as basic substances)

Prosulfuron as a candidate for substitution

Prosulfuron was considered under the second stage of the renewal programme (governed by Commission Regulations 1141/2010).  Authorisations for products containing this substance will need to be renewed in accordance with Article 43 of Regulation (EC) 1107/2009, with applications required by 31 July 2017.  For further information see Guidance on UK Procedures for product renewal applications

Prosulfuron was also found to be a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Prosulfuron is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water is greater than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0.01 mg/L.

Mild Pepino Mosaic Virus isolates VC1 and VX1

Mild Pepino Mosaic Virus isolates VC1 and VX1 were considered low-risk active substances pursuant to Article 22 of Regulation (EC) No 1107/2009.  Mild Pepino Mosaic Virus isolates VC1 and VX1 fulfil the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

Abamectin, buprofezin and oxyfluorfen amendment of approvals  

The column 'Specific provisions' of abamectin, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is to be replaced by the following:

'Only uses as insecticide, acaricide and nematicide may be authorised.'

The column 'Specific provisions', of buprofezin, of the Annex to Implementing Regulation (EU) No 540/2011 is to replaced by the following:

'PART A

Only uses as insecticide and acaricide on non-edible crops may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

  • the operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate;
  • the application of an appropriate waiting period for rotational crops in greenhouses;
  • the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate.

Conditions of authorisation shall include risk mitigation measures, where appropriate.'

 

The column 'Specific provisions' of oxyfluorfen, the Annex to Implementing Regulation (EU) No 540/2011 is to be replaced by the following:

'PART A

Only uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

  • operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate;
  • the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.

Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.'

Acrinathrin (confirmation of approval conditions)

The review report for acrinathrin laid out specific concerns that led to the restriction of the use of acrinathrin at rates not exceeding 22,5 g/ha per application. In particular, acrinathrin is very toxic to fish and aquatic invertebrates and its acceptability on the basis of the current rates already require extensive risk mitigation.  New data provided by the applicant failed to demonstrate that the envisaged significant increase of rates, and consequently, of exposure, would result in an acceptable risk to aquatic organisms.  Finally, on the basis of confirmatory information submitted by the applicant, EFSA concluded that the higher rates would induce a high risk to non-target arthropods, which further confirms that rates of application cannot be increased.  The conditions of approval of the active substance acrinathrin, as set out in Part B of the Annex to Implementing Regulation (EU) No 540/2011, are therefore retained.

Clayed charcoal, Urtica spp. and hydrogen peroxide

These were approved as basic substances for an unlimited period according to the criteria under Article 23 of Regulation (EC) 1107/2009. 

Contact Details

If you have any questions relating to this Regulatory Update, please contact us:  Link to Contact details page.


Vertebrate data used for pesticide authorisations

Regulatory Update: 03/2017

Originally Issued: 25 January 2017 (this is a slightly revised version of the original update)

Purpose

In vivo vertebrate tests should not be conducted for the purposes of fulfilling the requirements of Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market) where accepted alternatives are available and could reasonably have been used.

This update reminds applicants and testing facilities of their duties under Regulation (EC) No. 1107/2009 ('the Regulation') to avoid vertebrate testing and to use alternative methods, and also confirms that HSE will not accept in vivo studies where an accepted alternative is available.

This is a reminder of existing requirements so applies with immediate effect.

Background

Regulation (EC) No. 1107/2009 aims to minimise vertebrate testing.  When new, alternative OECD Test Guidelines become available that can fully or partially replace in vivo tests, any new studies submitted for the purposes of plant protection product regulation should be conducted using these alternatives.  This requirement is in addition to considerations under animal welfare legislation (Directive 2010/63/EU - see Footnote). 

The Regulation applied from 14 June 2011 and sets out  a number of requirements aimed at avoiding unnecessary testing on vertebrate animals, including the avoidance of duplicate testing, and for the sharing of tests and studies involving vertebrate animals. In addition, the Regulation states in Article 62 (1) that:

'Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available'.

Currently validated in vitro alternatives are available that can replace in vivo skin and eye irritation studies.  For mixtures the calculation method can be used to replace in vivo studies for acute toxicity, skin and eye irritation and skin sensitisation when a reliable classification can be determined by this method. 

In the UK, the Plant Protection Products Regulation 2011 (Statutory Instrument 2011 No. 2131) is the enforcing regulation for Regulation (EC) No 1107/2009 and provides under regulation 15(1) that

(1)  A person must not undertake tests on vertebrate animals in contravention of the first sentence of Article 62(1), or cause or permit another person to do so.

And under regulation 23 that

A person who contravenes or fails to comply with –

(a) Any paragraph of regulations 9 to 13, 15 to 19, or 22;…… is guilty of an offence

The fact that a test may also be carried out for the purposes of an application or authorisation in another Non-EU regulatory body/authority which may have less stringent rules regarding testing on vertebrate animals does not invalidate the provisions of Article 62.

HSE will contact applicants where there is a concern that a breach of Article 62 (1) of the Regulation has occurred. 

What this means for applicants

HSE will contact applicants where there is a concern that a breach of Article 62 (1) of the Regulation has occurred.  This applies to vertebrate studies commissioned after 14 June 2011.

A. New applications submitted after the date of publication of this regulatory update

If any in vivo studies are submitted to HSE as part of an application for authorisation of a pesticide product or active substance, and the date of the study indicates it was commissioned after 14 June 2011 AND an acceptable alternative method (e.g. an adopted OECD Test Guideline for an in vitro alternative, or the calculation method) could reasonably have been used, then the application will be rejected.  HSE will also consider whether to conduct an investigation in relation to the potential breach of article 62(1) of the Regulation.

The applicant may resubmit the application using either the calculation method or acceptable in vitro studies. 

B. Interim procedure for applications already submitted prior to publication of this regulatory update, but not yet completed

Any in vivo studies already submitted to HSE as part of an application for authorisation of a pesticide product or active substance will not be evaluated if an accepted alternative method could reasonably have been used, and the date of the study indicates it was commissioned after 14 June 2011.  The applicant will be asked to provide an acceptable alternative method which may include an in vitro study or classification by calculation.  As for new applications, HSE will also consider whether to conduct an investigation in relation to a potential breach of Article 62(1) of the Regulation.

C. Procedure for products or active substances authorised/approved prior to publication of this regulatory update

Authorised products (or approved active substances) where in vivo studies were submitted to support that authorisation/approval when an appropriate alternative method was available at the time the study was commissioned will not have those authorisations or approvals revoked or re-evaluated. However, HSE will contact these authorisation holders to remind them of their obligations.

Further Information

Pesticides:  See the pesticide Applicant Guide on the HSE pesticides website for further information on vertebrate studies submitted under Regulation (EC) No. 1107/2009 for plant protection products.

Link to the Pesticide Applicant Guide

Biocides:  Please note that this Regulatory Update applies only to pesticides. When considering conducting vertebrate studies to support an application under Regulation (EU) No. 528/2012, please consult the HSE biocides website.

Link to Biocides website

Contact Information

If you have any questions relating to this Regulatory Update, please contact us.

Link to Contact details page

Footnote

Directive 2010/63/EU on the protection of animals for scientific purposes which updates and replaces Directive 86/609/EEC.  

 


Two Day Consumer Risk Assessment Workshop

As previously advertised, HSE's Chemicals Regulation Division (CRD) will be holding a two-day Consumer Risk Assessment workshop on Tuesday 14th and Wednesday 15th March, 2017 in York.  The aim of the event will be to raise awareness and provide guidance in the appropriate use of residue values in risk assessment models, and to highlight commonly encountered problems and topical issues in the field of residues evaluation and consumer risk assessment. The cost per delegate to attend the workshop will be £595.00 (plus VAT).

The event is targeted at technical and regulatory staff involved in the production and submission of residues data to HSE (CRD), and those performing consumer risk assessments to support authorisations.

Registrations

If you wish to register for the workshop please visit http://www.hsl.gov.uk/crd for further details, and complete an online registration form. The closing date for applications is 13th February 2017.            


Workshop on the Physicochemical Properties and Storage Stability Requirements for Pesticide Products under Regulation EC 1107/2009

As previously advertised, CRD will be running a one day workshop aimed at providing training on data requirements for the EU approval of active substances and plant protection products regarding the identity, the physicochemical properties and methods of analysis under Regulation EC 1107/2009.

The workshop will be held at the Chemicals Regulation Division in York on Thursday 23rd March 2017.  

If you wish to register for the workshop please visit http://www.hsl.gov.uk/crd for further details, and complete an online registration form.  The closing date for applications is 21st February 2017


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