Documents considered by the Committee on 8th December 2010 - European Scrutiny Committee Contents

14 Marketing and use of biocidal products



+ ADDs 1-2

COM(09) 267

Draft Regulation concerning the placing on the market and use of biocidal products

Legal baseArticle 95 EC; co-decision; QMV
DepartmentWork and Pensions
Basis of considerationMinister's letters of 13 October 2010 and 2 December 2010
Previous Committee ReportHC 19-xxiv (2008-09), chapter 4 (15 July 2009)
To be discussed in Council20 December 2010
Committee's assessmentPolitically important
Committee's decisionCleared


14.1 Biocidal products are used to destroy harmful organisms, and their marketing within the EU is regulated under Directive 98/8/EC.[67] This involves a two-stage process — the so-called "active substances", which give biocidal products their properties, being approved by the EU (and listed in an Annex to the Directive), whilst the authorisation of the products themselves is in the hands of Member States, with provision being made for a product approved in one Member State to be used in another. The Directive contains a simplified procedure for approving low-risk products, as well as provisions governing the use (and confidentiality) of data supplied in support of an application for approval, and rules relating to the classification, packaging, labelling and advertisement of products.

14.2 The Directive also provides that active substances on the market when it came into force should be reviewed to ensure they can still be used, and individual products containing them would then have to be authorised. This review programme was originally expected to last 10 years, and the Directive therefore contained a transitional period (until 14 May 2010) during which Member States could continue to apply their national rules for authorising these products. However, as progress turned out to be slower than anticipated, the transitional period was extended by three years.

14.3 In the meantime, the Commission put forward in June 2009 this proposal to replace Directive 98/8/EC by a Regulation, and to take into account a number of criticisms of the present arrangements. More specifically, as our predecessors noted in their Report of 15 July 2009, it suggested changes which would extend the scope of the measure to imported products; strengthen the mutual recognition of products authorised by a Member State; introduce a centralised EU authorisation system; strengthen the provisions relating to data sharing; enable the need for certain data to be waived where this is not scientifically necessary; and enable the Commission to establish rules for a harmonised fee structure.

14.4 The then Government said that it fully supported the regulation of biocidal products at a European level, and that there were no major policy issues which would give it grounds to oppose outright the introduction of this Regulation, which it described as urgently needed in the light of the very slow progress made so far in the 10 year programme envisaged in Directive 98/8/EC for reviewing existing active substances. It also observed that UK stakeholders, and particularly SMEs, had been heavily critical of the current Directive, and had argued that its requirements are both onerously expensive and overly complicated and disproportionate in relation to the overall benefits. In particular, the costs of supporting an active substance through the assessment process are high, due to the need to provide data and the fees levied by some Member States for assessing this. The then Government also provided an initial Impact Assessment, which formed the basis of its consultation with UK stakeholders, and which it said would be updated in the light of the responses received.

14.5 In noting the UK's support for the regulation of biocidal products at a European level, our predecessors also said that, since the then Government intended to produce a further assessment of the costs and benefits, they would draw the proposal to the attention of the House, but await that assessment before considering it further.

Minister's letter of 13 October 2010

14.6 We received from the current Minister for Employment at the Department for Work and Pensions (Rt Hon Chris Grayling) a letter of 13 October 2010 providing an update on the negotiations. He said that the Belgian Presidency was aiming to achieve political agreement in December, and that he would write to us again prior to that, when he would request scrutiny clearance.

14.7 In the meantime, the Minister said that the UK had put forward numerous drafting suggestions, many of which had been incorporated into the latest draft text, its focus having been on the need to streamline the authorisation process, without compromising protection of human health and the environment. He added that, although the overall picture was somewhat mixed, with some Member States favouring tighter controls, the direction of negotiations has been broadly positive so far as the UK's more pragmatic, risk-based approach was concerned. He also noted that the European Parliament had shown a high level of interest, with the plenary session having voted on a package of amendments, and he identified the positive outcomes for the UK as including the fact that (with a few exceptions) all biocidal product types would be open to EU-wide authorisation after an initial transitional period lasting until 2017; support for reduced testing on vertebrate animals and the waiving of data requirements; and the defeat of an amendment to increase the number of substances which are considered candidates for substitution (which had the potential to further restrict the biocidal substances allowed on the market).

14.8 However, he observed that there had also been some less positive outcomes, including the inclusion of some potentially burdensome additional administrative requirements, and some restrictive provisions on the use of nanomaterials in biocidal products. He summed up the overall position by suggesting that the picture for UK was mixed, though with more positives than negatives on the most important issues, and he noted that there had also been signs of a convergence of views on several of the main issues, leaving open the possibility of an agreement between the Council and Parliament in the first half of 2011.

14.9 The Minister also attached to his letter a full UK Impact Assessment, which identified savings from improved product authorisation procedures and from provisions for data-sharing and data-waiving, though with some increased costs as a result of an increase in scope to cover treated articles and materials. Overall, the assessment estimated that the Regulation proposed would lead to an overall cost saving of between £135m and £264m for UK industry over 10 years, but that these could potentially be greater if UK was able to secure further streamlining and simplification to the regime through drafting changes.

Minister's letter of 2 December 2010

14.10 We have now received from the Minister a further letter of 2 December 2010, providing an update on the negotiations. He says that the indications are that Member States are now converging on an agreed text, on which the UK remains relatively well placed in most respects. In particular, he says that there is a consensus that active substances with certain health and environmental hazards should be excluded from use in biocides, but that, in recognition that inherently hazardous substances may be required for beneficial purposes, derogations would be allowed where the exclusion of a substance would have a disproportionately negative impact and no suitable alternatives are available; that the UK favours giving a wide scope to the EU-wide authorisation of certain products to maximise the cost savings for businesses which market biocides across the EU, and has resisted pressure from some other Member States to narrow this provision; and that an agreed position is now close on provisions for data-sharing and data-waiving and the mutual recognition of authorisations.

14.11 The Minister concludes by asking us to release the document from scrutiny in advance of the meeting of the Environment Council on 20 December, when he says the Presidency is hoping to achieve a common position.


14.12 We are grateful to the Minister for this information, and, in the light of the progress in the negotiations and the positive overall cost-benefit position revealed by the full UK Impact Assessment, we are now content to clear the document.

67   OJ No. L 123, 24.4.98, p.1. Back

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Prepared 24 December 2010