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Documents considered by the Committee on 6 February 2019 Contents

7Commission Brexit preparedness: Biocidal products

Committee’s assessment

Politically important

Committee’s decision

Not cleared from scrutiny; further information requested; drawn to the attention of the Business, Energy and Industrial Strategy Committee

Document details

Commission delegated Regulation (EU) .../... of 28.11.2018 amending delegated Regulation (EU) No 1062/2014 as regards certain active substances for which the competent authority of the United Kingdom has been designated as the evaluating competent authority

Legal base

Article 89(1) and 83 of Regulation (EU) No 528/2012 (the Biocidal Products Regulation);—

Department

Health and Safety Executive

Document Number

(40242), 14911/18 + ADD 1, COM(18) 7778

Summary and Committee’s conclusions

7.1The proposal under scrutiny concerns the amendment of Regulation (EU) No 1062/2004 (the Review Regulation). The Review Regulation gives effect to the Union’s rolling programme of re-evaluation for biocidal active substances placed on the market before May 2000 (when the approval of active substances and the authorisation of biocidal products was governed by the EU’s predecessor framework).48

7.2The Commission is proposing to amend the Review Regulation in light of the UK’s withdrawal from the EU. At present, the Health and Safety Executive—as the UK competent authority—is charged with evaluating a number of substances on behalf of the Union. In accordance with Union law, evaluation and, respectively, the approval and authorisation of active biocidal substances and products, can only be undertaken by an EU Member State, EEA member or Switzerland. These processes are governed by Regulation (EU) No 528/2012 (the Biocidal Products Regulation).

7.3As an ‘exiting’ Member State, the Commission argues that such changes must be made irrespective of whether the proposed transition/implementation period under the draft Withdrawal Agreement goes ahead (and thus covers the possibility of a ‘no-deal’ or non-negotiated exit). This is in line with Article 128(6) of the draft Withdrawal Agreement which provides that “the United Kingdom shall not act as leading authority for risk assessments, examinations, approvals or authorisations at the level of the Union…”. During the proposed transitionary period the UK would, however, be required—as per Article 127 of the draft Withdrawal Agreement—to recognise Union-issued approvals and authorisations. In accordance with the provisions of Chapter VII of the Biocidal Products Regulation (on mutual recognition procedures), the UK would also—subject to the grounds for derogation provided for in Article 37 of the Regulation—continue to be bound by the requirement to recognise an authorisation granted by the competent authority of (another) Member State.

7.4In terms of the UK’s role in EU approvals during the transitionary period, Article 127 of the draft Withdrawal Agreement states that the UK:

[May] not act as a leading authority for… approvals or authorisations at the level of the Union or at the level of Member States acting jointly as referred to in the acts and provisions listed in Annex VII” (author’s own emphasis added).49

7.5It appears that the term ‘leading authority’ refers to the process of mutual recognition set under the Biocidal Products Regulation (the BPR) whereby a Member State acts as a ‘reference’ or lead Member State when an application is made for the approval of a biocidal product to more than one Member State at the same time (known under Article 34 of the BPR as ‘mutual recognition in parallel’). This reference Member State is charged with tasks such as informing the applicant of any fees due, validating an applicant’s submission and producing a draft assessment report.

7.6It is unclear whether the phrase ‘acting jointly’—as per Article 127—precludes a UK-issued approval from being used as the basis for an approval sought in (another) Member State (known as ‘mutual recognition in sequence’). This question appears to turn on how the phrase ‘acting jointly’ is understood. It could be understood as: (1) referring to a situation whereby Member States collaborate on the initial process of national approval—through, for example, the exchange of expertise or information—with the lead Member State making a final decision or, alternatively; (2) implying a far looser relationship whereby Member States are said to be acting together when considering one another’s decisions. Either way, it appears highly unlikely that the Commission would exclude one form of mutual recognition—that in parallel—and retain another when both provide for the same outcome via only slightly different routes.

7.7With regards to the potential implications of the proposed transitionary period for business operators, according to the BPR (which will continue to apply in the UK in accordance with Article 127 of the draft Withdrawal Agreement), holders of product authorisations must be established in the EU (or EEA or Switzerland) and, for active substance or product suppliers included in the list referred to in Article 95 of the Regulation (the ‘active substance list’), be established or have a representative established in the EU, EEA or Switzerland.

7.8As, for the purposes of Union law, the UK would continue to be considered a Member State during transition (subject to the exemptions provided for in Article 127(6) of the draft Withdrawal Agreement), UK-based companies who hold an authorisation from an EU-27 Member State would not, in order to retain that authorisation, have to arrange for its transfer to a new holder established in either the EU, EEA or Switzerland. For active substances originally evaluated by the HSE and subsequently approved by another Member State or at Union-level, such approvals would remain valid irrespective of whether the draft Withdrawal Agreement is ratified; this is as validity is said to derive from the approving Member State or the Union not the original evaluating Member State.

7.9As approval holders for an active substance are not considered under Union law to be ‘owners’ or ‘holders’ of approvals (in the same way in which companies who hold authorisations are), they do not need to be established in the EU. For active substance or product suppliers included on the active substances list (as per Article 95 of the BPR), there would be no immediate requirement to re-establish or have a representative established in either the EU, EEA or Switzerland.

7.10In the context of the UK’s future relationship with the EU, the draft EU-UK political declaration contains the commitment that:

The Parties [the UK and EU] will also explore the possibility of cooperation of United Kingdom authorities with Union agencies such as… the European Chemicals Agency (ECHA).

7.11At present, there is little information available on what future cooperation with the ECHA could look like but it would almost certainly include, at minimum, access to the R4BP 3 database—used for biocide evaluations and applications—and the participation of UK experts in the Biocidal Products Committee. Deeper integration with the ECHA—such as associate membership—would likely entail continued alignment with EU rules. Given the current restrictions surrounding ‘third country’ (non-Member State) participation in biocide approvals and authorisations—which is significantly restricted—it is highly unlikely that anything other than an agreement on information exchange and some form of participation in expert committees could be achieved. This is not to say, however, that such participation would not be valuable (especially in light of the resource implications implicit in operating a domestic approvals and authorisations framework similar to that of the Unions).

7.12In terms of its content, the Commission’s proposal is not controversial and relates solely to the Union’s internal preparations for the UK’s withdrawal from the EU. The Commission is proposing to transfer each active substance/product-type for which the HSE is currently the evaluating authority to competent authorities in EU Member States and EEA/EFTA members. Additional changes are also suggested to set new deadlines by which evaluations must be completed. Provision would also be made to allow competent authorities to charge fees for these evaluations. As per Annex II to the Review Regulation, the HSE is currently responsible for the evaluation of 57 substances/product types (this equates to roughly 1/8th of the EU total).

7.13The Union’s internal preparations provide an opportunity to assess the Commission’s and the Government’s plans for how the authorisation and approval of biocidal active substances and products would function in the event of a no-deal Brexit (where the draft Withdrawal Agreement is not ratified by either the UK or the EU).

No-deal preparations

The Commission

7.14The Commission’s no-deal preparations centre around the status of approvals and authorisations granted prior to 29 March 2019 (as the UK cannot act as a ‘lead authority’ for approvals and authorisations during the transitionary period).50

7.15The Commission—in its no-deal notices—and the European Chemicals Agency have made a number of suggestions to UK-based holders and businesses in this regard. These follow-on, mainly, from the preceding discussions and include the advice that:

7.16The Commission has also warned businesses to carefully consider existing timelines for the evaluation and approval of biocides for which the UK is the evaluating or reference Member State and to closely monitor the progress of ongoing procedures.

7.17As per Article 44 of the draft Withdrawal Agreement, the UK will have to transfer all files and documents relating to assessments, approvals and authorisations for which it is acting as the competent authority to that of another Member State before the date the agreement enters into force.

7.18The Withdrawal Agreement is, however, not explicit as to whether this requirement relates to substances that the UK has been charged with re-evaluating under the Review Regulation or extends to cover authorisations that the HSE is processing in accordance with either of the mutual recognition process provided for under the Biocidal Products Regulation (those undertaken in parallel or in sequence). This is as Article 44 of the draft Withdrawal Agreement reads:

The United Kingdom shall transfer without delay to the competent authority of a Member State designated in accordance with the procedures provided for in the applicable Union law all relevant files or documents…

7.19Reference in Article 44 to ‘designated’ Member States and of transfers being made in accordance with ‘applicable Union law’ appears to cover the changes under scrutiny (i.e. those to the Review Regulation to reallocate substances by way of delegated act that the UK is currently charged with reviewing). It is not altogether certain as to whether the same can be said of the BPR; this is as, to date, proposals have not been forthcoming to allocate Member States with existing UK evaluations or approvals. Given that this process is more business-driven,51 it could be that the Commission will come forwards with a technical—rather than legal—solution to such transfers and allow companies to choose any EU-27 competent authority or reference Member State to continue with their application (this would be in keeping with current ECHA advice).

HM Government

7.20The Minister of State for Disabled People, Health and Work (Sarah Newton MP), wrote to the Committee on 19 December 2018 by way of explanatory memorandum. The Minister explains the background to the Commission’s proposal and provides information on the Government’s plans for regulating biocides in the event of a no-deal Brexit.

7.21Regarding the future of the Review Regulation—and the roughly 500 active substances that the HSE will have to evaluate in the event of a no-deal Brexit—the Minister states that the Government would “put in place an alternative programme for reviewing remaining [active] substances…”. The resource implications of operating such a programme are said to have been considered, however, the Minister does not provide the details for any such assessment.

7.22Rather surprisingly, the Minister states that the Government will not “determine the scope of any [domestic] review programme” but will re-evaluate those substances earmarked for review by the ECHA when requested to do so by businesses. This marks a move away from what can be described as the ‘systematic’ approach of the Union to one that appears to be more ‘ad-hoc’ in nature.

7.23The Minister also informs the Committee that a statutory instrument would be laid under the European (Withdrawal) Act 2018 (EUWA) to amend the Biological Products Regulation:

[To] give the Secretary of State the power to make regulations… to extend the date for the systematic examination of existing active substances and specify matters in relation to carrying out a UK work programme.

It appears from the Minister’s statement that the HSE would continue with the re-evaluation of the 57 active substances currently under its charge, however, this is not clear. The Minister’s desire to extend the date by which examinations must be undertaken—in accordance with the Review Regulation—is also noteworthy. No further information is provided on specific dates.

7.24On the Government’s broader plans for the approval and authorisation of biocides in the event of a no-deal Brexit, it published a notice to stakeholders in December 2018. The Government’s notice states that the UK would retain the EU’s framework—as currently provided for in domestic legislation—with small changes made where necessary to ensure that it functions correctly (this would be achieved by way of statutory instrument made under the EUWA).

7.25The HSE would take on all functions currently performed by the ECHA and, as a consequence, would be charged with all evaluations, technical equivalence assessments, approvals and authorisations etc. The Government states its desire for these processes to remain closely aligned to those in place under the current EU framework so as to minimise disruption to business. Plans are also said to be in place to launch a UK version of the EU’s Article 95 active substances list and to create a database similar to the EU’s R4BP 3 information portal.

7.26In terms of the validity of UK-issued approvals, the Government’s position is less maximalist than the EU’s no-deal framework. Product authorisations would remain valid until their normal expiration date, however, subject to transitionary arrangements, authorisation holders would need to be established in the UK. The same location requirement would be introduced for active substance suppliers. The Government intends to ‘copy-over’ companies included on the EU’s Article 95 list to a new UK equivalent (and would provide extra time—versus the Union’s proposals—for companies to supply any additional information required).

7.27The Government’s no-deal preparations also cover the status of ongoing applications. Where possible, applications made directly to the HSE would be considered under the UK’s new system. For those made as part of a wider EU process—such as via mutual recognition—a new application would have to be made. As is to be expected, the Government’s no-deal notice does not outline whether the Union would, in such circumstances, make relevant information available to the UK.

7.28We thank the Minister for her Explanatory Memorandum of 19 December 2018. We would also like to thank officials at the Health & Safety Executive for the promptness with which they consulted the Committee on the need to deposit the proposal under scrutiny.

7.29We retain the proposal under scrutiny pending satisfactory answers to the questions—and requests for further information—raised below. Given that the UK is scheduled to leave the EU in less the 9 weeks, we request a full response to our enquiries by 20 February 2019. In light of the Brexit-related implications the proposal raises, we draw it to the attention of the Business, Energy and Industrial Strategy Committee.

7.30With regards to the substance of the proposal and, in particular, the Government’s plans for the future operation of the Review Regulation, we seek clarification of whether the HSE will continue with the re-evaluation of the 57 active substances for which it is currently responsible.

7.31The Committee understands that with the entry into force of the Review Regulation, the HSE was transferred funds by the ECHA for the re-evaluation of these 57 substances. If this is true, we request information on the amounts received by the HSE—per substance and in total—and whether these amounts will have to repaid and, if so, by when.

7.32In her explanatory memorandum of 19 December 2018, the Minister of State for Disabled People, Health and Work (Sarah Newton MP), states that the “resources implications of operating a UK-specific review programme in the case of a no-deal exit have also been considered by the HSE”. The Committee requests a full summary of the assessment on which this statement is made.

7.33With regards to the approval and authorisation of biocidal substances and products during the proposed transitionary/implementation period, we seek the Government’s understanding of:

7.34The Committee would also like to hear about the Government’s plans for articles treated with biocidal products after EU exit, in particular, whether articles treated with biocides will only be allowed into the UK if they contain active substances that have been approved by the HSE.

7.35In terms of the UK’s future relationship with the EU, we seek information on whether there would be any practical impediments to the participation of UK experts in the EU Biocidal Products Committee and involvement in the operation—and use of—the Union’s R4BP 3 database (such impediments could include limitations imposed on third countries who are associate members of the ECHA).

Full details of the documents

Commission delegated Regulation (EU) .../... of 28.11.2018 amending delegated Regulation (EU) No 1062/2014 as regards certain active substances for which the competent authority of the United Kingdom has been designated as the evaluating competent authority: (40242), 14911/18 +ADD 1, COM(18) 7778.

Background

Biocidal products/biocides

7.36Biocidal products—or biocides—are chemical substances or microorganisms that are intended to destroy, deter, render harmless or exert a controlling effect over any harmful organism by chemical or biological means (the non-active element of a biocidal product is usually a co-formulant designed to regulate considerations such as pH, viscosity, colour or odour).

7.37The terms ‘biocides’ and ‘pesticides’ are often used interchangeably. Whereas pesticides include both biocides and plant protection products (designed to protect crops or desirable or useful plants), biocides are commonly used in isolation for non-food and feed purposes. In industry, biocidal products are employed to control organisms such as viruses, bacteria, fungi and vermin. Similar uses are made of biocidal products by members of the general public.

Biocidal Products Regulation/Review Regulation

7.38At EU-level, the Biocidal Products Regulation (Regulation (EU) No 528/2012) governs the evaluation and approval of biocidal products—and biocidal active substances—before they can be placed on the market (sold). There are, however, certain exemptions to this framework. As an example, some biocidal products containing active substances covered by the Union’s ‘review programme’ can be made available on the market and used—subject to national laws—pending a final decision on approval (and for up to 3 years afterwards).

7.39The BPR also sets rules for articles treated with—or intentionally incorporating—biocidal products. In accordance with the Regulation, articles can only be treated with biocidal products containing active substances that have been approved in the EU. In practice, this prevents the importation of articles from third countries that have been treated with active substances that are not recognised by the ECHA (e.g. soft furnishings from the USA that have been coated with Dimethylformamide (DMF) (a solvent used in the production of textiles)).

7.40The Union’s review programme is given effect to by Regulation (EU) No 1062/2014 (the Review Regulation). The Review Regulation provides for the re-evaluation of all active substances used in biocidal products placed on the market before May 2000 (the point at which national legislation ceased to govern the evaluation and approval of biocidal products). Annex II to the Regulation sets the UK as the evaluating state responsible for a number of substances on behalf of the Union. These substances include, for example, Calcium oxide, three different lime compounds and Ammonium sulphate.

The EU evaluation and approval process

7.41All biocidal products—and the active substances they contain—require authorisation before they can be placed on the market (for active substances, this process is known as approval). Under the Biological Products Regulation (the BPR), active substances must be approved before a product containing such a substance can be authorised (and cleared to be placed on the market). A decision on approval is adopted by the Commission based upon an opinion prepared by the Biocidal Products Committee (working under the auspices of the European Chemicals Agency (ECHA)).

7.42There are two main routes to product authorisation. First, if a product is to be placed only on the market of a single Member State, national authorisation from the relevant competent authority is sufficient (in the UK, the Health and Safety Executive (HSE) is the competent authority for product authorisations). If a company wishes to extend a national authorisation to other markets, it can apply for mutual recognition. This can be done either in sequence (to one Member State after another) or in parallel (to more than one competent authority at a time). Second, the BPR introduced the possibility for certain biocidal products to be authorised at EU-level; allowing companies to place products on markets throughout the Union without the need to obtain separate national authorisations and/or decisions on recognition.

7.43Under the Regulation, certain conditions on approvals and authorisations—linked to the location of the company seeking recognition—must be met. Holders of product authorisations must be established in the EU (or the EEA or Switzerland). For active substances, substance or product suppliers included in the list referred to in Article 95 of the Regulation—the ‘active substance list’—must be established or have a representative established in the EU, the EEA or Switzerland.

7.44Another important part of the Regulation is the common obligation for existing data owners and prospective applicants for approvals and authorisations to share certain data from tests and studies. By doing this, applicants can reduce costs and the need to conduction tests involving vertebrate animals. This process—as with that for substance approvals and Union-wide product authorisations—is administered through R4BP 3 (the Union’s central hub through which all biocide applications are made). As a Member State, UK officials participate in technical seminars designed to identify necessary changes to R4BP 3 (UK experts are also involved in the activities of the Biocidal Products Committee).

7.45The ECHA levies fees for the approval of active substances and the issuance of Union-wide authorisations. These range from €120,000 for a first product-type approval of an active substance to between €1,500–€20,000 for renewals (fees for Union-wide authorisations are similar). Although not directly comparable, the HSE estimates a charge of roughly £10,000 for authorising a new biocidal product. Under the Union’s review programme, funds have been transferred to competent authorities for the evaluation of active substances—for which they hold responsibility—placed on the market before May 2000.

Previous Committee Reports

None.

48 The background section of this chapter provides a brief explanation of what biocidal products/biocides are and how the evaluation and approval process for such substances/products operates.

49 The BPR is listed in Annex VII to the draft Withdrawal Agreement.

50 As per Article 128(6) of the draft Withdrawal Agreement (and discussed above at subparagraph 3).

51 N.B. Member States are not designated for evaluation and approvals by Union law rather they are chosen by businesses based upon factors such as the market into which they wish to supply a product.



Published: 12 February 2019