Bezwaar­motie over de ontwer­puit­voe­rings­ver­or­dening van de Commissie tot verlenging van de goed­keuring van propi­co­nazool als werkzame stof voor gebruik in biociden van product­soort 8 over­een­komstig Veror­dening (EU) nr. 528/2012

Draft motion for a resolution

pursuant to Rule 112(2) and (3) of the Rules of Procedure

on the draft Commission implementing regulation renewing the approval of propiconazole as an active substance for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Committee on the Environment, Public Health and Food Safety

Members responsible: Maria Arena, Jutta Paulus, Anja Hazekamp

B9‑0000/2023

European Parliament resolution on the draft Commission implementing regulation renewing the approval of propiconazole as an active substance for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(D092065/01 – 2023/2897(RSP))

The European Parliament,

– having regard to the draft Commission implementing regulation renewing the approval of propiconazole as an active substance for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (D092065/01),

– having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products[1], and in particular Article 14(4), first subparagraph, point (a), thereof,

– having regard to the opinion adopted on 9 March 2022 by the Biocidal Products Committee of the European Chemicals Agency[2],

– having regard to Article 11 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers[3],

– having regard to Rule 112(2) and (3) of its Rules of Procedure,

– having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

A. whereas the draft Commission implementing regulation proposes to renew the approval of propiconazole as an active substance for use in biocidal products of product-type 8 for a period of seven years;

B. whereas, in its communication of 14 October 2020 entitled ‘Chemical Strategy for Sustainability - Towards a Toxic-Free Environment’, the Commission has committed to a zero-pollution ambition to attain a toxic-free environment to help to protect citizens and the environment better against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives;

C. whereas propiconazole as an active substance is widely used in biocidal products of product-type 8, as around 60 % of the total number of products of that product-type which are authorised contain propiconazole[4];

Toxic for reproduction and endocrine-disrupting properties

D. whereas propiconazole is classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council[5], and therefore meets the exclusion criterion set out in Article 5(1), point (c), of Regulation (EU) No 528/2012; whereas, according to the opinion of 22 March 2022 of the Biocidal Products Committee, propiconazole is considered as having endocrine-disrupting properties that may cause adverse effects in humans, and therefore meets the exclusion criterion set out in Article 5(1), point (d), of Regulation (EU) No 528/2012;

E. whereas propiconazole is a candidate for substitution in accordance with Article 10(1), points (a), (d) and (e), of Regulation (EU) No 528/2012;

F. whereas the Biocidal Products Committee concluded that there are no unacceptable risks to human health and the environment from the use of biocidal products containing propiconazole, but only ‘when leaving aside the endocrine disrupting properties of propiconazole, and when risk mitigation measures are applied to limit the exposure of humans, animals and the environment to propiconazole as far as possible’; whereas the Biocidal Products Committee further found that no conclusion could be drawn on the level of risks of using propiconazole to human health (for the industrial and professional user, or for the general public) and the environment, considering its endocrine disrupting properties;

G. whereas the Biocidal Products Committee concluded, based on a representative formulation, that it had not been demonstrated by the applicant that biocidal products containing propiconazole for product-type 8 may be expected not to have unacceptable effects itself, or as a result of its residues, on human health and on the environment, and that it may be expected to satisfy the criteria set out in Article 19(1), points (b)(iii) and (b)(iv), of Regulation (EU) No 528/2012;

H. whereas proposing to renew a substance classified as toxic for reproduction category 1B, and failing to take into account the endocrine-disrupting properties of propiconazole in its evaluation is a manifest failure by the Commission to uphold its duty of ensuring a high level of protection of both human health and the environment; whereas unacceptable risks to human health and the environment would therefore result from the use of biocidal products containing propiconazole;

Consideration of available alternatives

I. whereas, pursuant to Article 12(1) of Regulation (EU) No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed if the active substance still meets the conditions laid down in Article 4(1) of that Regulation or, where applicable, at least one of the conditions set out in Article 5(2) of that Regulation;

J. whereas, based on the information collected and the views expressed by Member States, the Commission concluded that propiconazole meets the condition set out in Article 5(2), point (c), of Regulation (EU) No 528/2012 as the Commission considered that not approving the active substance propiconazole would have a disproportionate negative impact on society when compared with the risk to human health and the environment arising from the use of this substance, in particular because of the lack of alternatives for the proposed uses;

K. whereas, in its opinion of 22 March 2022, the Biocidal Products Committee concluded that alternative active substances are available for at least some uses but their technical feasibility and the availability of products in different Member States have not been analysed in detail, and that non-chemical alternatives are also available for some uses but cannot substitute all uses of wood treated with propiconazole;

L. whereas, for the use of propiconazole for Use Classes (UC) 2 and 3, the Biocidal Products Committee found that alternative methods such as heat treatment of wood and to a less extent chemical modification such as acetylation and furfurylation are used to produce wood for UC 2 and UC 3 and that those methods can be used at least for some forms of timber construction materials that propiconazole is currently used to treat;

M. whereas biocidal products based on penflufen as an active substance have been identified by the Biocidal Products Committee as a potential alternative to propiconazole for UC 3 in prolonged wetting conditions and UC 4 (industrial treatment of structural wood) at least in oil-based products, for UC 2 and 3 in limited wetting conditions (professional treatment of joinery), and for brush or spraying applications by professional users when used in combination with IPBC; where the Biocidal Products Committee concluded that for those alternative biocidal products, more time is needed to test and have a sufficient return on experience;

Appropriateness of risk mitigation measures

N. whereas the draft Commission implementing regulation provides for specific risk mitigation measures for the placing on the market of biocidal products containing propiconazole as an active substance and of treated articles;

O. whereas, in her decision in case 12/2013/MDC of 18 February 2016 on the practices of the European Commission regarding the authorisation and placing on the market of plant protection products (pesticides), the European Ombudsman called on the Commission to review its approach to the definition and implementation of mitigation measures (conditions and restrictions), so as to include further requirements aimed at ensuring that the Commission does not evade its responsibility to ensure the effective protection of human health, animal health and the environment by allowing Member States almost absolute discretion as regards the definition of mitigation measures for potentially unsafe substances, given that standard formulations are very open-ended and it can be doubted whether they can be legally described as requiring mitigation measures at all;

P. whereas, as the draft Commission implementing regulation currently stands, biocidal products containing propiconazole will only require labels or, where provided, safety data sheets, to be placed on the market and such labels or data sheets will not be subject to regulatory scrutiny before the product is placed on the market; whereas there will also be no evaluation of whether efficacy of such products matches the label claim; whereas those risk mitigation measures cannot be considered to be of a binding nature or sufficient to ensure a high level of protection of human health and the environment, considering that no conclusion on the risk derived from endocrine-disrupting properties could be established;

Trade of treated articles

Q. whereas, while the authorisation of products to treat articles will be restricted for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is met, it will still be possible to freely import or trade treated articles between any Member States, even those that do not consider the conditions of Article 5(2) as being met;

R. whereas, under the draft Commission implementing regulation, only a label phrase providing the limited information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012 and a warning statement will be required on treated articles and that information and statement will not be subject to regulatory scrutiny before the article is placed on the market; whereas, since no product authorisation is necessary, there will also be no evaluation of whether efficacy of such articles matches the label claim;

S. whereas, therefore, the draft Commission implementing regulation does not provide a high enough level of protection of human health and the environment, and does not provide a level playing field for Union and non-Union companies;

T. whereas the Commission should have protected the Union’s citizens and the environment on the basis of scientific information, using the obligation and the legal possibilities that Regulation (EC) No 528/2012 provides for, to ensure a high level of protection of both human health and the environment; whereas this should have led to the non-renewal of propiconazole as an existing active substance for use in biocidal products of product-type 8;

U. whereas the renewal of the approval of propiconazole is therefore inappropriate, demonstrates non-observance of the precautionary principle, and constitutes a violation of the legal obligation on the Commission to ensure a high level of protection of both human health and the environment.

1. Considers that the draft Commission implementing regulation exceeds the implementing powers provided for in Regulation (EU) No 528/2012,

2. Considers that the draft Commission implementing regulation is not consistent with Union law, in that it is not compatible with the aim and content of Regulation (EU) No 528/2012;

3. Considers that the draft Commission implementing regulation renewing the approval of propiconazole for a period of seven years is not proportionate in light of the unacceptable risks propiconazole poses to human health and the environment, in view of

(a) the classification of propiconazole as toxic for reproduction category 1B and its endocrine-disrupting properties,

(b) the availability of alternatives for some of the uses proposed for approval,

(c) the inappropriateness of the risk mitigation measures and their non-binding character in view of the fact that no conclusion could be drawn on the level of risks to human health and the environment from using propiconazole, considering its endocrine-disrupting properties, and the lack of protection regarding the trade of treated articles on the internal market;

4. Calls on the Commission to withdraw its draft implementing regulation and to submit a new draft to the committee, proposing a non-renewal of the approval of propiconazole, as granting a renewal of the approval of propiconazole, despite its hazardous properties and the lack of adequate risk mitigation measures, would not be compatible with the aim and content of Regulation (EU) No 528/2012;

5. Calls on the Commission, without prejudice to paragraph 4,

(a) not to renew the approval of propiconazole for uses for which alternatives have been identified;

(b) not to renew the approval of propiconazole for longer than is necessary to assess the effectiveness for uses for which alternative biocidal products based on penflufen as an active substance have been identified as a potential alternative to propiconazole;

6. Reiterates that renewing the approval of a substance classified as toxic for reproduction category 1B and which has endocrine-disrupting properties poses unacceptable risks to human health in relation to uses such as those proposed for renewal in the draft implementing regulation;

7. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

[1] OJ L 167, 27.6.2012, p. 1.

[2] Biocidal Products Committee opinion of 9 March 2022 on the application for approval of the active substance: Propiconazole, Product type: 8, ECHA/BPC/324/2022, https://echa.europa.eu/documents/10162/63dfef83-f970-64bf-1896-b74934fff276

[3] OJ L 55, 28.2.2011, p. 13.

[4] Biocidal Products Committee opinion of 9 March 2022.

[5] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353 31.12.2008, p. 1).