European Parliament resolution of 13 December 2022 on the draft Commission implementing regulation granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (D084293/01 — 2022/2929(RSP))
Date: 2022-12-13
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: biocide, chemical product, crude oil, dangerous substance, environmental protection, market approval, motor fuel, pollution control measures, preservative, public health








C_2023177EN.01000901.xml










17.5.2023   


EN


Official Journal of the European Union


C 177/9






P9_TA(2022)0434
The biocidal product family ‘CMIT/MIT SOLVENT BASED’
European Parliament resolution of 13 December 2022 on the draft Commission implementing regulation granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (D084293/01 — 2022/2929(RSP))
(2023/C 177/02)

The European Parliament,






—


having regard to the draft Commission implementing regulation granting a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (D084293/01,










—


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 44(5), first subparagraph, thereof,










—


having regard to the opinion delivered on 26 September 2022 by the Standing Committee on Biocidal Products,










—


having regard to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (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 provides that a Union authorisation with authorisation number EU-0023657-0000 is granted to Nutrition & Biosciences Netherlands B.V. for the making available on the market and use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ of product-type 6, as described in Annex V to Regulation (EU) No 528/2012, for preservation of de-watered crude oil and refined products (middle and light distillate fuels);










B.


whereas the Commission has committed to a zero-pollution ambition to attain a toxic-free environment to help protect citizens and the environment better against hazardous chemicals and to encouraging innovation for the development of safe and sustainable alternatives;










C.


whereas the Stockholm Convention on Persistent Organic Pollutants (4) (‘Stockholm Convention’) and the Aarhus Protocol on Persistent Organic Pollutants (5) have the objective of protecting human health and the environment from persistent organic pollutants (‘POPs’); whereas Regulation (EU) 2019/1021 was adopted to implement the Union’s obligation under that Convention and that Protocol;










D.


whereas the opinion of 5 March 2020 (6) of the Biocidal Products Committee (‘BPC’) of the European Chemicals Agency (‘ECHA’) included a minority opinion from Germany concluding that the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ as a preservative in fuels conflicts with the national legislation of that Member State (10th Federal Emission Control Ordinance § 2(1) and (2)), which prohibits fuels for on-road motor vehicles from containing additives with chlorine or bromine compounds, and prohibits the placing on the market of additives that contain chlorine or bromine, as those compounds cause the formation of dioxins during fuel combustion; whereas, in particular, that biocidal product family contains halogenated organic compounds (CMIT-MIT) which may result in the formation of dioxins during fuel combustion;










E.


whereas dioxins and furans (PCDD/PCDF) belong to the category of POPs, covered by the Stockholm Convention, and are included as substances subject to release reduction provisions in Annex III to Regulation (EU) 2019/1021; whereas human exposure to dioxins and dioxin-like substances has been associated with a range of toxic effects, including carcinogenicity, chloracne, reproductive, developmental and neurodevelopmental effects, immunotoxicity, and effects on thyroid hormones, liver and tooth development (7);










F.


whereas, in January 2019, the Union published its third implementation plan to address POPs (8); whereas, according to that implementation plan, ‘[r]eleases of unintentionally produced by-products listed in Annex C (dioxins, furans, PCBs, PeCB, HCB and from December 2016 PCNs) are subject to continuous minimisation with the ultimate objective of total elimination, where feasible’;










G.


whereas the Commission decided to address the concerns about dioxin formation by requesting an opinion from ECHA, under Article 75(1), second subparagraph, point (g), of Regulation (EU) No 528/2012, to estimate the amount of formation of dioxins and the overall contribution to the emissions of dioxins due to the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in fuels used for road and water transport, and to clarify the level of the risks to human health and the environment due to the exposure to dioxins via the environment from the use of that biocidal product family, so as to determine whether the risks can be considered acceptable or not;










H.


whereas in its mandate requesting the opinion from ECHA, the Commission underlines the need to clarify whether authorising that biocidal product family would be in line with the objectives set out in Regulation (EU) 2019/1021;










I.


whereas in its opinion of 5 July 2021 (9) on the request under Article 75(1), second subparagraph, point (g), ECHA concluded that, based on the current level of knowledge on the use of C(M)IT/MIT as a preservative in oil and fuel, it is not possible to draw any conclusions on the magnitude of the potential contribution of the use of C(M)IT/MIT in fuels with respect to dioxin emissions and exposure, or on the risks for human health and for the environment associated with the use of chlorine additives such as C(M)IT/MIT in fuels;










J.


whereas, despite ECHA’s conclusion, the Commission ‘considers that refusing the Union authorisation for the biocidal product family “CMIT/MIT SOLVENT BASED” would not lead to a significant decrease of dioxin emissions compared to granting it’ and therefore that this authorisation would be compliant with the Union’s obligations under the Stockholm Convention and Regulation (EU) 2019/1021;










K.


whereas the Commission’s reasoning is that, as a consequence of the ambitions of the European Green Deal (10) and Regulation (EU) 2021/1119 of the European Parliament and of the Council (11) to achieve climate neutrality by 2050, the overall amount of fuel that may potentially be treated with the biocidal product family and combusted in motors or heating systems is expected to decline significantly in the coming decades, which would in turn lead to the formation of dioxins associated with the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ decreasing accordingly;










L.


whereas, in its opinion of 5 July 2021, ECHA states that ‘there is no doubt from literature that motor vehicles powered with fuels containing chlorine are sources of dioxin and furan emission’ and that, contrary to the reasoning of the Commission mentioned in recital K, ‘although still minor compared to current dominant sources, the relative contribution of non-industrial diffuse sources [to dioxin and furan emissions], including transport, is […] likely to increase.’;










M.


whereas ECHA also states in its opinion of 5 July 2021 that ‘although emissions from traffic are minor compared to current dominant sources, it should be noted that their relative importance in terms of relative human exposure could be higher, due to their spatial distribution in densely populated urban areas, close to the human population and living environment and with less dilution of emissions.’;










N.


whereas the scientific uncertainty as to the level of the risks to human health and the environment due to the exposure to dioxins via the environment from the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ does not make it possible to reach a conclusion as to whether authorising that biocidal product family would be in line with the Stockholm Convention and Regulation (EU) 2019/1021;










O.


whereas Denmark and Belgium, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, made a request to the Commission for the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ not to apply in their respective territories, based on the grounds provided in Article 37(1), points (a) and (c), of that Regulation, as the presence of halogenated organic compounds, such as C(M)IT/MIT, in fuel may result in the formation of dioxins during fuel combustion; whereas Germany, in accordance with the same provision, made a request to the Commission to adjust the conditions of that authorisation in its territory based on the same grounds so as not to allow its use for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis;










P.


whereas the Commission considers that the requests made by Denmark, Belgium and Germany to be ‘justified on the grounds of the protection of the environment and the protection of health and life of humans pursuant to Article 37(1), points (a) and (c), of [Regulation (EU) No 528/2012] as the presence of halogenated organic compounds, such as C(M)IT/MIT, in fuel may result in the formation of dioxins during fuel combustion’;










Q.


whereas there is an apparent contradiction between the decision by the Commission to grant an authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’, considering that that authorisation is compatible with the objectives of the Stockholm Convention and Regulation (EU) 2019/1021, as laid down in recital 9 of the draft Commission implementing regulation, and not applying or adjusting that authorisation in certain Member States due to its potential negative effects on human health and the environment, stemming from dioxin formation as referred to in recitals 10 to 14 of the draft Commission implementing regulation;










R.


whereas the requests made by Denmark, Belgium and Germany, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, for the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ not to apply or for the conditions of that authorisation to be adjusted in their respective territories were also made on the grounds that alternatives for fuel preservation without halogenated compounds are available (12);










S.


whereas Article 5, point (c), of the Stockholm Convention provides that, to reduce the total releases derived from anthropogenic sources of each of the chemicals listed in Annex C to that Convention, with the goal of their continuing minimisation and, where feasible, ultimate elimination, each party shall at a minimum, where it deems it appropriate, require the use of substitute or modified materials, products and processes to prevent the formation and release of the chemicals listed in that Annex;










T.


whereas Article 6(2) of Regulation (EU) 2019/1021 obliges Member States to provide for measures ‘to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases of substances listed in Annex III’ to that Regulation and, where it is considered appropriate, to ‘require the use of substitute or modified substances, mixtures, articles and processes to prevent the formation and release of substances listed in [that] Annex’;










U.


whereas, according to the BPC opinion of 5 March 2020, one of the co-formulants of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ was identified as potentially having endocrine-disrupting properties; whereas it was, however, not possible to reach a conclusion as to whether that co-formulant meets the scientific criteria for the determination of endocrine-disrupting properties as laid down in Commission Delegated Regulation (EU) 2017/2100 (13); whereas, regarding the co-formulant identified as potentially having endocrine-disrupting properties, a process under REACH will be triggered by the eCA (France) in line with paragraph 31(b) of the note CA-March18-Doc.7.3.b-final entitled ‘The implementation of scientific criteria for the determination of endocrine-disrupting properties in the context of biocidal product authorisation’;












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) 2019/1021 and the requirements of the Stockholm Convention;












3.


Considers that the draft Commission implementing regulation to grant a Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ is not proportionate in light of:






(a)


the scientific uncertainty as to the levels of the risks to human health and the environment due to the exposure to dioxins via the environment from the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’,










(b)


the availability of alternatives for fuel preservation without halogenated compounds, and










(c)


the unacceptable risks that exposure to dioxins poses to human health and the environment, and the insufficient data for reaching a conclusion as to whether this authorisation would be in line with the objectives and provisions of the Stockholm Convention and of Regulation (EU) 2019/1021;
















4.


Considers that therefore the Commission should not have granted an authorisation to the biocidal product family ‘CMIT/MIT SOLVENT BASED’ or, at a minimum, should have required the applicant to provide more data as to the amount of formation of dioxins and the overall contribution to the emissions of dioxins due to the use of that biocidal product family in fuels used for road and water transport, and to clarify the level of the risks to human health and the environment due to the exposure to dioxins via the environment from the use of that biocidal product family, in order for the Commission to determine whether the risks can be considered acceptable or not in view of the aims of the Stockholm Convention;












5.


Calls on the Commission to withdraw its draft implementing regulation and to submit a new draft to the committee;












6.


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)  OJ L 169, 25.6.2019, p. 45.

(3)  OJ L 55, 28.2.2011, p. 13.

(4)  OJ L 209, 31.7.2006, p. 3.

(5)  OJ L 81, 19.3.2004, p. 37.

(6)  BPC opinion of 5 March 2020 on the Union authorisation of the biocidal Product Family: CMIT/MIT SOLVENT BASE, Product type: 6, ECHA/BPC/246/2020.

(7)  World Health Organization (2019): Preventing disease through healthy environments: Exposure to dioxins and dioxin-like substances: a major public health concern, https://www.who.int/publications/i/item/WHO-CED-PHE-EPE-19.4.4

(8)  Commission report of 4 January 2019 on the review and update of the second European Union Implementation Plan in accordance with Article 8(4) of Regulation (EC) No 850/2004 on persistent organic pollutants, COM(2018)0848, https://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-848-F1-EN-MAIN-PART-1.PDF

(9)  BPC opinion of 5 July 2021 on a request according to Article 75(1)(g) of Regulation (EU) No 528/2012 on the evaluation of dioxins emissions from the use of the biocidal product family (BPF) ‘CMIT/MIT SOLVENT BASED’ in fuels used in road and ship transport (ECHA/BPC/283/2021).

(10)  Communication of the Commission of 11 December 2019 on the European Green Deal, COM(2019)0640.

(11)  Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).

(12)  For example: glutaraldehyde and dimorpholinomethane are approved for PT 6; reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) (MBO), 1,2-Benzisothiazol-3(2H)- one (BIT), ethylenedioxy)dimethanol, 2-octyl-2H-isothiazol-3-one (OIT), 2-methyl-2H-isothiazol-3-one (MIT), pyrithione zinc, 2,2’,2”-(hexahydro- 1,3,5-triazine- 1,3,5-triyl)triethanol, pyridine-2-thiol 1-oxide sodium salt are in the review programme.

(13)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).