Case C‑616/17

Criminal proceedings against

Mathieu Blaise and Others

(Request for a preliminary ruling, made by the tribunal correctionnel de Foix)

Judgment of the Court (Grand Chamber) of 1 October 2019

(Reference for a preliminary ruling — Environment — Placing of plant protection products on the market — Regulation (EC) No 1107/2009 — Validity — Precautionary principle — Definition of the concept of ‘active substance’ — Combination of active substances — Reliability of the assessment procedure — Public access to the dossier — Tests of long-term toxicity — Pesticides — Glyphosate )

1. Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Application of the precautionary principle — Judicial review — Limits — Manifest error of assessment

   (Arts 9 and 168(1), TFEU; Charter of Fundamental Rights of the European Union, Art. 35; Regulation of the European Parliament and of the Council No 1107/2009, recital 8 and Art. 1(2) and (4))

   (see paragraphs 41, 42, 46, 47, 49)

2. Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Concept of active substance — Concept not defined — Manifest error of assessment — None — Infringement of the precautionary principle — None

   (Regulation of the European Parliament and of the Council No 1107/2009, Arts 2(2) and (3), and 33(3)(b))

   (see paragraphs 52-54, 56, 60)

3. Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Approval of an active substance — Assessment of risks — Criteria — Taking account of the potential cumulative effects of the constituents of that product — Manifest error of assessment — None — Infringement of the precautionary principle — None

   (Regulation of the European Parliament and of the Council No 1107/2009, Arts 4(1) to (3) and (5), 11(2), and 36(1))

   (see paragraphs 62-67, 75)

4. Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Approval of an active substance — Application for approval — Tests and studies provided by the applicant to show that the products have no harmful effect — No independent counter-analysis — Manifest error of assessment — None — Infringement of the precautionary principle — None

   (Regulation of the European Parliament and of the Council No 1107/2009, Arts 7(1), 8(1) and (2), 29(2) and (3), and 33(3)(a) and (b))

   (see paragraphs 77-79, 81, 84, 87, 89-94, 99)

5. Environment — Freedom of access to information — Directive 2003/4 — Grounds for refusal to disclose information relating to the environment — Request for access to information submitted in the procedure for placing on the market a plant protection product or biocide — Confidentiality of commercial or industrial information — Not included

   (Regulation of the European Parliament and of the Council No 1107/2009, Art. 63(3); Directive of the European Parliament and of the Council 2003/4, Art. 4(2))

   (see paragraphs 105-107)

6. Agriculture — Approximation of laws — Placing of plant protection products on the market — Regulation No 1107/2009 — Marketing authorisation for plant protection products — Conditions — No immediate or delayed harmful effects on human health — Exemption from submitting tests of the long-term toxicity of products — None

   (Regulation of the European Parliament and of the Council No 1107/2009, Arts 4(3)(b), and 29(1)(e) and (2))

   (see paragraphs 112-114)

Résumé

There are no grounds to question the validity of the regulation concerning the marketing of plant protection products such as glyphosate

In its judgment Blaise and Others (C‑616/17), delivered on 1 October 2019, the Grand Chamber of the Court gave a ruling on the validity, in the light of the precautionary principle, of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. ( 1 ) The request was made in criminal proceedings brought against Mr Blaise and 20 other defendants charged with damaging or defacing property belonging to another person, while acting together. Those individuals entered shops in the department of Ariège (France) and damaged cans of weed killer, containing glyphosate, and glass display cases. To justify their actions, intended to alert shops and their customers to the dangers associated with selling weed killers containing glyphosate, the defendants pleaded the precautionary principle. In order to give a ruling on whether that argument is well founded, the referring court considered that it had to determine the validity of Regulation No 1107/2009 in the light of that precautionary principle and therefore referred questions to the Court on that point.

Defining the scope of that principle, the Court, first, stated that the EU legislature must comply with that principle when it adopts rules governing the placing on the market of plant protection products. Since the purpose of Regulation No 1107/2009 is to lay down rules for the authorisation of plant protection products and the approval of the active substance contained in those products, so that they can be placed on the market, the EU legislature had to establish a normative framework to ensure that the competent authorities have available to them, when they decide on that authorisation and that approval, sufficient information in order adequately to assess the risks to health resulting from the use of those active substances and those plant protection products. In that regard, the Court emphasised that in view of the need to strike a balance between a number of objectives and principles, and of the complexity of the application of the relevant criteria, judicial review by the Court must necessarily be limited to the question whether the EU legislature committed a manifest error of assessment.

Second, the Court held that the absence of a definition of the concept of an ‘active substance’ in the regulation is not incompatible with the precautionary principle. An applicant is bound to declare, when submitting his application for authorisation of a plant protection product, any substance that forms part of the composition of that product that corresponds to the criteria set out in the regulation. An applicant does not, therefore, have the option of choosing at his discretion which constituent of that product is to be considered to be an active substance. In thereby determining the obligations imposed on the applicant in relation to the identification of active substances, the EU legislature did not commit a manifest error of assessment.

Further, the Court held that the regulation is compatible with the precautionary principle, in that it requires that the cumulative effects of the constituents of a plant protection product must be taken into account. The procedure for the approval of active substances and the procedure for the authorisation of plant protection products provide that an examination of applications is to include an assessment of the possible harmful effect of a product, including effects caused by the interaction between the constituents of the product. On that point, the regulation is again not vitiated by any manifest error of assessment.

The Court came to the same conclusion with respect to the reliability of the tests, studies and analyses taken into account in order to authorise a plant protection product. In the view of the Court, the fact that the tests, studies and analyses required in the procedures for the approval of an active substance and authorisation of plant protection products are submitted by the applicant, with no independent counter-analysis, does not involve any breach of the precautionary principle. The regulation requires, in that regard, the applicant to submit proof that products have no harmful effect, regulates the quality of the tests and analyses submitted, and confers on the competent authorities, who have to decide on an application, the responsibility of undertaking an objective and independent assessment. In that context, those authorities must necessarily take into account relevant information other than that submitted by the applicant and, in particular, the most reliable scientific data available and the most recent results of international research, and must not give in all cases preponderant weight to the studies provided by the applicant. Last, the Court stated that the regulation does not exempt the applicant from providing tests of the carcinogenicity and toxicity of the product. Such a product may be authorised only if the competent authorities exclude the risk of any immediate or delayed harmful effect on human health.

Consequently, nothing capable of affecting the validity of the regulation was identified.

( 1 ) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1).