62021TJ0274_RES
Case T‑274/21
Syndicat national des compléments alimentaires (Synadiet)
v
European Commission
Judgment of the General Court (Sixth Chamber, Extended Composition) of 13 November 2024
(Consumer protection – Substances prohibited, restricted or under EU scrutiny – Article 8(1) and (2) of, and Annex III to, Regulation (EC) No 1925/2006 – Prohibition and placing under scrutiny of certain substances and preparations containing hydroxyanthracene derivatives – First, second and third entries in Article 1(1), and Article 1(2), of Regulation (EU) 2021/468 – Concepts of ‘substance’, ‘ingredient’ and ‘preparations’ – Error of law)
Approximation of laws – Foods – Addition of vitamins and minerals and of certain other substances – Regulation No 1925/2006 – Substances prohibited, restricted or placed under EU scrutiny – Placement under scrutiny of certain substances and preparations containing hydroxyanthracene derivatives (HADs) – Concepts of substances, ingredients and preparations – Scope – Commission may not place certain preparations containing HADs under EU scrutiny
(European Parliament and Council Regulation No 1925/2006, Art. 8(1) and (2)(b), Annex III, Part C; Commission Regulation 2021/468, Art. 1, paragraph 2)
(see paragraphs 39-42, 44-48, 51-57)
Approximation of laws – Foods – Addition of vitamins and minerals and of certain other substances – Regulation No 1925/2006 – Commission decision to impose a ban on the addition to foods or the use in the manufacture of foods of a substance – Complex technical or scientific assessments – Broad discretion – Judicial review – Limits
(European Parliament and Council Regulation No 1925/2006, Art. 8(1) and (2)(a)(i), Annex III, Part A; Commission Regulation 2021/468)
(see paragraphs 62-64)
Approximation of laws – Foods – Addition of vitamins and minerals and of certain other substances – Regulation No 1925/2006 – Substances prohibited, restricted or placed under EU scrutiny – Commission decision to impose a total ban on the addition to foods or the use in the manufacture of foods of certain substances and preparations containing hydroxyanthracene derivatives (HADs) – Lack of scientific data to establish a risk threshold – Error of law
(European Parliament and Council Regulation No 1925/2006, Art. 8(1) and (2)(a)(i), Annex III, Part A; Commission Regulation 2021/468, Art. 1(1), first, second and third entries)
(see paragraphs 68-70, 73-81, 85-87)
Résumé
Ruling in extended composition with five judges, the General Court upholds the action brought by the Syndicat national des compléments alimentaires (Synadiet) and Others for the annulment of Regulation 2021/468, (
1
) and in particular Article 1 thereof, by which the European Commission included certain hydroxyanthracene derivatives (‘HADs’) and certain preparations containing HADs in the list in Parts A and C of Annex III to Regulation No 1925/2006. (
2
) The Court thus clarifies the scope of the concept of ‘preparations’ provided for in Regulation 2021/468 and rules, for the first time, on the conditions in which the Commission may rely on Article 8(2)(a)(i) of Regulation No 1925/2006 (
3
) to include substances or ingredients in Part A of Annex III to that regulation.
The applicants are trade unions and associations of undertakings whose purpose is, inter alia, to defend the interests of companies that manufacture and market products, food supplements or ingredients composed of various species of Aloe, senna, (
4
) rhubarb, (
5
) and cascara (
6
) containing HADs, including emodin and aloe-emodin. HADs are chemical substances that are naturally occurring in different botanical species, such as certain species of Aloe as well as certain fruits and vegetables. They are widely used in food supplements and herbal medicinal products for their laxative effect.
On 29 June 2016, the Commission asked the European Food Safety Authority (EFSA) to evaluate the available information on the safety of the use of HADs (
7
) and to recommend a daily intake of HADs that does not give rise to concerns about possible harmful effects on health for the general population.
On 22 November 2017, EFSA adopted a scientific opinion in which it concluded that emodin, aloe-emodin and aloe extracts have been shown to be genotoxic in vitro. According to the same opinion, whole leaf aloe extract was carcinogenic to rats. Given that aloe-emodin and emodin could be present in those extracts, it was concluded that HADs should be regarded as genotoxic and carcinogenic, in the absence of specific data to the contrary, and that there was a safety concern for extracts containing HADs, although uncertainty persisted. EFSA has not issued any advice on a daily intake of HADs that does not give rise to concerns about harmful effects to health for the general population.
On 18 March 2021, the Commission adopted Regulation 2021/468, by which it considered that, considering the severe harmful effects on health associated with the use of aloe-emodin, emodin and aloe extracts containing HADs in food, those substances and all preparations in which they are present should be prohibited and included in Part A of Annex III to Regulation No 1925/2006. (
8
) Furthermore, as there was a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations containing HADs in food, but scientific uncertainty persisted regarding whether such preparations contained the substances listed in Part A of Annex III to Regulation No 1925/2006, the Commission decided that such substances had to be placed under EU scrutiny and therefore included them in Part C of Annex III to Regulation No 1925/2006. (
9
)
Findings of the Court
In the first place, the Court rules on the question whether Article 8(2) of Regulation No 1925/2006 allows ‘preparations’ to be listed in Part C of Annex III to that regulation.
In those circumstances, the Court examines whether the concept of ‘preparations’ provided for in Regulation 2021/468 (
10
) might correspond to the concept of ‘substance other than vitamins or minerals’ or to that of ‘ingredient containing a substance other than vitamins or minerals’ provided for in Regulation No 1925/2006. (
11
) The Court notes at the start of its examination that those concepts are not expressly defined in the regulations.
First, as regards the concept of ‘substance other than vitamins or minerals’, the Court observes that it constitutes the specific expression of the concept of ‘other substance’ provided for in Regulation No 1925/2006. (
12
) It points out that the latter concept is defined on a residual basis, that is to say by excluding vitamins or minerals, which are the subject of specific provisions of the regulation, and merely by stating that it has a nutritional or physiological effect.
Second, as regards the concept of ‘ingredient’ provided for in Regulation No 1925/2006, the Court notes that it is presented by reference to the ‘substance’ it contains, which implies that it is the harmful effect of the substance that makes the ingredient containing it unsafe, thereby leading to a possible ban on its addition to foods or its use in the manufacture of foods under Article 8 (
13
) of that regulation.
Third, as regards the concept of ‘preparations’, the Court notes that it is defined in the EFSA guidance, but that the definition is not binding on the EU Courts. It is thus for the EU Courts to provide a binding interpretation of that concept. The Court also points out that the circular definition of the concept of ‘preparations’ given in the 2009 EFSA guidance does not allow for a precise interpretation.
In the light of the foregoing, the Court considers that the concept of ‘preparations’ provided for in Regulation 2021/468 has a broader scope and meaning than the concepts of ‘substance’ and ‘ingredient’ provided for in Regulation No 1925/2006, in so far as a preparation may contain a ‘substance’ or an ‘ingredient’. In the present case, that concept cannot replace them, since it is capable of encompassing all types of processed foods. Since those terms evoke different concepts, the placement of ‘preparations’ under EU scrutiny cannot have the same scope as it would in the case of substances or, as the case may be, ingredients.
Accordingly, the Court annuls Article 1(2) of Regulation 2021/468, by which the Commission placed preparations from Rheum, Cassia and Rhamnus containing HADs under EU scrutiny. Indeed, in adopting that provision, the Commission could not rely on Article 8(2)(b) of Regulation No 1925/2006, which only allows the inclusion of a ‘substance’ in Part C of Annex III to that regulation.
In the second place, the Court rules on the conditions in which the Commission may rely on Article 8(2)(a)(i) of Regulation No 1925/2006 to include a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, in Part A of Annex III to that regulation.
As a preliminary point, the Court recalls that, in accordance with the case-law, in complex technical or scientific assessments, the Commission has a broad discretion, which limits judicial review to determining whether the procedural rules have been complied with, whether the facts established by the Commission are correct and whether there has been a manifest error of appraisal of those facts or a misuse of powers. However, as regards the Commission’s conclusions which do not involve complex technical or scientific assessments, the Court has full jurisdiction to review them.
In that context, the Court emphasises the essential role assigned to a scientific assessment by EFSA of the effect of the addition of a substance, or an ingredient containing that substance, to foods or of its use in the manufacture of foods. Indeed, the aim of the mandatory consultation of EFSA is to provide the Commission with the evidence of scientific assessment which is essential for it to be able to determine, in full knowledge of the facts, the appropriate measures to ensure a high level of public health protection.
The Court sets out the conditions in which, under Article 8(2)(a)(i) of Regulation No 1925/2006, the Commission may decide to prohibit the addition to foods or the use in the manufacture of foods of a substance other than vitamins or minerals, or of an ingredient containing that substance. Those conditions concern, on the one hand, the ingestion of amounts of the substance in question greatly exceeding those expected to be ingested under normal conditions of a balanced and varied diet, and on the other hand, the identification of a harmful effect on health.
As regards the first of those conditions, the Court points out that EFSA was unable to provide advice on a daily intake of HADs that does not give rise to concerns for human health. However, Regulation 2021/468 prohibits aloe-emodin, emodin and any preparations in which those substances are present, and preparations from the leaf of Aloe species containing HADs. In that context, the Commission therefore appears to have taken the view that the insufficiency of data relating to a daily intake that does not give rise to concern for health allowed it to assume that there was no level for safe use of HADs, with the result that it could prohibit them entirely. However, the absence of a threshold is contrary to Article 8(2)(a)(i) of Regulation No 1925/2006, which provides that the prohibition procedure presupposes that a harmful effect on health has been identified where substances other than vitamins or minerals, or ingredients containing them, are added to foods or used in their manufacture, resulting in ingestion of amounts of those substances greatly exceeding those expected to be ingested under normal conditions of a balanced and varied diet.
Accordingly, the Court considers that the general prohibition on the addition to foods or the use in the manufacture of foods of all the substances and preparations at issue, regardless of the amount of HADs they contain, does not comply with the conditions required by Article 8(2)(a)(i) of Regulation No 1925/2006. In the absence of data on the amount of the substance that can ‘be ingested through eating an adequate and varied diet’ or on the amounts that are ‘reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet’ within the meaning of Regulation No 1925/2006, (
14
) food business operators, who are responsible for the safety of the foods they place on the market and assume the burden of proof in relation to their safety, are not in a position to make an appropriate comparison between, on the one hand, the amounts of a substance under normal conditions of consumption and, on the other hand, the amounts of that same substance under the conditions of use and addition as concentrates.
In the light of the foregoing, the General Court annuls the first, second and third entries in Article 1(1) of Regulation 2021/468. It considers that that provision infringes Article 8(2)(a)(i) of Regulation No 1925/2006, in so far as it prohibits the HADs aloe-emodin and emodin, and preparations in which those substances are present, as well as preparations from the leaves of Aloe species containing HADs, from being added to foods or used in the manufacture of foods, irrespective of the amount of HADs concerned.
(
1
)	Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (OJ 2021 L 96, p. 6), and in particular the first, second and third entries in Article 1(1) and the first and second entries in Article 1(2).
(
2
)	Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ 2006 L 404, p. 26).
(
3
)	Under that provision, the Commission may decide to include, if necessary, a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, in Part A of Annex III to that regulation, where the substance or ingredient in question has a harmful effect on health. If included, the addition of the substance or ingredient to foods or its use in the manufacture of foods will be prohibited.
(
4
)	Cassia angustifolia Vahl.
(
5
)	Including Rheum palmatum L. and Rheum officinale Baillon.
(
6
)	Including Rhamnus frangula L. and Rhamnus purshiana.
(
7
)	On the basis of Article 8(1) and (2) of Regulation No 1925/2006.
(
8
)	First, second and fourth entries in Article 1(1) of Regulation 2021/468.
(
9
)	First, second and third entries in Article 1(2) of Regulation 2021/468.
(
10
)	More specifically the first and second entries in Article 1(2) of Regulation 2021/468.
(
11
)	More specifically Article 8(1) and (2)(a)(i) and (b) of Regulation No 1925/2006.
(
12
)	Defined more specifically in Article 2(2) of Regulation No 1925/2006.
(
13
)	Article 8(2)(a)(i) of Regulation No 1925/2006.
(
14
)	As set out in recital 20 and Article 8(1) of Regulation No 1925/2006.