62021CC0830
OPINION OF ADVOCATE GENERAL
MEDINA
delivered on 20 April 2023 (
1
)
Case C‑830/21
Syngenta Agro GmbH
v
Agro Trade Handelsgesellschaft mbH
(Request for a preliminary ruling from the Hanseatisches Oberlandesgericht Hamburg (Higher Regional Court, Hamburg, Germany))
(Reference for a preliminary ruling – Approximation of laws – Plant protection products – Regulation (EC) No 1107/2009 – Article 28 – Authorisation for placing on the market and use – Article 52 – Parallel trade – Commission Regulation (EU) No 547/2011 – Article 1 – Paragraph 1(b) and (f) of Annex I – Labelling requirements – Name and address of the holder of the authorisation – Formulation batch number)
I. Introduction
1.
This request for a preliminary ruling concerns the interpretation of Article 1 of Regulation (EU) No 547/2011, (
2
) read in combination with paragraph 1(b) and (f) of Annex I thereto. That regulation implements Regulation (EC) No 1107/2009 (
3
) as regards labelling requirements for plant protection products.
2.
The reference has been made in proceedings between Syngenta Agro GmbH (‘the appellant’) and Agro Trade Handelsgesellschaft mbH (‘the respondent’), which result from a dispute concerning the parallel importation into Germany of plant protection products authorised to be placed on the market by the appellant in other Member States of the European Union.
3.
In the present case, the Court is requested to determine to what extent the labelling requirements that apply to the granting of an authorisation for placing a plant protection product on the market in a Member State, under Article 28(1) of Regulation No 1107/2009, are also applicable to a situation involving the parallel trade of that product, pursuant to Article 52 of Regulation No 1107/2009.
II. Legal framework
A.
European Union law
1. Regulation No 1107/2009
4.
Recitals 8, 9, 24, 31, 42, 44 and 45 of Regulation No 1107/2009 state:
‘8.
The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. …
9.
In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules for the approval of active substances and the placing on the market of plant protection products, including the rules on the mutual recognition of authorisations and on parallel trade. The purpose of this Regulation is thus to increase the free movement of such products and availability of these products in the Member States.
…
24.
The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they present a clear benefit for plant production and do not have any harmful effect on human or animal health, including that of vulnerable groups, or any unacceptable effects on the environment.
…
31.
Where identical plant protection products are authorised in different Member States, a simplified procedure for granting a parallel trade permit should be provided for in this Regulation, in order to facilitate the trade between Member States of such products.
…
42.
Directive 1999/45/EC [ (
4
)]… applies to the classification, packaging and labelling of plant protection products. However, to improve further the protection of users of plant protection products, of consumers of plants and plant products and of the environment, further specific rules are appropriate which take account of the specific conditions of use of plant protection products.
…
44.
Provisions on record-keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality.
45.
Provisions on control and inspection arrangements with regard to the marketing and use of plant protection products should ensure correct, safe and harmonised implementation of the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment.’
5.
Article 1 of Regulation No 1107/2009, under the heading ‘Subject matter and purpose’, states:
‘…
3.   The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.
…’
6.
Article 3 of the same regulation, headed ‘Definitions’, provides:
‘For the purposes of this Regulation, the following definitions shall apply:
…
10.
“authorisation of a plant protection product” means an administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory;
…
24.
“authorisation holder” means any natural or legal person holding an authorisation of a plant protection product;
…’
7.
Article 28 of Regulation No 1107/2009, headed ‘Authorisation for placing on the market and use’, provides:
‘1.   A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.
2.   By way of derogation from paragraph 1, no authorisation shall be required in the following cases:
…
(e)
placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.’
8.
Article 29 of Regulation No 1107/2009, headed ‘Requirements for the authorisation for placing on the market’, provides:
‘1.   Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements:
…’
9.
Article 33 of that regulation, under the heading ‘Application for authorisation or amendment of an authorisation’, provides:
‘1.   An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market.
…
3.   The application shall be accompanied by the following:
…
(g)
a draft label.’
10.
Article 44 of Regulation No 1107/2009, headed ‘Withdrawal or amendment of an authorisation’, provides, in paragraphs 1, 3 and 4:
‘1.   Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied.
…
3.   The Member State shall withdraw or amend the authorisation, as appropriate, where:
(a)
the requirements referred to in Article 29 are not or are no longer satisfied;
(b)
false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted;
(c)
a condition included in the authorisation has not been met;
(d)
on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or
(e)
the authorisation holder fails to comply with the obligations resulting from this Regulation.
4.   Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the [European] Commission and the [European Food Safety] Authority …’
11.
Article 52 of Regulation No 1107/2009, headed ‘Parallel trade’, provides:
‘1.   A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product). The application shall be submitted to the competent authority of the Member State of introduction.
2.   From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure … if the plant protection product to be introduced is identical in terms of paragraph 3 …
3.   Plant protection products shall be considered as identical to the reference products if:
(a)
they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
(b)
they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and
(c)
they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
4.   The application for a parallel trade permit shall include the following information:
(a)
the name and registration number of the plant protection product in the Member State of origin;
(b)
the Member State of origin;
(c)
the name and address of the authorisation holder in the Member State of origin;
(d)
the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction. This competent authority may require a translation of the relevant parts of the original instructions for use;
(e)
the name and address of the applicant;
(f)
the name to be given to the plant protection product to be distributed in the Member State of introduction;
(g)
a draft label for the product intended to be placed on the market;
(h)
a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
(i)
the name and registration number of the reference product.
….
5.   A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product. To facilitate monitoring and controls the Commission shall set out specific control requirements for the product to be introduced in a Regulation referred to in Article 68.
6.   The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired.
7.   Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.
8.   Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.
9.   Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.
…
11.   Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits.’
12.
Article 55 of Regulation No 1107/2009, under the heading ‘Use of plant protection products’, provides:
‘Plant protection products shall be used properly.
Proper use shall include the application of the principles of good plant protection practice and compliance with the conditions established in accordance with Article 31 and specified on the labelling …’
13.
Article 56 of that regulation, under the heading ‘Information on potentially harmful or unacceptable effects’, establishes in paragraph 4:
‘The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plant, plant products or the environment.’
14.
Article 65 of Regulation No 1107/2009, headed ‘Labelling’, states:
‘1.   The labelling of plant protection products shall include the classification, labelling and packaging requirements of [Directive 1999/45] and shall comply with the requirements set out in a Regulation adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
…’
2. Regulation No 547/2011
15.
Pursuant to Article 65(1) of Regulation No 1107/2009, the Commission adopted Regulation No 547/2011.
16.
Article 1 of Regulation No 547/2011 provides:
‘The labelling of plant protection products shall comply with the requirements, as set out in Annex I, and contain, where appropriate, the standard phrases for special risks to human or animal health or to the environment, as set out in Annex II, and the standard phrases for safety precautions for the protection of human or animal health or of the environment, as set out in Annex III.’
17.
Annex I to Regulation No 547/2011, headed ‘Labelling requirements referred to in Article 1’, provides as follows:
‘(1)   The following information shall be included clearly and indelibly on the packaging of plant protection products:
…
(b)
the name and address of the holder of the authorisation and the authorisation number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;
…
(f)
the formulation batch number and production date;
…’
3. Regulation (EC) No 1272/2008
18.
Directive 1999/45, as referred to in Article 65(1) of Regulation No 1107/2009, was repealed and replaced by Regulation (EC) No 1272/2008. (
5
)
19.
Recital 18 of Regulation No 1272/2008 states:
‘To ensure that customers receive information on hazards, suppliers of substances and mixtures should ensure that they are labelled and packaged in accordance with this Regulation before placing them on the market, according to the classification derived …’
20.
Article 1 of Regulation No 1272/2008, headed ‘Purpose and scope’, provides:
‘1.   The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:
…
(b)
providing an obligation for:
…
(ii)
suppliers to label and package substances and mixtures placed on the market;
…’
21.
Article 2 of that regulation, headed ‘Definitions’, provides as follows:
‘For the purpose of this Regulation, the following definitions shall apply:
…
26. “supplier” means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;
…’
22.
In Title III of that regulation, concerning ‘Hazard communication in the form of labelling’, Article 17 of Regulation No 1272/2008, headed ‘General rules’, provides:
‘1.   A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:
(a)
the name, address and telephone number of the supplier(s);
…’
B.
German law
23.
Paragraph 49(4), first sentence, of the Gesetz zum Schutz der Kulturpflanzen (Law on the protection of cultivated plants) lays down the following rule for the parallel trade in plant protection products:
‘Permit holders which do not use the batch number of the holder of the authorisation for the plant protection product imported in parallel for the label referred to in Paragraph 47(1) must keep records, to be retained for at least five years, showing the correlation between the batch number which they use and the batch numbers of the holder of the authorisation of the plant protection product imported in parallel.’
III. The facts in the main proceedings and the questions referred
24.
The appellant is a distribution company of the Syngenta group, which manufactures and distributes plant protection products in Germany and other Member States of the European Union. The respondent is a trading company in the agricultural sector, which distributes plant protection products, including plant protection products imported in parallel.
25.
Those parallel-imported products include the appellant’s plant protection products. The respondent distributes them in Germany from third Member States, in the appellant’s original unopened canisters, on which it replaces the original label with its own self-adhesive label. That label includes information on the respondent as the importer and distributor, but not on the appellant as the holder of the authorisation of the plant protection product in the Member State of origin. The respondent also replaces the manufacturer’s original formulation batch number with its own identification number and keeps a register showing the correlation between the identification number allocated by it and the original batch number.
26.
In an action before the Landgericht Hamburg (Regional Court, Hamburg, Germany), hearing the case at first instance, the appellant claimed that, by its conduct, the respondent infringed Article 1 of Regulation No 547/2011, read in combination with paragraph 1(b) and (f) of Annex I thereto. It therefore sought an order compelling the respondent to desist from placing on the market in Germany the appellant’s plant protection products which had been imported in parallel: (i) where the information on the name and address of the authorisation holder, affixed to the original packaging, had been removed and/or (ii) where the formulation batch number printed on the original packaging had been removed and replaced by another identification number. In relation to those claims, the appellant asked that court to require the respondent to provide it with information, pay damages and reimburse the costs of pre-litigation proceedings.
27.
The Landgericht Hamburg (Regional Court, Hamburg) upheld the appellant’s claim based on paragraph 1(b) of Annex I to Regulation No 547/2011, regarding the information on the name and address of the holder of the authorisation. However, it dismissed the claim based on paragraph 1(f) of that annex, regarding the formulation batch number. Both the appellant and the respondent have appealed against that judgment before the Hanseatisches Oberlandesgericht Hamburg (Higher Regional Court, Hamburg, Germany), the referring court in the present case.
28.
In the order of reference, the referring court explains that the infringement of the labelling requirements set out by Regulation No 547/2011 could serve as a valid ground to uphold the claims of the appellant under national competition law, namely the Gesetz gegen den unlauteren Wettbeweb (Law on Unfair Competition). However, it harbours doubts as to the proper interpretation of paragraph 1(b) and (f) of Annex I to Regulation No 547/2011, inasmuch as that regulation does not lay down any specific rule vis-à-vis the labelling of plant protection products which have been the subject of parallel trade. According to the referring court, whereas the wording of those provisions could, as the appellant maintains, support the view that it is necessary to indicate, on the label of the imported product, both the name and address of the holder of the authorisation in the Member State of origin and the original formulation batch number, the objectives of Regulation No 1107/2009 as regards parallel trade could also allow for a broader interpretation, as argued by the respondent.
29.
It is in those circumstances that the Hanseatisches Oberlandesgericht Hamburg (Higher Regional Court, Hamburg) has decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1)
Is Article 1 of Regulation [No 547/2011], read in combination with paragraph 1(b) of Annex I thereto, to be interpreted as meaning that, in the case of a parallel import of a plant protection product, the name and address of the holder of the authorisation in the Member State of origin from which the plant protection product was imported must be stated on the packaging when it is distributed in another Member State?
(2)
Is Article 1 of Regulation [No 547/2011], read in combination with paragraph 1(f) of Annex I thereto, to be interpreted as meaning that, in the case of a parallel import of a plant protection product, the batch number initially allocated by the manufacturer must be indicated on the packaging, or is it compatible with that provision for the parallel importer to remove the original batch number and to affix its own identification number to the packaging, provided it keeps records showing the correlation between the batch numbers used by it and the batch numbers used by the holder of the authorisation of the plant protection product imported in parallel?’
30.
The request for a preliminary ruling was lodged at the Court Registry on 23 December 2021. Written observations have been presented by the main parties before the referring court, the Republic of Greece, the Republic of Italy, the Republic of Austria and the Commission. No hearing has been held in the case.
IV. Assessment
31.
By its questions, the referring court is asking the Court to rule on the interpretation of Article 1 of Regulation No 547/2011, read in combination with paragraph 1(b) and (f) of Annex I thereto, in particular whether an importer who introduces and places on the market a plant protection product in a Member State, on the basis of a parallel trade permit, is obliged to retain on its labelling the name and address of the holder of the authorisation of that product in the Member State of origin (first question) and the formulation batch number initially provided by the manufacturer (second question), or may that importer replace those references with its own.
A.
First question
32.
The first question submitted by the referring court relates to the interpretation of Article 1 of Regulation No 547/2011 in combination with paragraph 1(b) of Annex I thereto.
33.
As a preliminary point, I should recall that, in order to remove obstacles to trade existing due to the different levels of protection in the Member States, Regulation No 1107/2009 lays down harmonised rules for the placing on the market of plant protection products. (
6
)
34.
That placing on the market is generally subject, pursuant to Article 28(1) of Regulation No 1107/2009, to the granting of an authorisation by the Member State concerned. An applicant who wishes to place a plant protection product on the market must apply for an authorisation in each Member State where the plant protection product is intended to be placed on the market. (
7
) As part of the procedure leading to the granting of that authorisation, the Member State must examine whether the requirements established by Regulation No 1107/2009 for the placing on the market of a plant protection product – mainly those arising from Article 29 of that regulation – are met. (
8
)
35.
The examination carried out by the Member State also encompasses the requirements applicable to the labelling of plant protection products.
36.
For that purpose, Regulation No 1107/2009 provides that the application for an authorisation must be accompanied by a draft label. (
9
) The labelling requirements applicable to plant protection products are those arising from Regulation No 1272/2008, which repealed and replaced Directive 1999/45, (
10
) as well as those defined in Regulation No 547/2011 by the Commission, following the express mandate established in that regard by Article 65(1) of Regulation No 1107/2009. (
11
) In particular, Article 1 of Regulation No 547/2011 states that the labelling of plant protection products must comply with the requirements set out in Annex I thereto, which, in turn, requires certain information to be included ‘clearly and indelibly’ on the packaging of plant protection products. According to paragraph 1(b) of that annex, that information includes ‘the name and address of the holder of the authorisation’.
37.
It follows from the foregoing that, in order to obtain an authorisation for placing a plant protection product on the market, pursuant to Article 28(1) of Regulation No 1107/2009, the appellant for that authorisation must provide inter alia, within its application, a draft label indicating the name and address of the holder of the authorisation. (
12
) Only if that information is displayed on the label of that product clearly and indelibly can an authorisation be granted by the Member State in which it is intended to be placed on the market.
38.
Nevertheless, the obligation to obtain an authorisation prior to the placing on the market of a plant protection product has several derogations. Those derogations are listed in Article 28(2) of Regulation No 1107/2009, which covers, inter alia, the placing on the market of a plant protection product for which a parallel trade permit has been issued in accordance with Article 52 thereof.
39.
As the Commission explains, Directive 91/414/EEC, (
13
) which was repealed by Regulation No 1107/2009, (
14
) did not contain any express provision relating to parallel trade. Yet, in the judgment in British Agrochemicals Association, (
15
) the Court ruled that the placing on the market of a Member State of a plant protection product authorised in another Member State should not require an additional authorisation, in particular where the product essentially corresponds to a plant protection product authorised in the Member State of introduction. (
16
) The Court has further established that the parallel trade of plant protection products must be subject to only a simplified procedure, directed, in essence, at ensuring compliance with the objective of a high level of protection of health and the environment. (
17
)
40.
In accordance with the Court’s case-law, Regulation No 1107/2009 incorporated Article 52, which, under the heading ‘Parallel trade’, aims to facilitate the trade between Member States of plant protection products. (
18
)
41.
In essence, Article 52 of Regulation No 1107/2009 covers situations where a plant protection product authorised in a Member State (Member State of origin) is placed on the market of another Member State (Member State of introduction) where an authorisation already exists for an identical product (reference product). (
19
) In that respect, that provision requires the granting of a parallel trade permit by the competent authority of the Member State of introduction, which is issued after a simplified procedure in which the identical character of the parallel-traded product and the reference product must be verified. (
20
)
42.
Regulation No 1107/2009 is, however, silent as regards the labelling requirements that apply to parallel-traded plant protection products and, in particular, as regards the first question raised in the present case, which is whether the packaging of those products must include the information regarding the name and address of the holder of the authorisation in the Member State of origin.
43.
In order to provide an answer to that question, it is important to recall that, according to settled case-law, when interpreting EU law, it is necessary to consider the wording of the provisions concerned, as well as their context and the objectives pursued by the rules of which they form part. (
21
)
44.
Concerning the literal interpretation, I observe that neither the wording of Article 1 of Regulation No 547/2011 nor that of paragraph 1(b) of Annex I thereto indicates whether the name and address of the holder of the authorisation in the Member State of origin must be indicated on the packaging of a plant protection product upon its parallel importation into the Member State of introduction. Nor does Article 28 of Regulation No 1107/2009 provide any clarity in that regard.
45.
By contrast, Article 52(7) of Regulation No 1107/2009 expressly provides that Chapter VII thereof, headed ‘Packaging, labelling and advertising of plant protection products and adjuvants’, is to be applied to parallel-traded plant protection products. That article specifies that that chapter is to be applied ‘correspondingly’.
46.
I note that Chapter VII of Regulation No 1107/2009 includes, inter alia, Article 65(1) thereof, which, as already indicated, stipulates that the labelling of plant protection products must comply with the requirements set out in Regulation No 547/2011. (
22
) It results therefore from Article 52(7) of Regulation No 1107/2009, read in conjunction with Article 65(1) of that regulation, that Article 1 of Regulation No 547/2011, as well as paragraph 1(b) of Annex I thereto, are applicable to plant protection products subject to parallel trade.
47.
Yet, the use of the term ‘correspondingly’ in the wording of Article 52(7) of Regulation No 1107/2009 should not be ignored. Indeed, that adverb (
23
) suggests that the labelling requirements applicable to the placing on the market of a plant protection product, through an authorisation granted in accordance with Article 28(1) of Regulation No 1107/2009, may be adapted if necessary so that they correspond to the specific features of the parallel trade of plant protection products. (
24
)
48.
Consequently, the question remains whether the parallel trade of a plant protection product, as arranged by Article 52 of Regulation No 1107/2009, means that Article 1 of Regulation No 547/2011, as well as paragraph 1(b) of Annex I thereto, are to be interpreted and applied differently in the context of the placing on the market of that product under Article 28(1) of Regulation No 1107/2009.
49.
The parties have expressed different views in their written pleadings in that regard. Whereas the Italian Government and the appellant consider that both situations must be subject to identical labelling requirements, including the reference to the name and address of the holder of the authorisation in the Member State of origin; the Republic of Greece, the Commission and the respondent consider, in essence, that an authorisation for placing a plant protection product on the market, on the one hand, and a parallel trade permit, on the other, are administrative measures of a different nature, with the result that the requirement under paragraph 1(b) of Annex I to Regulation No 547/2011 must be adapted when considering parallel trade. I invite the Court to endorse the latter interpretation.
50.
As already explained, the labelling requirement regarding the name and address of the holder of an authorisation, which applies to situations governed by Article 28(1) of Regulation No 1107/2009, results from the fact that it is precisely that holder who is responsible for the placing on the market of a plant protection product in the territory of a Member State. Indeed, as follows from reading Article 3(10) and (24) of Regulation No 1107/2009 together, it is that natural or legal person who is authorised by the competent authorities of the Member State, through a specific administrative measure, to place that product on the market for the first time once it has been verified that the applicable requirements within the procedure set out in that regulation have been met. (
25
)
51.
By contrast, in the case of parallel trade, based on Article 52 of Regulation No 1107/2009, it is the holder of the parallel trade permit who is responsible for the placing on the market of the plant protection product in the territory of the Member State of introduction once an assessment has been made that the product of introduction and the reference product are identical. (
26
) As the Court has recalled in the judgment in Agrimotion, (
27
) the parallel trade permit is personal in nature, which means, according to the Court, that only the holder of a parallel trade permit may place on the market the plant protection product concerned in the Member State which granted that permit. (
28
)
52.
It follows from the foregoing that, even if an authorisation granted under Article 28(1) of Regulation No 1107/2009, on the one hand, and a parallel trade permit issued pursuant to Article 52 of that regulation, on the other, share a similar role, (
29
) the first measure links its holder to the Member State of origin, whereas the second links its holder to the Member State of introduction. Within that context, the granting of an authorisation for placing a plant protection product on the market in the Member State of origin cannot be considered to give rise to any derived right for the holder of that authorisation in the Member State of introduction. Moreover, as the respondent submits, since, according to Article 28(2) of Regulation No 1107/2009, (
30
) parallel trade does not require an ‘authorisation’ in the Member State of introduction, but only to the issuing of a parallel trade permit, no ‘holder of an authorisation’ in that Member State can be considered to exist regarding, in particular, the parallel-traded product, meaning therefore that no reference to such a holder on the label of that product is necessary.
53.
In the light of the above, I take the view, in line with the position adopted by the Republic of Greece, the Commission and the respondent, that the requirement set out in paragraph 1(b) of Annex I to Regulation No 547/2011 referring to the name and address of the holder of the authorisation should be understood, in a situation of parallel trade, as referring to the name and address of the holder of the parallel trade permit. (
31
)
54.
I should point out that the interpretation above is also consistent with Regulation No 1272/2008, which, as indicated, is also applicable to the labelling of plant protection products pursuant to Article 65(1) of Regulation No 1107/2009. (
32
)
55.
Indeed, Article 1(b)(ii) of Regulation No 1272/2008 states that the purpose of that regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances by providing an obligation ‘for suppliers to label and package substances and mixtures placed on the market’. (
33
) More specifically, in Title III of Regulation No 1272/2008, concerning ‘Hazard communication in the form of labelling’, Article 17(1)(a) thereof provides that a substance or mixture classified as hazardous and contained in packaging must bear a label including ‘the name, address and telephone number of the supplier’. In turn, Article 2(26) of Regulation No 1272/2008 defines the term ‘supplier’ as any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture.
56.
It results from those provisions that either the manufacturer or the importer of the plant protection product must be indicated on the label of a plant protection product, but not both, which excludes the main argument put forward by the appellant in the main proceedings, namely that both information regarding the holder of the authorisation and information regarding the holder of the parallel trade permit must appear on the label on those products.
57.
A systematic and contextual reading of the relevant provisions of Regulation No 1107/2009, also taking into account Regulation No 1272/2008, invites to consider that the name and address of the holder of an authorisation of a plant protection product in the Member State of origin does not need to be indicated on the label on those products when traded in parallel. On the contrary, a combined reading of those provisions leads to the conclusion that Article 1 of Regulation No 547/2011, together with paragraph 1(b) of Annex I thereto, should be interpreted as requiring only the name and address of the holder of the parallel trade permit to be indicated on the label.
58.
Turning to the teleological interpretation, it is important to point out that, according to recitals 8 and 9 of Regulation No 1107/2009, that regulation pursues various objectives. On the one hand, it aims to ensure a high level of protection of both human and animal health and the environment and, at the same time, to safeguard the competitiveness of the EU agriculture. (
34
) On the other, it seeks to increase the free movement of plant protection products and their availability in the Member States by removing the differences in the levels of protection in the Member States and harmonising, in particular, the rules relating to the parallel trade in those products. Both objectives are expressly reiterated in Article 1(3) of Regulation No 1107/2009, which also refers to the aim of improving agricultural production. (
35
)
59.
In the first place, concerning the objective of ensuring a high level of protection of both human and animal health and the environment, it should be borne in mind, first, that, pursuant to Article 52(5) of Regulation No 1107/2009, a plant protection product for which a parallel trade permit has been issued must be placed on the market and used only in accordance with the provisions and requirements of the authorisation of the reference product. That means that the parallel trade permit must match the provisions, requirements and conditions established in the authorisation of the reference product seeking, in particular, to ensure the protection of human and animal health and the environment in the Member State of introduction. (
36
) Following a similar rationale, Article 52(6) of Regulation No 1107/2009 further stipulates that the validity of a parallel trade permit is limited to the validity of the authorisation of the identical reference product.
60.
Accordingly, whether for the consumer in the Member State of introduction or for competent authorities thereof – which are entrusted with the duty to ensure the correct, safe and harmonised implementation of the requirements laid down in Regulation No 1107/2009 – (
37
) the only relevant information for the purposes of making sure that a parallel-traded product is placed on the market and used in the same way as the reference product is the information relating to the parallel trade permit. (
38
) That information includes the name and address of its holder, who, as indicated previously, is the only person responsible for placing that particular plant protection product on the market of the Member State of introduction. (
39
) From that perspective, the information regarding the name and address of the holder of the authorisation in the Member State of origin becomes, in my view, superfluous.
61.
Moreover, as the respondent contends, an obligation to indicate the name of the holder of the authorisation in the Member State of origin could bring about an outcome that would be far from ideal for the purposes of ensuring the protection of health and the environment. Ultimately, such an indication could be misleading for users, who might be led to seek information on the requirements regarding the application of the plant protection product concerned in the Member State of origin, taking the view that those indications were also binding on them. Yet, as noted, the requirements regarding the application of a plant protection product – concerning, for instance, the crops to which it is to be applied, the doses, the number of applications and the conditions of application – can differ in every Member State. (
40
) There would therefore be a risk that that product might be used in such a way as to comply with the provisions, requirements and conditions of the Member State of origin, instead of those of the Member State of introduction.
62.
Second, it is true that, according to Article 52(8) of Regulation No 1107/2009, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy issues. In that context, the indication of the name and address of the holder of the authorisation in that Member State on the label of the plant protection product may appear to be relevant.
63.
However, as the Commission points out, the competent authority issuing the parallel trade permit in the Member State of introduction has at its disposal the necessary information enabling the origin of an imported product to be traced back directly to the holder of the authorisation in the Member State of origin. That specific information is expressly required by Article 52(4)(a) to (c) of Regulation No 1107/2009, which must accordingly be provided when applying for a parallel trade permit.
64.
Therefore, if the authorisation for the introduced plant protection product is withdrawn in the Member State of origin, which is a piece of information that needs to be transmitted immediately to the national authorities of the other Member States, (
41
) the competent authority in the Member State of introduction is able to withdraw the parallel permit concerned. That means that the potential impairment of the safety or efficacy of the plant protection product authorised in the Member State of origin does not justify deviating from an interpretation according to which the label of that product in the Member State of introduction need only indicate the name and address of the holder of the parallel permit.
65.
Third, it is worth noting that, by virtue of Article 52(7) of Regulation No 1107/2009, Article 44 and Article 56(4) of that regulation also apply to parallel-traded plant protection products correspondingly. Under the first of the latter provisions, a parallel trade permit may be withdrawn or amended in certain cases, which, in essence, concern situations where human and animal health and the environment could be put at risk. In turn, the second of those provisions establishes an annual obligation to report to the competent authorities any information available relating to the lack of expected efficacy, the development of resistance and any unexpected effect on plants, plant products or the environment. In both cases, it is the holder of the parallel trade permit that this applies to in the context of parallel trade for the purposes of protecting human and animal health and the environment, which justifies the indication of its name and address on the label on the product concerned. By contrast, the holder of the authorisation in the Member State of origin does not appear to play any role in that regard.
66.
It follows that my proposed interpretation of Article 1 of Regulation No 547/2011 and paragraph 1(b) of Annex I thereto, requiring, in the context of the parallel trade, information relating to the holder of a permit in the Member State of introduction to be indicated on the label of a plant protection product, instead of information relating to the holder of the authorisation in the Member State of origin, appears to satisfy fully the objective of ensuring a high level of protection of both human and animal health and the environment.
67.
In the second place, concerning the objective of Regulation No 1107/2009 to increase the free movement of plant protection products, I would merely point out that, to my mind, that interpretation is not capable of frustrating in any way that objective. Besides, it does not appear to have any (adverse) impact on the objectives defined in Regulation No 1107/2009 of safeguarding the competitiveness of and improving agriculture in the European Union.
68.
The teleological interpretation of the provisions concerned by the parallel trade of plant protection products does not call into question the interpretation resulting from the contextual and systematic interpretation of those same provisions as established in point 57 of the present Opinion. On the contrary, solely indicating the name and address of the holder of the parallel trade permit allows a high level of protection of human and animal health and the environment to be attained, while respecting the free movement of plant protection products, as general objectives of Regulation No 1107/2009. (
42
)
69.
In the light of the foregoing considerations, I must conclude that none of the methods of interpreting EU law has led me to consider that a plant protection product that is subject to parallel trade, in accordance with Article 52 of Regulation No 1107/2009, must display on its label the name and address of the holder of the authorisation in the Member State of origin. By contrast, Article 1 of Regulation No 1107/2009, read in combination with paragraph 1(b) of Annex I thereto, should be interpreted as meaning that an importer who introduces and places on the market a plant protection product in a Member State, on the basis of a parallel trade permit, may replace that information with its own.
B.
Second question
70.
The second question submitted by the referring court relates to the interpretation of Article 1 of Regulation No 547/2011 in conjunction with paragraph 1(f) of Annex I thereto. In particular, as already indicated in point 31 of the present Opinion, that court seeks guidance on whether those provisions must be interpreted as meaning that, in the case of the parallel trade, the formulation batch number initially allocated by the manufacturer to a plant protection product must appear as such on its packaging. The referring court also asks the Court to determine whether a national provision which allows that information to be replaced by the importer of a plant protection product is compatible with Regulation No 1107/2009 and Regulation No 547/2011, provided that that person keeps records showing the correlation between both batch numbers.
71.
As a reminder, Annex I to Regulation No 547/2011 requires certain information to be included ‘clearly and indelibly’ on the packaging of plant protection products. According to paragraph 1(f) of that annex, that information includes ‘the formulation batch number and production date’. For the purposes of interpreting that provision, the same interpretative principles applied in the context of the first question must be employed in the present question. (
43
)
72.
As regards the literal interpretation, it should be noted, as a preliminary remark, that Regulation No 547/2011 does not contain any definition of the term ‘batch number’. That definition can be found nevertheless in other EU legislation relating to product safety, for instance in Implementing Regulation (EU) 2021/1280, (
44
) which provides that the term ‘batch’ must be understood as the ‘quantity of starting material, packaging material or product processed in a single process or series of processes, so that it is expected to be homogeneous’. (
45
) That regulation refers to the term ‘batch number’ as a ‘distinctive combination of numbers or letters that uniquely identifies a batch’. (
46
) Both definitions mirror the understanding of those terms in common language, so, as the Austrian Government rightly points out, they can be taken as a proper reference point for interpreting paragraph 1(f) of Annex I to that regulation.
73.
Concerning that latter provision, the mere circumstance that it requires the indication of ‘the formulation batch number’ of the plant protection product appears to exclude that that number can be replaced by a different reference. Furthermore, paragraph 1(f) of Annex I to Regulation No 547/2011 not only refers to the term ‘batch number’, but also sets out that the packaging of the plant protection product must show the ‘formulation batch number’, which forms a larger semantical unit.
74.
That provision thus establishes a link between, on the one hand, the batch number given by the manufacturer to a plant protection product and, on the other, the specific formulation of that product, that is, its concrete preparation or solution. (
47
) In turn, that link suggests that it is indeed the batch number allocated by the manufacturer of the plant protection product in question which is the sole reference that must appear on the packaging of that product, and not, for instance, a number chosen at the discretion of a parallel importer.
75.
Lastly, if account is taken of the fact that paragraph 1(f) of Annex I to Regulation No 547/2011 requires not only the ‘formulation batch number’ to be included on the packaging of plant protection products, but also of the ‘date of manufacture’ of that product, the need to retain the original references allocated by the manufacturer of the plant protection product becomes even more apparent.
76.
As already explained, Article 1 of Regulation No 547/2011 and the provisions of Annex I thereto must, by virtue of Article 52(7) of Regulation No 1107/2009, be applied ‘correspondingly’ to the parallel trade of plant protection products. However, by contrast to the analysis and conclusion that I propose to the Court vis-à-vis the first question in the present case, I think that the requirement regarding the original batch number does not need to be adapted in the context of the parallel trade of plant protection products when considering the general objectives of Regulation No 1107/2009 and Regulation No 547/2011.
77.
In that regard, I must point out that the aims pursued by the labelling requirement laid down in paragraph 1(f) of Annex I to Regulation No 547/2011, which are also consistent with the general objectives of Regulation No 1107/2009, (
48
) are to allow, first, the traceability of a product and, second, targeted checks. That is also the logic expressed by the guidance document published by the Commission concerning the parallel trade of plant protection products, (
49
) which establishes that the indication of the batch number must ‘facilitate inspections and traceability of parallel traded products’. (
50
)
78.
With respect specifically to those objectives, the formulation batch number allows the products grouped together in the same batch to be traced simply and efficiently. After all, all the products sharing the same batch number are presumed to have the same composition and features. Consequently, as the appellant submits, in the event of an anomaly in production, the products concerned can be withdrawn from the market in a targeted and immediate manner. At the same time, it ensures that only the units of that product whose batch number corresponds to the batch concerned are, in fact, withdrawn from the market.
79.
By contrast, that traceability would be undermined if a parallel importer were allowed to remove the original formulation batch number and replace it with a personal identification number. In that case, the original formulation batch number, which is the only relevant reference for traceability purposes, should first be determined by comparison with the internal records kept by the parallel importer and any withdrawal of a product from the market would become more complicated. In that regard, I would like to stress that, unlike information concerning the name and address of the holder of the authorisation, which is at the direct disposal of the competent authorities in the Member State of introduction, those authorities appear not to have direct access to information concerning the records established by the importer. Furthermore, the situation is worse for consumers, who do not have access to the parallel importer’s internal records and cannot therefore compare the batch referred to with his or her product.
80.
Concerning the objective of the inspections, it is clear that replacement of the original batch number would also make it more difficult to carry out targeted checks. Such checks relating to the placing of plant protection products on the market aim to ensure the correct, safe and harmonised application of the requirements laid down by Regulation No 1107/2009, (
51
) in order to ensure a high level of protection of human and animal health and the environment. Inasmuch as the competent authorities in the Member State of introduction would not have direct access to the records established by the parallel importer, such a check would be rendered more difficult, including in situations that are urgent.
81.
It follows from the previous considerations that a teleological interpretation, taking account of the objective of Regulation No 1107/2009 and Regulation No 547/2011 to ensure a high level of protection of both human and animal health and the environment, suggests that the original formulation batch number cannot be discarded from the packaging of a plant protection product and replaced by another reference, even if the parallel importer keeps records of the batch numbers and corresponding reference.
82.
Concerning the objective of facilitating free movement, the respondent argues that the obligation for an importer to retain the original batch number allocated by the manufacturers of plant protection products could generate a risk of abuse by the latter. In essence, the respondent claims that, if the origin of the parallel-traded products could be traced by those manufacturers, they could easily hinder parallel trade by restricting, by themselves or in agreement with the distributors in the Member State of origin, the provision of those products to the importer. That would ultimately result in the partitioning of the EU market.
83.
However, in that regard, I would briefly point out that any abusive conduct by a manufacturer of a plant protection product, in the terms described by the respondent – whether in the Member State of origin or in the Member State of introduction – must be addressed by the appropriate means established by EU or national law, for instance Article 101 or Article 102 TFEU, which are in fact cited by the respondent in its observations. Such risk should certainly not be avoided at the cost of the objective of ensuring a high level of protection of both human and animal health and the environment, by rendering it more difficult to trace the product concerned and carry out the targeted checks incumbent on the competent authorities, as explained in points 77 to 81 above.
84.
In the light of the foregoing, I must conclude that Article 1 of Regulation No 547/2011, read in conjunction with paragraph 1(f) of Annex I thereto, must be interpreted as meaning that an importer who introduces a plant protection product into a Member State, on the basis of a parallel trade permit, is obliged to keep the formulation batch number initially allocated by the manufacturer on the label on that product and cannot replace it with its own reference, even if that importer keeps records showing the correlation between both batch numbers. Moreover, inasmuch as a national provision could allow such replacement, it should be considered, in my view, as incompatible with EU law.
V. Conclusion
85.
On the basis of the analysis set out above, I propose that the Court answer the two questions referred by the Hanseatisches Oberlandesgericht Hamburg (Higher Regional Court, Hamburg, Germany) as follows:
(1)
Article 1 of Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products, read in combination with paragraph 1(b) of Annex I thereto,
must be interpreted as meaning that an importer who introduces a plant protection product in a Member State, on the basis of a parallel trade permit, may replace the name and address of the holder of the authorisation in the Member State of origin with its own on the label of that product.
(2)
Article 1 of Regulation No 547/2011, read in combination with paragraph 1(f) of Annex I thereto,
must be interpreted as meaning that an importer who introduces a plant protection product in a Member State, on the basis of a parallel trade permit, is obliged to keep the formulation batch number initially allocated by the manufacturer on the label on that product and cannot replace it with its own reference, even if that importer keeps records showing the correlation between both batch numbers. Inasmuch as a national provision could allow such replacement, that provision is incompatible with EU law.
(
1
)	Original language: English.
(
2
)	Commission Regulation of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products (OJ 2011 L 155, p. 176).
(
3
)	Regulation 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).
(
4
)	Directive of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ 1999 L 200, p. 1).
(
5
)	Regulation 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 2008 L 353, p. 1).
(
6
)	See recital 9 of Regulation No 1107/2009.
(
7
)	Article 33(1) of Regulation No 1107/2009.
(
8
)	See Article 28(1) of Regulation No 1107/2009. See also Chapter III, Section 1, Subsection 2 of Regulation No 1107/2009 under the heading ‘Procedure’, in particular Article 36 thereof.
(
9
)	Article 33(3)(g) of Regulation No 1107/2009.
(
10
)	Article 60 of Regulation No 1272/2008.
(
11
)	See also recital 42 of Regulation No 1107/2009.
(
12
)	According to Article 3(10) and (24) of Regulation No 1107/2009, the term ‘holder of the authorisation’ is to be understood as the natural or legal person holding an authorisation of a plant protection product, that is to say, the administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory.
(
13
)	Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).
(
14
)	Article 83 of Regulation No 1107/2009.
(
15
)	Judgment of 11 March 1999 (C‑100/96, EU:C:1999:129).
(
16
)	Ibid. (paragraphs 29 to 34). See also judgment of 21 February 2008, Commission v France (C‑201/06, EU:C:2008:104, paragraph 34).
(
17
)	Judgment of 8 November 2007, Escalier and Bonnarel (C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 39 et seq.).
(
18
)	See recitals 9 and 31 of Regulation No 1107/2009.
(
19
)	Article 52(1), (3) and (9) of Regulation No 1107/2009.
(
20
)	See recital 31 of Regulation No 1107/2009 and Article 52(3) and (9) of that regulation.
(
21
)	See, inter alia, judgment of 7 June 2018, Scotch Whisky Association (C‑44/17, EU:C:2018:415, paragraph 27).
(
22
)	See point 36 above.
(
23
)	The term ‘correspondingly’ is commonly defined as ‘in a way that is similar to’. See inter alia the definition of the Cambridge Dictionary, available at https://dictionary.cambridge.org/dictionary/english/correspondingly.
(
24
)	See, to that effect, the French and the Latvian versions of Article 52(7) of Regulation No 1107/2009, which respectively use the term ‘mutatis mutandis’ and the term ‘attiecīgi piemēro’.
(
25
)	See footnotes 8 and 12 to this Opinion.
(
26
)	Article 52(2) and (3) of Regulation No 1107/2009. That simplified procedure does not comprise an evaluation of the substantial requirements established in Article 29 of Regulation No 1107/2009, which is, in my view, one of the reasons that explain the differentiation in the use of the terms ‘authorisation’ and ‘permit’ in Article 28 and Article 52 of Regulation No 1107/2009 respectively.
(
27
)	Judgment of 4 March 2021 (C‑912/19, EU:C:2021:173).
(
28
)	Ibid. (paragraph 29). See also judgment of 8 November 2007, Escalier and Bonnarel (C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 42).
(
29
)	See, in that regard, Article 28(1) and (2)(e) of Regulation No 1107/2009, which makes it clear that the purpose of both measures is to allow the placing on the market of a plant protection product.
(
30
)	See also point 38 above.
(
31
)	For the sake of completeness, I would briefly add that a situation of parallel trade does not fall within the scope of the second part of the sentence of paragraph 1(b) of Annex I to Regulation No 547/2011. Under that provision, in addition to the name and address of the holder of the authorisation, reference must also be made, if different, to the name and address of the person responsible for the packaging and the final labelling of the plant protection product. That part of the sentence of paragraph 1(b) of Annex I to Regulation No 547/2011 covers wholesalers to whom the holder of the authorisation sells products provided that they themselves package the products. Given that wholesalers are not subject to an authorisation procedure, they are required to be mentioned as the persons responsible for the packaging and final labelling of the plant protection product, in addition to the person authorised for placing it on the market.
(
32
)	As indicated in point 18 of the present Opinion, the reference to Directive 1999/45 in Article 65 of Regulation No 1107/2009 must be currently understood as referring to Regulation No 1272/2008, which repealed and replaced that directive.
(
33
)	See also recital 18 of Regulation No 1272/2008.
(
34
)	See also recital 42 of Regulation No 1107/2009, referring specifically to the objectives of the labelling requirements set out in that regulation.
(
35
)	See, for instance, judgment of 4 March 2021, Agrimotion (C‑912/19, EU:C:2021:173, paragraph 33).
(
36
)	See, in that regard, Article 31 of Regulation No 1107/2009, under the heading ‘Contents of authorisations’, in particular paragraphs 2, 3 and 4. See also Article 36(3) of that regulation.
(
37
)	See recital 45 and Chapter VIII of Regulation No 1107/2009, headed ‘Controls’.
(
38
)	Article 52(11) of Regulation No 1107/2009 sets out the obligation for Member State authorities to make publicly available the information about parallel trade permits.
(
39
)	As the respondent rightly notes, the holder of the parallel trade permit is responsible, in particular, for providing the ‘safety data sheet’ for the parallel-traded plant protection product, which is of utmost relevance if a consumer is poisoned by the product. See Article 31(1)(a) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45 and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1), as subsequently amended, read in combination with Article 18(1) of Regulation No 1272/2008.
(
40
)	See Article 36(3) of Regulation No 1107/2009, which allows Member States to impose stricter requirements and conditions for the application of a plant protection product under national risk mitigation measures.
(
41
)	See Article 44(4) of Regulation No 1107/2009.
(
42
)	See, in that vein, judgment of 14 November 2019, Vaselife International and Chrysal International (C‑445/18, EU:C:2019:968, paragraph 54).
(
43
)	See point 43 above.
(
44
)	Commission Implementing Regulation of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ 2021 L 279, p. 1).
(
45
)	Article 2(m) of Implementing Regulation 2021/1280.
(
46
)	Article 2(p) of Implementing Regulation 2021/1280.
(
47
)	Article 3(3) of Regulation No 1107/2009 provides that the term ‘preparations’ means ‘mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant’. There is greater linguistic correspondence in the French version of that provision, which refers to the term ‘préparations’, on the one hand, and the French version of paragraph 1(f) of Annex I to Regulation No 547/2011, on the other, that refers to ‘le numéro de lot et la date de fabrication de la
préparation’, that is to say, to ‘the batch number and production date of the preparation’.
(
48
)	See point 58 above.
(
49
)	Guidance document concerning the parallel trade of plant protection products, SANCO/10524/2012, 14.7.2015 (version 5.2).
(
50
)	Ibid. (point 4.4.1).
(
51
)	See footnote 37 above.