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FRENCH REPUBLIC Ministry of Agriculture and Food
10 April 2020

Order of […]
Official Journal of the French Republic (JORF) No 0088 of 10 April 2020

on the authorisation conditions for plant protection products for the ‘amateur’ range of uses
Text No 14

NOR:
Order of 6 April 2020 on the conditions for authorising a plant protection product for the ‘amateur’ range of uses

Groups concerned: holders of and applicants for marketing authorisations and parallel trade permits for plant protection products referred to in Article L253-1 of the Rural and Maritime Fishing Code for the ‘amateur’ range of uses.
NOR: AGRG1932122A

ELI:https://www.legifrance.gouv.fr/eli/arrete/2020/4/6/AGRG1932122A/jo/texte

Public concerned: holders of and applicants for marketing authorisations and parallel trade permits for plant protection products referred to in Article L253-1 of the Rural and Maritime Fishing Code for the ‘amateur’ range of uses.

Purpose: to update the authorisation conditions for plant protection products for the ‘amateur’ range of uses.

Entry into force: the text shall enter into force on the day after its publication.

Notice: this Order strengthens the requirements for the authorisation of plant protection products for the ‘amateur’ range of uses in order to guarantee greater safety in their use. In particular, it adds certain public health or environmental hazard warnings to the criteria for issuing a marketing authorisation or parallel trade permit for a product intended for non-professional users. The Order specifies the specific labelling and packaging requirements for these products in order to ensure minimum exposure conditions for the user and preserve the environment. Finally, it lays down the procedures for bringing marketing authorisations and parallel trade permits for the ‘amateur’ range of uses in force into line with the new authorisation conditions for these products.
Notice: this Order strengthens the requirements for the authorisation of plant protection products for the ‘amateur’ range of uses in order to guarantee greater safety in their use. The requirements are being strengthened in the context of the entry into force of Act No 2014-110 of 6 February 2014 which aimed to better regulate the use of plant protection products on national territory, and which prohibited the placing on the market, distribution, use and possession of synthetic plant protection products for non-professional use from 1 January 2019. In particular, the Order adds certain public health or environmental hazard warnings to the criteria for issuing a marketing authorisation or parallel trade permit for a product intended for non-professional users. It specifies the specific labelling and packaging requirements for these products in order to ensure minimum exposure conditions for the user and preserve the environment. Finally, it lays down the procedures for bringing marketing authorisations and parallel trade permits for the ‘amateur’ range of uses in force into line with the new authorisation conditions for these products.

References: this Order is issued pursuant to Article L253-7, D253-8 and R253-45 of the Rural and Maritime Fishing Code. It may be consulted on the Legifrance website (http://www.legifrance.gouv.fr).
References: this Order is issued pursuant to Article L253-7, D253-8 and R253-45 of the Rural and Maritime Fishing Code. It may be consulted on the Légifrance website (http://legifrance.gouv.fr).

The Ministre d’Etat, Minister the Ecological and Inclusive Transition, the Minister for Solidarity and Health, the Minister for Economy and Finance and the Minister for Agriculture and Food,
The Minister for the Ecological and Inclusive Transition, the Minister for Solidarity and Health, the Minister for the Economy and Finance and the Minister for Agriculture and Food,

Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, as amended, 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;
Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009, as amended, concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;
mixtures, as amended, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006;

Having regard to Commission Regulation (EU) No 547/2011 of 8 June 2011, as amended, implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council on the labelling requirements for plant protection products;
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009, as amended, concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;

Having regard to Directive (EU) No 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services;
Having regard to Commission Regulation (EU) No 547/2011 of 8 June 2011, as amended, implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products;

Having regard to the Rural and Maritime Fishing Code, in particular Articles L253-7, D253-8 and R253-45 thereof;
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services;

Having regard to notification No 2019/ of to the European Commission;
Having regard to the Rural and Maritime Fishing Code, in particular Articles L253-1, L253-7, D253-8 and R253-45 thereof;

Having regard to the public consultation held from to 2019, in accordance with Article L123-19-1 of the Environmental Code,
Having regard to Notification No 2019/282/F of 14 June 2019 to the European Commission;

Having regard to the public consultation held from Friday 12 July to Monday 5 August 2019 in accordance with Article L123-19-1 of the Environmental Code,

Hereby order:

Article 1

Marketing authorisations or parallel trade permits for the ‘amateur’ range of uses shall be issued for plant protection products referred to in Article L253-1 of the Rural and Maritime Fishing Code that belong to the categories mentioned in IV of Article L253-7 of the same Code, if they meet the requirements of Articles 2 to 4.
Marketing authorisations or parallel trade permits for the ‘amateur’ range of uses shall be issued for plant protection products referred to in Article L253-1 of the aforementioned Rural and Maritime Fishing Code that belong to one of the categories mentioned in IV of Article L253-7 of the same Code if they meet the requirements of Articles 2 to 4.

These plant protection products are hereinafter referred to as ‘products’.


a) active substances considered to have endocrine disrupting effects in accordance with Annex II to Regulation (EC) No 1107/2009;

b) active substances corresponding to one or more of the following hazard statements according to the classification in Regulation (EC) No 1272/2008:
b) active substances marked with one or more of the following hazard statements as laid out in the aforementioned Regulation (EC) No 1272/2008:

H340, H341, H350, H350i, H351, H360, H360D, H360F, H360FD, H360Df, H360Fd, H361, H361d, H361f, H361fd, H362, H370, H371, H372, H373;

c) active substances that are persistent, bioaccumulative and toxic, in accordance with the criteria set out in Annex II to Regulation (EC) No 1107/2009;
c) active substances that are persistent, bioaccumulative and toxic, in accordance with the criteria set out in Annex II to the aforementioned Regulation (EC) No 1107/2009;

d) active substances that are very persistent and very bioaccumulative in accordance with the criteria set out in Annex II to Regulation (EC) No 1107/2009;
d) active substances that are very persistent and very bioaccumulative in accordance with the criteria set out in Annex II to the aforementioned Regulation (EC) No 1107/2009;

e) active substances that are persistent organic pollutants according to the criteria set out in Annex II to Regulation (EC) No 1107/2009.
e) active substances that are persistent organic pollutants in accordance with the criteria set out in Annex II to the aforementioned Regulation (EC) No 1107/2009.

2. Products corresponding to one or more of the following hazard statements according to the classification scheme in Regulation (EC) No 1272/2008:
2. Products marked with one or more of the following hazard statements as laid out in the aforementioned Regulation (EC) No 1272/2008:

H200, H201, H202, H203, H204, H205, H300, H301, H304, H310, H311, H314, H317, H318, H330, H331, H334, H340, H341, H350, H350i, H351, H360, H360D, H360F, H360FD, H360Df, H360Fd, H361, H361d, H361f, H361fd, H362, H370, H371, H372, H373.
H200, H201, H202, H203, H204, H205, H300, H301, H310, H311, H314, H317, H318, H330, H331, H334, H340, H341, H350, H350i, H351, H360, H360D, H360F, H360FD, H360Df, H360Fd, H361, H361d, H361f, H361fd, H362, H370, H371, H372, H373.

3. Products in the form of powder for dusting;

4. Products in the form of wettable powder with the exception of single-dose packages that exclude contact with the product.
4. Products in the form of wettable powder, with the exception of single-dose packages or any other dosage system that excludes contact between the user and the product.

Article 3

The inner and outer packaging of products shall ensure minimal exposure conditions for people and the environment. The outer packaging shall be resealable, except in the case of single-dose inner packaging.
Without prejudice to the provisions of the aforementioned Regulation (EC) No 1272/2008, product packages and packaging shall ensure the minimum exposure conditions for people and the environment. With the exception of single-dose packages, packaging shall be airtight.

Article 4
Article 4

Without prejudice to the provisions of Regulations (EC) No 1272/2008 and (EU) No 547/2011, the packaging or labelling of products in the 'amateur' range of uses shall meet the following conditions:
Without prejudice to the provisions of the aforementioned Regulations (EC) No 1272/2008 and (EU) No 547/2011, the packaging or labelling of products in the 'amateur' range of uses shall meet the following conditions:

1. It shall include the following information, presented in a legible and explicit way for non-professional users:
1. It shall include the following information, presented in a legible and explicit manner for non-professional users:

a) the precautionary statements ‘Keep out of the reach of children.’ and ‘Do not eat, drink or smoke while using the product. ’;
a) the precautionary statements ‘Keep out of the reach of children’ and ‘When using this product do not eat, drink or smoke’;

b) specific precautions for use, if any;

c) the uses of the product, as stated in the marketing authorisation or the parallel trade permit, presented on the same face as the trade name;
c) the uses of the product, as stated in the marketing authorisation decision or the parallel trade permit, presented on the same face as the trade name;

d) the dosage, indicated in g or ml/l, in g or ml/5 l, in g or ml/m2, or in g or ml/10 m2;
d) the doses to be applied, indicated in g or ml/l, in g or ml/5 l, in g or ml/m2, in g or ml/10 m2, or in any dose unit referred to in the marketing authorisation decision or the parallel trade permit;

e) the re-entry period set in the marketing authorisation or parallel trade permit. If no indication is given in the authorisation or permit, the packaging or labelling shall include the words: ‘wait until the treated area has dried completely before re-entering’;
e) the re-entry period set in the marketing authorisation or parallel trade permit. If no indication is given in the authorisation or permit, the packaging or labelling for products applied in liquid form shall include the words: ‘wait until the treated area has dried completely before re-entering’;

f) the pre-harvest interval set in the marketing authorisation or parallel trade permit. If no indication is given in the authorisation or permit, the period indicated shall not be less than three days;

g) instructions for the disposal of products and empty packaging, so as to avoid any discharge into the sewer or into the environment.

2. Any other wording or any pictograms relating to procedures or advice for use, such as the recommended treatment period or frequency of use, shall have been approved in advance by the National Agency for Food, Environmental and Occupational Health and Safety in order to appear on the packaging or labelling.

3. It shall not contain any potentially misleading information, in the form of texts or illustrations, regarding the effectiveness of the product or possible risks to human or animal health or the environment, such as the terms ‘non-toxic’, ‘Non-dangerous’ or ‘safe’.
2. Any other wording or any pictograms relating to procedures or advice for use, such as the recommended treatment period or frequency of use, shall have been authorised in advance by the National Agency for Food, Environmental and Occupational Health and Safety in order to appear on the packaging or labelling.

Article 5

The National Agency for Food, Environmental and Occupational Health and Safety shall, on the basis of the information available to it, withdraw marketing authorisations and parallel trade permits for products in the ‘amateur’ range of uses covered by the prohibition of paragraph III of Article L253-7 within six months of the date of entry into force of this Order.
The National Agency for Food, Environmental and Occupational Health and Safety shall, on the basis of the information available to it, withdraw marketing authorisations and parallel trade permits for products in the ‘amateur’ range of uses covered by the prohibition of paragraph III of Article L253-7 of the Rural and Maritime Fishing Code within six months of the date of entry into force of this Order.

Article 6

The Order of 30 December 2010 prohibiting the use of certain plant protection products by non-professional users and the Order of 30 December 2010 on packaging requirements for plant protection products for use by non-professional users are hereby repealed.

Done on [date]
Article 7

This Order shall be published in the Official Journal of the French Republic.

Done on 6 April 2020.

The Minister for Agriculture and Food,

Didier GUILLAUME
For the Minister and by delegation:

The Ministre d’Etat, Minister for the Ecological and Inclusive Transition,
The Director-General for Food,

François DE RUGY
B. Ferreira

The Minister for the Ecological and Inclusive Transition,

For and on behalf of the Minister:

The Director-General for Risk Prevention,

C. Bourillet

The Minister for Solidarity and Health,

Agnès Buzyn
For the Minister and by delegation:

The Director-General for Health,

J. Salomon

The Minister for the Economy and Finance,

Bruno LE MAIRE
For the Minister and by delegation:

The Director-General for Competition Policy, Consumer Affairs and Fraud Control,

V. Beaumeunier