Key Benefits:
Publics concerned: (i) holders and applicants for marketing authorizations and for parallel trade permits of phytopharmaceutical and adjuvant products, (ii) users of these products.
Subject: This order amends several articles and the annexes to the Order of March 26, 2014.
Entry into force: the text comes into force on the day after its publication in the Official Journal of the French Republic.
Notice: This order takes into account the modifications made necessary by the transfer to ANES of the authorization decisions to place on the market of phytopharmaceutical products (articles 2 and 5 of this Order) and clarifies the drafting of Article 3 of the original text (Article 3). It extends the period for updating the labels of phytopharmaceutical products following any publication of a new leaflet in the national catalogue of phytopharmaceutical uses (Article 4). Finally, it provides for amendments to annexes 1 and 2 to the original text (arts. 6 and 7).
References: This Order is made pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing on the market of phytopharmaceutical products andArticle D. 253-8, paragraph II, rural code and maritime fisheries. These texts are available on the website Légifrance (http://www.legifrance.gouv.fr).
Minister of Agriculture, Agri-Food and Forestry, Government Spokesperson,
Having regard to Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the marketing of phytopharmaceutical products and repealing Directives 79/117/EEC and 91/414/EEC, including Article 31;
Considering Regulation (EU) No. 547/2011 of 8 June 2011 implementing Regulation (EC) No. 1107/2009 of the European Parliament and the Council concerning the labelling requirements of phytopharmaceutical products;
Vu le Rural and Maritime Fisheries Code (Legislative Party)including chapter III of title V of Book II and its article D. 253-8;
In view of the March 26, 2014 decision on the implementation of the National Catalogue of Phytopharmaceutical Uses referred to in market authorization and parallel trade permits for phytopharmaceuticals and adjuvants,
Stop it!
The above-mentioned decision of March 26, 2014 is amended in accordance with sections 2 to 7 below.
Paragraph II of Article 2 is replaced by the following provisions:
"II.-When the requested use is not included in the catalogue, the petitioner reports it to the National Health Safety Agency for Food, Environment and Labour at the time of filing the MMA application. The creation of the said use will only intervene if an AMM is issued."
Section 3 is replaced by the following:
"Art. 3.-I.-All MMA and permit decisions for use in a “reference” culture are valid for the same use on “related” crops, following the correspondence indicated in Appendix 1 to this Order, unless otherwise stated in the decisions and subject to the specific recommendations indicated on the label.
II.-MMA and permit decisions in force on April 1, 2014 for use affected by an amendment are valid for the new language of use, following the correspondence set out in Appendix 2 to this Order, unless otherwise set out in the decisions and subject to the specific recommendations indicated on the label. »
Section 4 is replaced by the following:
"Art. 4.-I.-Packs of products whose first bet on the market takes place within eighteen months of the publication of a new record of the catalogue can be distributed and used until stock is exhausted, without the obligation to update the labels under this new notice.
II.- Packages of products whose first placing on the market exceeds this period of eighteen months must be labelled taking into account this new notice. »
In section 5, the words "of the ministry responsible for agriculture" are deleted.
Appendix 1 is amended as follows:
1° The rows in the table corresponding to the reference crops "Colza" and "Tac" are deleted.
2° The rows of the table corresponding to the reference crops "Céréales", "Balls herbs", "Walks and peas (fresh)", "Infusions (dried)", "Oignon", "Pipe", "Pipe", "Gift-graine-PPAMC, floral and shelves" are replaced by the lines in Appendix 1 to this Order.
Appendix 2 is amended as follows:
1° The lines of the table listed in Schedule 2 to this Order are deleted (1).
2° The lines of the table listed in Appendix 3 to this Order are added (1).
3° In the column "new wording of use", the words: "fished peas" and "General Treatments* Trt Appat* Campagnols are replaced by the words "fresh peas" and "General Treatments* Trt Appat* Small rodents".
The Chief Food Officer is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
Annex 1
LINE VISED TO ARTICLE 6 (2O) MODIFIED IN THE WORLD TABLE FOR WMA AND PERMISSION DECISIONS
Cereal | Avoine, wheat, barley, rye, buckwheat, corn, millet, moha, sorghum, rice |
Fines herbs | Alloyed plants including chives Apiaceous plants including aneth, parsley, deer, fennel leaves, angelic, carvi Steady plants with tarragon, stevia Laminated plants including basil, thyme, sage, sine, oregano, marjolaine, hysope, mint Other condimentary plants, freshly consumed herbs, edible flowers and non-food PPAM |
Non-fished peas (fresh) | Green beans, net beans, Spanish beans, cut beans, dolic, soy beans, peas eat all |
Infusions (dried) | Plants or parts of dried infusion plants (flowers, leaves, roots) and non-food HIPCs |
Onion | Onion, garlic, shallot and ornamental bulbs |
Pavot | Pavot, eyelet, executioner, chenvis, seed yards, onagre, carthame, sesame, ricin as well as non-food PPAM |
Pear | Pear, spring onion, chives and other green onions |
Grain-PPAMC, floral and shelves | Any plant intended for the production of seeds of PPAMC, floral or pottery |
Done on December 2, 2015.
For the Minister and by delegation:
The Chief Food Officer,
P. Dehaumont