FAQs related to Regulation (EU) 2019/1009
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FAQs related to Regulation (EU) 2019/1009 | Ed. July 2022
ID 8863 | 18.07.2022 / Update Edition July 2022
FAQs related to Regulation (EU) 2019/1009 on fertilising products (the ‘Fertilising Products Regulation’)
1. What is a fertilising product?
A fertilising product is a substance, mixture, micro-organism or any other material which:
- is applied on plants or their rhizosphere or on mushrooms or their mycosphere,
- or constitutes the rhizosphere or mycosphere, either on its own or mixed with another material,
- and has as a purpose to provide plants or mushrooms with nutrient or improve their nutrition efficiency.
Fertilising products include fertilisers (which provide plants with nutrients), but also other categories of products (such as inhibitors, liming materials or growing media).
For more details on the products concerned, see the question “What is a product function category?”.
2. What is an EU fertilising product?
An EU fertilising product is a fertilising product which is CE marked when made available on the market.
A manufacturer is allowed to CE mark a fertilising product only if it:
- meets the requirements for the relevant product function category;
- meets the requirements for the relevant component material category or categories; and
- is labelled in accordance with the labelling requirements set out in the new rules.
3. Can manufacturers still place on the market fertilising products under national legislation?
Yes. Once the new rules of the Fertilising Products Regulation apply, as of 15 July 2022, the manufacturers have the possibility to choose between two options:
- Either to apply the Fertilising Products Regulation and affix the CE mark to their products; thus, these products move freely in the single market, or
- To follow the rules set at national level in one Member State and, if they intend to place their products on the market in another Member State, they have to follow the mutual recognition rules.
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1. The scope of the FPR
1.1 What is a fertilising product?
1.2 What is an EU fertilising product?
1.3 Does the FPR cover fertilising products containing substances or microorganisms which have a pesticide effect, such as copper compounds or calcium cyanamide?
1.4 Are organic fertilisers in the meaning of the ABPR covered by the FPR?
1.5 Is an organic fertiliser or an organic soil improver as set out in the FPR allowed to be used in organic farming production?
1.6 Does the FPR cover fertilising products for seed treatment?
1.7 Does the FPR change the rules concerning the use of processed manure under the Nitrates Directive?
2. Optional harmonisation
2.1 Does the FPR replace the existing national legislations? Can fertilising products still be placed on the market based on national legislation alone?
2.2 If the fertilising product meets the requirements of national legislation, can the manufacturer indicate reference to national legislation on the label of the CE marked fertilising product?
3.1 The obligation to keep the declaration of conformity and the technical documentation for 5 years after placing the product on the market
3.1.1 As of which date is this period of 5 years calculated for a production series of identical products?
3.1.2 How can manufacturers prove that a product was placed on the market more than 5 years ago?
3.2 A company repackages fertilising products already marketed by the original manufacturer, and gives them its own name and logo and then sells on the market. Is this company always considered a manufacturer for the purpose of the FPR? If so, how can it obtain information about the design and production process to carry out the relevant conformity assessment procedure?
3.3 What traceability elements do manufacturers have to include on the packaging?
4.1 Does the FPR change the obligations of distributors comparing to the current rules?
5. Notified Bodies
5.1 What is a notified body?
5.2 What conditions does a conformity assessment body have to fulfil in order to become a notified body under the FPR? Can a private entity be a notified body?
5.3 What procedure does a conformity assessment body have to follow to ask the notification under the FPR?
5.4 Does a conformity assessment body have to be able to perform conformity assessment for all types of EU fertilising products in order to become a notified body?
5.5 How is the Commission planning to ensure the coordination and cooperation between notified bodied for the purposes of the FPR?
5.6 Do manufacturers have to revert to a notified body established in the same EU country where they are registered or where they produce the products?
6. Transitional period
6.1 When will the FPR start to apply?
6.2 After 16 July 2022, is an economic operator allowed to make available on the market products designated “EC Fertilisers” under the current rules?
6.3 Is it only distributors that are allowed, after 16 July 2022, to make available on the market products designated “EC fertilisers” under the current rules?
6.4 How can an economic operator prove that fertilisers designated ‘EC Fertilisers’ under the current rules have been placed on the market before 16 July 2022?
6.5 Before 16 July 2022, is an economic operator allowed to make EU fertilising products available on the market pursuant to the FPR?
6.6 Are manufacturers allowed to start the conformity assessment of their products before the application date of the FPR?
7. Annex I – Product Function Category (PFC)
7.1 What is the function of an EU fertilising product?
7.2 When a product could comply with different product function categories in the FPR, is the manufacturer free to choose the product function for that EU fertilising product?
7.3 May an EU fertilising product belong to two product function categories at the same time?
7.4 What is the maximum content of organic carbon (Corg) that an inorganic fertiliser may contain?
7.5 How to categorise an inorganic fertiliser that contains only secondary nutrients?
7.6 What is a fertilising product blend?
7.7 What are the obligations of a blender under the FPR?
7.8 Is a blender of two EU fertilising products allowed to place the blend on the market without the CE mark, under national rules?
7.9 When should the requirements for pathogens in fertilising product blends be checked?
What are the consequences of regrowth of pathogens in normal conditions during storage or in the distribution chain?
8. Annex II – Component Material Category (CMC)
8.1 What may EU fertilising products contain/consist of?
8.2 How does a manufacturer demonstrate that the product placed on the market consists “solely” of CMCs? Is the manufacturer required to produce a list of all CMCs present in the final product indicating the % of each one?
8.3 Can a component material fit under two CMCs at the same time (e.g. both CMC 1 (virgin substance) and 11 (by-products within the meaning of WFD), or both CMC 6 (food industry byproducts) and 11)? If yes, who decides what CMC to rely on?
8.4 Is it possible to place on the market in an EU country, EU fertilising products containing compost or digestate even if the compost or digestate therein do not meet the national end-of waste criteria?
8.5 If raw materials taken from earth/ground are used as raw material and remain in unreacted
form in the fertilising product, then is it necessary to do a REACH registration for that material for
the purpose of compliance with CMC 1?
8.6 Does the obligation for REACH registration in CMC 1 apply for preservative agents incorporated in fertilising products that are already approved under the Biocidal Products Regulation?
8.7 Do technical additives belonging to, for instance, CMC 1, have to be REACH registered with
a dossier containing a chemical safety report covering the use as fertilising products, given that they are not themselves fertilising products?
8.8 Is it possible for the manufacturers of EU fertilising products to rely on the REACH registration done by other operators for a recovered substance?
8.9 A substance or mixture belonging to CMC 1 may contain detectable traces of unreacted ingredients or processing agents. Should these impurities be separately considered as components of the final composition of fertilising product?
8.10 How to comply with the REACH registration obligations in case of substances which evolve over time?
8.11 Can ammonium sulphate as a by-product from caprolactam or coke oven production be classified as a component material belonging to CMC 1 (Virgin material substances and mixtures)?
8.12 Does the CMC 2 (Plants, plant parts or plant extracts) include the seaweed extracted with alkaline solution?
8.13 If a material belonging to CMC 1 is produced through intentional chemical reaction between two chemical substances (‘precursors’), at which point in the manufacturing process must the chemical substance(s) comply with the requirements of the FPR? Is it the precursors or the reaction product that need to correspond with such requirements?
8.14 Are manufacturers allowed to use derived products from animal by-products, such as processed manure, in EU fertilising products?
8.15 Are manufacturers allowed to use plant/plant parts grown for the production of biogas in compost or digestate other than fresh crop digestate?
9. Annex III – Labelling requirements
9.1 Can a manufacturer use green or any other coloured pictogram to provide product information on the label of an EU fertilising product?
9.2 How should a manufacturer label the nutrients content of a fertilising product blend if the content of some forms of the nutrients vary over time, like in the case of blending a growing medium with an inorganic fertiliser?
9.3 How to declare the nutrients content in blends composed of a fertiliser and a plant biostimulant?
10. Annex IV - Conformity assessment
10.1 What conformity assessment procedure do the manufacturers have to follow?
10.2 Can conformity assessment be done even if harmonised standards are not adopted?
10.3 If a manufacturer subcontracts certain parts of the production process to other company, using the original production process of the manufacturer, is it necessary to do a different conformity assessment?
10.4 Who performs the conformity assessment in case the product is produced by a manufacturer from a third country and imported in the EU?
10.5 What is expected by ‘adequate analysis and assessment of the risk(s) to be included in the technical documentation’?
10.6 Does technical documentation have to be physically available for the inspection, or can it be accessible through digital means?
10.7 How should the manufacturer perform the conformity assessment of component materials belonging to, for instance, CMC 1, bought from third parties and provide information about their origin or manufacturing?
10.8 What does ‘Modules B + C’ mean?
10.9 What is an EU-type certificate issued by a notified body and what is its expiry date?
10.10 For ammonium nitrate fertilisers of high nitrogen content, does the manufacturer or the notified body perform the detonation resistance test and the oil retention test?
10.11 What does Module D1 mean?
10.12 The reports of what types of accidents or incidents should be included in the quality management documentation in Module D1?
10.13 Can national authorities require that Module D1 is used for a fertilising product that only requires Module A, e.g., an organic fertiliser?
|FAQs related to Regulation EU 2019_1009.pdf
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Tags: Marcatura CE Abbonati Marcatura CE Regolamento fertilizzanti