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Changes to harmonize EU fertilizer legislation: The new Regulation (EU) No. 2019/1009

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published on 11 November 2020 | Reading time approx. 10 minutes
  

The debate on climate protection and circular economy has a growing influence on EU fertiliser legislation. In addition to conventional fertilisers from mined or chemically produced materials, more climate-friendly fertilisers made from organic materials are increasingly being used. The new Regulation (EU) No 2019/1009 ensures a level playing field for all fertilising products, thus giving innovative companies better access to the internal market. This article addresses the most important changes for companies resulting from the new EU Fertiliser Regulation, including in particular the introduction of CE marking for fertilising products.

   

   

Overview and problem definition of the status quo of fertiliser legislation

Fertilisers are among products in respect of which strict rules may be necessary due to legitimate concerns about health, environment and quality. However, in addition to Regulation (EC) No. 2003/2003, a large patch­work of complicated and partially very different national provisions of fertiliser legislation has existed up to now. The efforts of the Member States to protect, in particular, the feed and food chain in the best possible manner repeatedly contradict the concrete enforcement of the free movement of goods and the associated principle of mutual recognition, which makes it difficult or even impossible, especially for innovative compa­nies, to access the market. Such products therefore have a competitive disadvantage, which is an obstacle to both innovation and investment in the circular economy. After the major problems of the existing legal framework first came to light during the ex post evaluation of Regulation (EC) No 2003/2003  in 2010, the Commission submitted a proposal for the adoption of a new fertiliser regulation on 17 March 2016 as part of the “Package on circular economy” with the aim of further harmonising EU fertiliser legislation. The reason behind was the fact that the Fertiliser Regulation being currently in force  has regulated market access for predomi­nantly conventional mineral/inorganic fertilisers, the production of which is associated with high energy consumption and CO2 emissions, while the organic fertilisers obtained in accordance with the circular economy – making up about half of the fertilisers on the market – have not been harmonised yet. Also harmful effects on soils and waters – and thus also on feed and food – as a result of contamination by fertilisers were not considered in the previous EU regulation at all.

 

New legal framework for fertilisers

The fertiliser sector contributes to the circular economy due to the increasingly progressive development of research, innovation and investment. Companies operating in the industry will have easier access to the innovative products market in the future and should already make themselves familiar with the upcoming changes. The previously applicable Regulation (EC) No 2003/2003 will be repealed with effect from 16 July 2022 and replaced by Regulation (EU) No 2019/1009 (hereinafter referred to as the “new EU Fertiliser Regulation”), which applies to CE marked fertilising products, so-called EU fertilising products. If they are in conformity with the harmonised safety, quality and labelling requirements regulated there, they can be sold freely throughout the EU and may no longer be hindered by product-related national measures and regulations, which is now expressly stipulated (Article 3 of the new Fertiliser Regulation). Thus, no Member State may demand additional marking elements for such EU fertilising products based on its national regulations, nor may national regulations result in EU fertilising products having to be changed in their composition. Placing of fertilisers on the market is still permitted under national fertiliser legislation, although in this case there may still be obstacles to the free movement of goods; the resulting problems can be solved by means of the principles on the free movement of goods (Articles 28-36 TFEU), the practical enforcement of which was strengthened by the entry into force of Regulation (EU) No 2019/515 in April 2020. The new EU Fertiliser Regulation thus pursues a model of optional harmonisation, which gives enterprises a certain freedom of choice.
 
The new regulation at EU level not only sets (uniform) limit values for contaminants and heavy metals in EU fertilising products (toxic contaminants such as cadmium in phosphate fertilisers), but also abolishes the well-known fertiliser types and replaces them with new product function categories (PFC). For the first time, the harmonised product categories include not only mineral/inorganic fertilisers but also organic and, in particular, recycled products used for fertilisation, so that their CE marking is possible. The advantage, is the associated presumption of conformity and thus free marketability throughout the EU. The new product group of biostimulants is also regulated. Biostimulants are types of fertilisers in the case of which plants’ natural nutrition processes are stimulated independently of the product’s nutrient content with the sole aim of improving characteristics of the plant (nutrient use efficiency, tolerance to abiotic stress, quality traits).  In addition, component material categories (CMC) are introduced, whose specific requirements must be met when EU fertilising products are placed on the market (Article 4(1) b) of the new EU Fertiliser Regulation). In accordance with Annex II to the Regulation, an EU fertilising product shall consist solely of component materials complying with the requirements of the CMCs listed in this Annex. Another important new regulation for enterprises is the clarification of the responsibilities of individual economic operators and a new definition of a manufacturer.
 
The new EU Fertiliser Regulation does not apply to animal by-products and plant protection products, because harmonised special rules already exist for these products (EC Regulations No 1069/2009  and No 1107/2009 ).

 

Obligations of economic operators and new definition of a manufacturer

The new EU Fertiliser Regulation introduces the term “economic operator”, which includes manufacturers, authorised representatives, importers and distributors (see Article 2(15) of the new EU Fertiliser Regulation) and defines their responsibilities and obligations in detail (Articles 6-12 of the new EU Fertiliser Regulation). Numerous obligations have been imposed in particular on manufacturers. ‘Manufacturer’ means a person who manufactures an EU fertilising product or has an EU fertilising product designed or manufactured, and markets that EU fertilising product under his or her name or trademark (Article 2(11) of the new EU Fertiliser Regu­la­tion).  In contrast to the previous Regulation (EC) No 2003/2003, other economic operators such as importers and distributors are not deemed to be manufacturers from the outset. However, if they decide to act as manufacturers of a product by marketing it under their own name/trademark, although they did not manu­facture or produce it themselves, or if they make changes to the product which may affect its conformity, these operators (importers/distributors) are also subject to the far-reaching manufacturer obligations (Article 10 of the new EU Fertiliser Regulation). In this context, it should be pointed out that the European Court of Justice has, in its case law, specified the characteristic of “marketing under one's own name” in more detail. For example, an economic operator markets a product under his own name when he places it in another packaging or changes the information on the packaging so that it no longer refers to the original manufacturer but only to himself. On the other hand, an economic operator who buys an EU fertilising product in one Member State after it has been placed on the market in the EU by the manufacturer and then resells it in another Member State under the name of the manufacturer, without altering the packaging or original presentation other than by affixing a sticker identifying him as the person responsible for placing it on the market, cannot be considered to be someone who markets the product under “his own name” (see ECJ judgments of 24/11/2016, C-662/15 and of 13/10/2016, C-277/15). The law does not explicitly state under which condition a modification that affects the conformity of a fertiliser is given. However, the principles laid down in the new Medical Devices Regulation (EU) 2017/745 (Art. 16 (2)) can be applied analogously: Such a modification does not already exist, for example, if the mandatory information is translated into the language of the country of marketing or if the outer packaging of the product is modified because this is necessary for marketing in a particular Member State, as long as the original integrity is not affected.
 
Irrespective of this, the obligations for importers and distributors are comprehensively regulated in Articles 8 and 9 of the new EU Fertiliser Regulation. The central idea is that only compliant EU fertilising products may be placed on the market. It is also important that importers and distributors are equally obliged to inform the market surveillance authorities (and possibly other economic operators involved) if a product presents a risk to human, animal or plant health, safety or the environment. These economic operators also have other obli­ga­tions, such as verifying whether the manufacturer has provided the necessary documentation and information. They must also ensure that storage and transport conditions do not compromise the compatibility of EU fertilising products with the new EU Fertiliser Regulation as long as the products fall within their area of responsibility. The obligations of the two economic operators also differ on a closer look, as the importer has more extensive obligations. It should be emphasised, for example, that the importer must provide its identi­fication data on the packaging of the EU fertilising product (or accompanying document).
 
Economic operators should take these obligations seriously and set up appropriate internal compliance systems to ensure and monitor their observance. Otherwise, not only civil law actions, but also administrative and possibly even criminal sanctions may be imposed.

   

Introduction of the CE marking for the new product function categories

As already mentioned, according to the new EU Fertiliser Regulation, EU fertilising products are classified into the so-called Product Function Categories (PFCs) (fertilisers, liming material, soil improvers, growing media, inhibitors, plant biostimulants and fertilising product blends), for which, according to Article 4 (1) a) in conjunction with Annexes I and III of the new EU Fertiliser Regulation, different safety and quality require­ments as well as general and product-related marking provisions should be taken into account in each case. In addition, specific requirements also apply to the so-called component material categories (CMC).
 
An “EU fertilising product” means according to the definition a fertilising product which is CE marked when made available on the market (Article 2 (2) of the new EU Fertiliser Regulation). The CE marking should be affixed by the manufacturer to the product (on each individual package or on the accompanying document in the case of unpackaged products) if the product complies with the requirements of the Regulation. The CE marking may only be used if the conformity assessment procedure within the meaning of Article 15 in con­junction with Annex IV of the new EU Fertiliser Regulation has been successfully completed. The assessment procedure to be applied depends on whether the product belongs to the PFC and CMC listed in Annexes I and II to the new EU Fertiliser Regulation. There are different stages (modules A, A1, B and C), which are explained in more detail in Part II of Annex IV to the new EU Fertiliser Regulation. Thus, for example, in the case of Module A (the so-called “internal production control”), the manufacturer is required to draw up a self-declaration on his sole responsibility, which shows that his EU fertilising products meet the requirements of the new EU Fertiliser Regulation. By contrast, module B (the so-called “EU type examination”) requires an examination of the technical design of an EU fertilising product by a conformity assessment body (notified body), which then certifies the compatibility of the product with the new EU Fertiliser Regulation. Conformity assessment bodies are accredited in Germany by the Federal Agency for Agriculture and Food (notifying authority since 16/04/2020).

 
Products that are allowed to be CE marked may be freely traded in the EU, which is an enormous advantage for enterprises operating throughout the EU.
 

Traceability and market surveillance

The new EU fertiliser regulation also increases the responsibility of all economic operators in terms of traceability and market surveillance. However, it should also be emphasised that they now also enjoy specific rights enshrined in the law, in particular consultation and participation rights. This enables economic operators to cooperate with the authorities in the procedures that concern them and to provide additional information.
 
A new obligation for all economic operators is that they must ensure the traceability of the EU fertilisers they market: at the request of the market surveillance authorities, they must be able to inform them from whom they have purchased a specific EU fertilising product and to whom they have supplied it (Article 12 of the new EU fertiliser regulation). The purpose of this novelty is to make it easier for market surveillance authorities to detect economic operators who have made non-compliant EU fertilising products available on the market. Companies concerned will thus be required in future to ensure that they have appropriate traceability systems in place.
 
In addition to the general provisions on market surveillance, which are laid down in Articles 16-29 of Regulation (EC) No. 765/2008, the new EU fertiliser regulation introduces in Article 38 a special procedure at national level for handling EU fertilising products which present a risk. It provides that, where there is sufficient reason to believe that an EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the market surveillance authorities of a Member State may verify the compatibility of the product concerned with the new EU fertiliser regulation and, if necessary, require the economic operator to take corrective action. This procedure also includes a coordination mechanism between EU Member States and the Commission for non-compliant EU fertilising products marketed throughout the EU.
 
In order to increase transparency and to reduce processing time, the new EU fertiliser regulation requires improving the safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States (Article 40 of the new EU fertiliser regulation).
 

End-of-waste status – how is it useful for enterprises?

The question about the end-of-waste status arises mainly because the new EU fertiliser regulation now covers organic fertilisers that are manufactured, among other things, from recycled biodegradable waste from the food industry or from non-animal agricultural by-products. The organic fertilisers from animal by-products that are also available on the market are, as mentioned above, explicitly excluded from the scope of the new EU fertiliser regulation (Article 1 (a)) of the new EU fertiliser regulation) and fall under Regulation (EC) No 1069/2009.
 
If an (organic) fertiliser bears the CE marking, it no longer constitutes waste (for the definition of waste see Directive 2008/98/EC ). This arises from Article 19 of the new EU fertiliser regulation. Conversely, it should be noted that the individual components (biodegradable waste) used for the manufacture of the finished product are not yet affected by the end-of-waste status, i.e. they continue to constitute waste.
 
The end-of-waste status of a product offers advantages to the enterprise that wants to market such product. In Germany, for example, fertilisers made from biodegradable waste continue to be regarded as waste even if they have been properly placed on the market under national law.  Such products continue to be subject to waste legislation until they are recovered according to their purpose. If, on the other hand, an enterprise decides to CE mark such products and market them as fertilisers, the finished product is not subject to waste legislation. This means that such a product is no longer subject to various obligations arising from waste law, such as the verification procedure, the use of the A-signs and restrictions on use.
 
The change is directly related to the European Commission's “end-of-waste criteria” for recycled materials. The European Commission's "Circular Economy Package” also aims to re-classify as products (i.e. as non-waste) such materials that have undergone a recycling process and fulfil certain general conditions applicable throughout the EU, thus simplifying and harmonising the legal framework for operators in the recycling sector. To that end, the end-of-waste status criteria were concretised, among other things, by the EU legislative package on circular economy which came into force on 04/07/2018.

 
The end-of-waste status will create an incentive for enterprises to invest in the development of fertilisers made from recycled materials. This is because, in addition to the fact that these products no longer fall under waste legislation, an innovative enterprise can also advertise the environmental friendliness of its fertilisers to an environmentally aware user. It should be noted, however, that the use of Green Claims is linked to certain requirements which must be strictly observed by companies.

 

The model of optional harmonisation – the enterprise has the choice

As a rule, national laws are replaced with European law and its harmonised product specifications. The legislator departs from this principle in the case of fertilisers, thus taking into account the fact that some markets for fertilising products are regionally very limited. For example, recital 5 reads: “This Regulation should therefore not apply to products which are not CE marked when made available on the market.” This means that enterprises have a choice: if they want to use their product to gain access to more than one national territory, they should apply for the CE marking and undergo the necessary conformity assessment procedure. They are no longer dependent on the mutual recognition principle. If, on the other hand, they do not seek to ensure conformity with EU rules, or if it is impossible or possible only to a limited extent to ensure such conformity, they will still have access to national markets.

 

Conclusion

On the one hand, the new EU fertiliser regulation ensures a level playing field for all EU fertilising products and, in addition, promotes the use of domestic secondary raw materials. Thus, a new market for recycled raw materials can be created, which in turn opens up new market opportunities for innovative companies. At the same time, a wider range of fertilisers can be made more easily available to farmers, thus reducing the negative impact of mineral fertilisers on soil and food.

   

Outlook

A wider choice of fertilisers can help make the manufacturing of feed and food products more cost- and resource-efficient in the future.

 
The new EU fertiliser regulation will not only have an impact on the fertiliser sector. Also private and public recycling companies will be able to add value to their production by contributing to the idea of environmentally friendly fertilisers. The new EU fertiliser regulation will also have an impact on the public authorities as it will reduce their workload if control mechanisms are fully or partially implemented at EU level. The extent to which the requirements of the new EU fertiliser regulation (in particular those concerning hygiene and minimum nutrient content) can be met at all by common composts and fermentation products has not been conclusively clarified, though. The practical application of the new EU fertiliser regulation will show whether improvements still need to be made at this point through delegated legal acts of the Commission to ensure that organic fertilising products actually enjoy easier market access thanks to the new regulation.

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