Regulation 2019/1009 - Rules on the making available on the market of EU fertilising products - Main contents

EN

Official Journal of the European Union

L 170/1

The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council (3), which almost exclusively covers fertilisers from mined or chemically produced, inorganic materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. Promoting increased use of recycled nutrients would further aid the development of the circular economy and allow a more resource-efficient general use of nutrients, while reducing Union dependency on nutrients from third countries. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

Certain products are being used in combination with fertilisers for the purpose of improving nutrition efficiency, with the beneficial effect of reducing the amount of fertilisers used and hence their environmental impact. In order to facilitate their free movement on the internal market, not only fertilisers, i.e. products intended to provide plants with nutrient, but also products intended to improve plants’ nutrition efficiency, should be covered by the harmonisation.

Regulation (EC) No 765/2008 of the European Parliament and of the Council (4) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. That Regulation should be applicable to products covered by this Regulation in order to ensure that products benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as human, animal and plant health, safety and the environment.

Decision No 768/2008/EC of the European Parliament and of the Council (5) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Regulation (EC) No 2003/2003 should therefore be replaced by this Regulation, drafted to the extent possible in accordance with those common principles and reference provisions.

Contrary to most other product harmonisation measures in Union law, Regulation (EC) No 2003/2003 does not prevent non-harmonised fertilisers from being made available on the internal market in accordance with national law and the general free movement rules of the Treaty on the Functioning of the European Union (TFEU). In view of the very local nature of certain product markets, this possibility should remain. Compliance with harmonised rules should therefore remain optional, and should be required only for products, intended to provide plants with nutrient or improve plants’ nutrition efficiency, which are CE marked when made available on the market. This Regulation should therefore not apply to products which are not CE marked when made available on the market.

Different product functions warrant different product safety and quality requirements adapted to their different intended uses. EU fertilising products should therefore be divided into different product function categories, which should each be subject to specific safety and quality requirements.

An EU fertilising product might have more than one of the functions described in the product function categories set out in this Regulation. Where only one of those functions is claimed, it should be sufficient for the EU fertilising product to comply with the requirements of the product function category describing that claimed function. By contrast, where more than one of those functions are claimed, the EU fertilising product should be regarded as a blend of two or more component EU fertilising products, and compliance should be required for each of the component EU fertilising products with respect to its function. A specific product function category should therefore cover such blends.

A manufacturer using one or more EU fertilising products that have already been subject to a conformity assessment, by that manufacturer or another manufacturer, might wish to rely on that conformity assessment. For the purpose of reducing the administrative burden to a minimum, the resulting EU fertilising product should also be regarded as a blend of two or more component EU fertilising products, and the additional conformity requirements for the blend should be limited to the aspects that are warranted by the blending.

Different component materials warrant different process requirements and control mechanisms adapted to their different potential hazardousness and variability. Component materials for EU fertilising products should therefore be divided into different categories, which should each be subject to specific process requirements and control mechanisms. It should be possible to make available on the market an EU fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.

Contaminants in EU fertilising products, such as cadmium, could pose a risk to human, animal or plant health, to safety or to the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in EU fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

Several Member States have in place national provisions limiting cadmium content in phosphate fertilisers on grounds relating to the protection of human health and of the environment. Should a Member State deem it necessary to maintain such national provisions after the adoption of harmonised limit values under this Regulation, and until those harmonised limit values are equal to or lower than the national limit values already in place, it should notify them to the Commission in accordance with Article 114(4) TFEU. Furthermore, in accordance with Article 114(5) TFEU, if a Member State deems it necessary to introduce new national provisions, such as provisions limiting cadmium content in phosphate fertilisers, based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of this Regulation, it should notify the Commission of the envisaged provisions as well as the grounds for introducing them. In either case, the Commission should verify in accordance with Article 114(6) TFEU whether or not the notified national provisions are a means of arbitrary discrimination, a disguised restriction on trade or an obstacle to the functioning of the internal market.

In view of the fact that certain Member States have been granted derogations from Article 5 of Regulation (EC) No 2003/2003 in accordance with TFEU relating to cadmium content in fertilisers on the grounds, inter alia, of the protection of human health and the environment in the context of particular soil and climactic conditions prevailing in those Member States, and since the factual circumstances that led to the granting of those derogations by the Commission remain valid, those Member States should be able to continue to apply their national limit values for cadmium content until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than those limit values are applicable at Union level.

In order to facilitate the compliance of phosphate fertilisers with the requirements of this Regulation and to boost innovation, sufficient incentives should be provided for the development of relevant technologies, particularly decadmiation technology, and for the management of cadmium-rich hazardous waste in the form of relevant financial resources such as those available under Horizon Europe, the Circular Economy Finance Support Platform or through the European Investment Bank. Those incentives should target cadmium removal solutions that will be economically viable on an industrial scale and allow appropriate treatment of the waste generated.

An EU fertilising product complying with the requirements of this Regulation should be allowed to move freely on the internal market. Where one or more of the component materials is a derived product within the meaning of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (6), but has reached a point in the manufacturing chain beyond which it no longer poses any significant risk to human, animal or plant health, to safety or to the environment (the ‘end point in the manufacturing chain’), to continue subjecting the product to the provisions of that Regulation would represent an unnecessary administrative burden. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.

For each component material category which includes derived products within the meaning of Regulation (EC) No 1069/2009, the end point in the manufacturing chain should be determined in accordance with the procedures laid down in that Regulation. Where such an end point is reached before the EU fertilising product is placed on the market but after the manufacturing process regulated under this Regulation has started, the process requirements of both Regulation (EC) No 1069/2009 and this Regulation should apply cumulatively to EU fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.

Derived products within the meaning of Regulation (EC) No 1069/2009 which are already placed on the market and used in the Union as organic fertilisers and soil improvers in accordance with that Regulation constitute promising raw materials for the production of innovative fertilising products in a circular economy. As soon as an end point in the manufacturing chain has been determined for the respective derived product, the EU fertilising products containing such derived products in accordance with this Regulation should be granted free movement on the internal market without being subject to the requirements of Regulation (EC) No 1069/2009. For this purpose, the Commission should, without undue delay, carry out a first assessment to check whether an end point in the manufacturing chain can be determined.

In the event of risks to public or animal health from fertilising products derived from animal by-products, recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council (7) should be possible, as is the case for other categories of products derived from animal by-products.

The making available on the market of an animal by-product or a derived product within the meaning of Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined, or for which the determined end point has not been reached at the time of making available on the market, is subject to the requirements of that Regulation. Therefore, it would be misleading to provide for the product’s CE marking under this Regulation. Any product containing or consisting of such an animal by-product or derived product should therefore be excluded from the scope of this Regulation. Untreated animal by-products should not be subject to this Regulation.

For certain recovered wastes, such as struvite, biochar and ash-based products, within the meaning of Directive 2008/98/EC of the European Parliament and of the Council (8), a market demand for their use as fertilising products has been identified. Furthermore, certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques, as well as for fertilising products resulting from the recovery operation, in order to ensure that the use of those fertilising products does not lead to overall adverse environmental or human health impacts. For EU fertilising products, those requirements should be laid down in this Regulation. Therefore, as of the moment of compliance with all the requirements of this Regulation, such products should cease to be regarded as waste within the meaning of Directive 2008/98/EC, and it should, therefore, be possible for fertilising products containing or consisting of such recovered waste materials to access the internal market. To ensure legal certainty, take advantage of technical developments, and further stimulate the incentive among producers to make more use of valuable waste streams, the scientific analyses and the setting of recovery requirements at Union level for such products should start immediately after the entry into force of this Regulation. Accordingly, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining, without unnecessary delay, larger or additional categories of component materials eligible for use in the production of EU fertilising products.

Certain by-products within the meaning of Directive 2008/98/EC are currently used by manufacturers as components of fertilising products or can be expected to be used in future emerging markets. For such components, specific requirements should be laid down in a separate component material category in Annex II to this Regulation.

Certain substances and mixtures, commonly referred to as inhibitors, improve the nutrient release pattern of a nutrient in a fertiliser by delaying or stopping the activity of specific groups of micro-organisms or enzymes. For inhibitors made available on the market with the intention of them being added to fertilising products, the manufacturer should be responsible for ensuring that those inhibitors fulfil certain efficacy criteria. Therefore, those inhibitors should be considered as EU fertilising products under this Regulation. Furthermore, EU fertilising products containing such inhibitors should be subject to certain efficacy, safety and environmental criteria. Such inhibitors should therefore also be regulated as component materials for EU fertilising products.

Certain substances, mixtures and micro-organisms, referred to as plant biostimulants, are not as such inputs of nutrients, but nevertheless stimulate plants’ natural nutrition processes. Where such products aim solely at improving the plants’ nutrient use efficiency, tolerance to abiotic stress, quality traits or increasing the availability of confined nutrients in the soil or rhizosphere, they are by nature more similar to fertilising products than to most categories of plant protection products. They act in addition to fertilisers, with the aim of optimising the efficiency of those fertilisers and reducing the nutrient application rates. Such products should therefore be eligible for CE marking under this Regulation and excluded from the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (9). Regulation (EC) No 1107/2009 should therefore be amended accordingly.

Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, are plant protection products falling within the scope of that Regulation. Those products should remain under the control developed for such products and provided for by that Regulation. Where such products also have the function of a fertilising product, it would be misleading to provide for their CE marking under this Regulation, since the making available on the market of a plant protection product is contingent on a product authorisation valid in the Member State concerned. Therefore, such products should be excluded from the scope of this Regulation.

This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of human, animal and plant health, of safety and of the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC (10), Council Directive 89/391/EEC (11), Council Directive 91/676/EEC (12), Directive 2000/60/EC of the European Parliament and of the Council (13), Directive 2001/18/EC of the European Parliament and of the Council (14), Regulation (EC) No 852/2004 of the European Parliament and of the Council (15), Regulation (EC) No 882/2004 of the European Parliament and of the Council (16), Regulation (EC) No 1907/2006 of the European Parliament and of the Council (17), Commission Regulation (EC) No 1881/2006 (18), Council Regulation (EC) No 834/2007 (19), Regulation (EC) No 1272/2008 of the European Parliament and of the Council (20), Regulation (EU) No 98/2013 of the European Parliament and of the Council (21), Regulation (EU) No 1143/2014 of the European Parliament and of the Council (22), Regulation (EU) 2016/2031 of the European Parliament and of the Council (23), Directive (EU) 2016/2284 of the European Parliament and of the Council (24) and Regulation (EU) 2017/625 of the European Parliament and of the Council (25).

In line with common practice, nitrogen, phosphorus and potassium should be referred to as ‘primary macronutrients’, and calcium, magnesium, sodium and sulphur should be referred to as ‘secondary macronutrients’. Also in line with common practice, fertilisers should be referred to as ‘straight’ when they contain either only one macronutrient – regardless whether it is primary or secondary – or only one primary macronutrient in combination with one or more secondary macronutrients. In line with the same practice, fertilisers should be referred to as ‘compound’ when they contain either more than one primary macronutrient – regardless whether they also contain one or more secondary macronutrients – or contain no primary macronutrient but more than one secondary macronutrient.

Where an EU fertilising product contains a substance or mixture within the meaning of Regulation (EC) No 1907/2006, the safety of its constituent substances for the intended use should be established through registration pursuant to that Regulation. The information requirements should ensure that the safety of the intended use of the EU fertilising product is demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops, notably Member States’ national fertiliser legislation and Regulation (EC) No 1107/2009. Therefore, where the actual quantities placed on the market are lower than 10 tonnes per company per year, the information requirements determined by Regulation (EC) No 1907/2006 for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for use in EU fertilising products. Those information requirements should apply to the actual substances contained in the EU fertilising product, as opposed to the precursors used for the manufacturing of those substances. The precursors themselves, such as sulphuric acid used as a precursor for the production of single superphosphate, should not be regulated as component materials for the purpose of this Regulation, since chemical safety will be better ensured by regulating as component materials the substances formed from the precursors and actually contained in the EU fertilising product. The obligation to comply with all the requirements of a component material category should therefore apply to those substances.

Where the actual quantities of substances in EU fertilising products regulated by this Regulation are higher than 100 tonnes, the additional information requirements laid down in Regulation (EC) No 1907/2006 should apply directly by virtue of that Regulation. The application of the other provisions of Regulation (EC) No 1907/2006 should also remain unaffected by this Regulation.

Economic operators should be responsible for the compliance of EU fertilising products with this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Regulation, and also to guarantee fair competition on the internal market. Whenever appropriate, manufacturers and importers should carry out sample testing of the EU fertilising products that they have made available on the market, in order to protect the health and safety of consumers and the environment.

It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment of EU fertilising products should therefore remain solely the obligation of the manufacturer.

It is necessary to ensure that EU fertilising products from third countries that enter the internal market comply with this Regulation, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those EU fertilising products. Provision should therefore be made for importers to make sure that EU fertilising products which they place on the market comply with the requirements of this Regulation and that they do not place on the market EU fertilising products which do not comply with such requirements or present a risk to human, animal or plant health, to safety or to the environment. Provision should also be made for such importers to make sure that conformity assessment procedures have been carried out and that marking of EU fertilising products and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

When placing an EU fertilising product on the market, importers should indicate on the packaging of the EU fertilising product their name, registered trade name or registered trade mark and the postal address at which they can be contacted, in order to enable market surveillance.

Since distributors make an EU fertilising product available on the market after it has been placed on the market by the manufacturer or the importer, they should act with due care to ensure that their handling of the EU fertilising product does not adversely affect the compliance of that EU fertilising product with this Regulation.

Economic operators who either place an EU fertilising product on the market under their own name or trade mark or modify an EU fertilising product in such a way that compliance with this Regulation may be affected should be considered to be manufacturers and should assume the obligations of manufacturers. In other cases, economic operators who only package or repackage EU fertilising products already placed on the market by other economic operators should be able to prove that compliance with the requirements of this Regulation has not been affected, by indicating their identity on the package and by keeping a copy of the original labelling information.

Since distributors and importers are close to the market place, they should be involved in market surveillance tasks carried out by competent national authorities, and should be required to participate actively and provide those authorities with all necessary information relating to the EU fertilising product.

Ensuring traceability of an EU fertilising product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators who made non-compliant EU fertilising products available on the market. When keeping the information required for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with an EU fertilising product or to whom they have supplied an EU fertilising product, since such updated information is normally not available to them.

In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for EU fertilising products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (26) or with common specifications adopted in accordance with this Regulation.

In order to enable economic operators to demonstrate and the competent authorities to verify that EU fertilising products made available on the market comply with the requirements of this Regulation, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least stringent to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. It should be possible for manufacturers to choose a more stringent conformity assessment procedure for the assessment of an EU fertilising product eligible for a less stringent procedure, since this might enable the manufacturers to streamline their administration without jeopardising the conformity of the EU fertilising product. Furthermore, it is necessary to adapt the modules established by Decision No 768/2008/EC in order to reflect specific aspects of fertilising products. In particular, it is necessary to reinforce the quality systems and the involvement of notified bodies for the conformity assessment of certain EU fertilising products derived from recovered waste.

In order to ensure that ammonium nitrate fertilisers of high nitrogen content do not endanger safety, and that such fertilisers are not used for purposes other than those for which they are intended, for example as explosives, such fertilisers should be subject to specific requirements relating to detonation resistance testing and to traceability.

To ensure effective access to information for market surveillance purposes, information regarding conformity with all Union acts applicable to EU fertilising products should be given in the form of a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity.

The CE marking, indicating the conformity of an EU fertilising product with this Regulation, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of the CE marking in the case of EU fertilising products should be laid down.

Certain conformity assessment procedures set out in this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

It is essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards it should be presumed to comply with the corresponding requirements set out in this Regulation.

In order to ensure a consistent level of quality in the performance of conformity assessment of EU fertilising products, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

Due to the variable nature of certain component materials of EU fertilising products, and the potentially irreversible nature of some of the damage to which soil and crop exposure to impurities could lead, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity of EU fertilising products, should be the only means of demonstrating the technical competence of conformity assessment bodies.

Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for EU fertilising products to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

It is necessary to provide for an efficient and transparent notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

Since the services offered by notified bodies in a Member State might relate to EU fertilising products made available on the market throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

In the interests of easing market access, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

In order to ensure legal certainty, it is necessary to clarify that rules on internal market surveillance and control of products entering the internal market provided for in Regulation (EC) No 765/2008 apply to EU fertilising products covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks.

EU fertilising products should be placed on the market only if they are sufficiently effective and do not present a risk to human, animal or plant health, to safety or to the environment when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.

Regulation (EC) No 2003/2003 provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against EC fertilisers considered to constitute a risk. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States.

The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to EU fertilising products presenting a risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such EU fertilising products.

The obligations of market surveillance authorities under this Regulation to require economic operators to take corrective actions should only apply to fertilising products bearing the CE marking when they are made available on the market. Those obligations should therefore be without prejudice to any possibility existing under national law to allow the economic operator to remove the CE marking and to legally place the product on the market as a product not falling within the scope of this Regulation.

In order to achieve the objectives of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adaptation to technical progress, in particular in the field of production of fertilising products derived from animal by-products and in the field of waste recovery, as well as in the agricultural sector and the agro-food industry.

Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, and fertilising product production from animal by-products, such as biochar. It should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at Union level. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining and introducing additional component materials eligible for use in the production of EU fertilising products and corresponding contaminant limit values in such products. That empowerment should only apply to the extent justified by technical progress established after the adoption of this Regulation, and not for the purpose of amending any elements of this Regulation in the absence of new evidence of such progress. In order to base the introduction of new contaminant limit values in EU fertilising products on full consideration of the direct and indirect impact on food and feed safety and on the environment, scientific opinions of the European Food Safety Authority, the European Chemicals Agency or the Commission’s Joint Research Centre, as relevant, should be taken into account prior to the adoption of new contaminant limit values. For derived products within the meaning of the Regulation (EC) No 1069/2009, component material categories should be expanded or added only to the extent that an end point in the manufacturing chain has been determined in accordance with the procedures laid down in that Regulation, since derived products for which no such end point has been determined are in any event excluded from the scope of this Regulation.

Since micro-organisms are not subject to registration under Regulation (EC) No 1907/2006 or any other horizontal Union legislation requiring manufacturers to demonstrate that the intended use is safe, they should be eligible as component materials for EU fertilising products only to the extent that they have been clearly identified and supported by data demonstrating that their use is safe, and indicated in an exhaustive list adopted on that basis. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adding new micro-organisms to that exhaustive list on the same basis.

An EU fertilising product can contain polymers other than nutrient polymers. However, this should be limited to cases where the purpose of the polymer is that of controlling the release of nutrients or increasing the water retention capacity or wettability of the EU fertilising product. It should be possible for innovative products containing such polymers to access the internal market. In order to minimise risks to human health, to safety or to the environment that may be posed by polymers other than nutrient polymers, the criteria for their biodegradability, so that they are capable of undergoing physical and biological decomposition, should be established. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining the criteria for the conversion of polymeric carbon into carbon dioxide and a related testing method. Polymers which do not comply with those criteria should be prohibited after a transitional period.

Furthermore, it should be possible to react immediately to new scientific evidence and to new risk assessments regarding human, animal or plant health, safety or the environment. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the requirements applicable to various categories of EU fertilising products.

When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (27). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers to adopt acts should be conferred on the Commission in order to determine whether measures taken by Member States in respect of non-compliant EU fertilising products are justified or not. Since those acts will relate to the question of whether national measures are justified, such acts should not be subject to control by the Member States.

In order to further ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (28).

The advisory procedure should be used for the adoption of implementing acts requiring the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.

The examination procedure should be used for the adoption of implementing acts laying down in common specifications uniform conditions for implementing the requirements of this Regulation and tests for verifying the conformity of EU fertilising products where harmonised standards have not been adopted, or do not satisfy the requirements of this Regulation, or where there are undue delays in the process of adopting or updating these standards; amending or repealing common specifications where non-compliance of EU fertilising products can be attributed to shortcomings in those common specifications; determining whether a national measure taken in respect of a compliant EU fertilising product that presents a risk to human, animal or plant health, to safety or to the environment is justified or not.

The Commission should adopt immediately applicable implementing acts determining whether a national measure taken in respect of a compliant EU fertilising product that presents a risk is justified or not where, in duly justified cases relating to the protection of human, animal or plant health, safety or the environment, imperative grounds of urgency so require.

Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

In view of the need to ensure a high level of environmental protection and the need to take into account new developments based on scientific facts, the Commission should submit to the European Parliament and to the Council a report which includes a review of the limit values for cadmium content.

It is necessary to provide for transitional arrangements that allow the making available on the market of EC fertilisers that have been placed on the market in accordance with Regulation (EC) No 2003/2003 before the date of application of this Regulation without those products having to comply with further product requirements. Distributors should therefore be able to supply EC fertilisers that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation.

It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application should therefore be deferred to a date where those preparations can reasonably be finalised.

Since the objective of this Regulation, namely to guarantee the functioning of the internal market while ensuring that EU fertilising products on the market fulfil the requirements providing for a high level of protection of human, animal, and plant health, of safety and of the environment, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

animal by-products or derived products which are subject to the requirements of Regulation (EC) No 1069/2009 when made available on the market;

plant protection products covered by the scope of Regulation (EC) No 1107/2009.

Directive 86/278/EEC;

Directive 89/391/EEC;

Directive 91/676/EEC;

Directive 2000/60/EC;

Directive 2001/18/EC;

Regulation (EC) No 852/2004;

Regulation (EC) No 882/2004;

Regulation (EC) No 1881/2006;

Regulation (EC) No 1907/2006;

Regulation (EC) No 834/2007;

Regulation (EC) No 1272/2008;

Regulation (EU) No 98/2013;

Regulation (EU) No 1143/2014;

Regulation (EU) 2016/2031;

Directive (EU) 2016/2284;

Regulation (EU) 2017/625.

‘fertilising product’ means a substance, mixture, micro- organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency;

‘EU fertilising product’ means a fertilising product which is CE marked when made available on the market;

‘substance’ means a substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

‘mixture’ means a mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;

‘micro-organism’ means a micro-organism as defined in point 15 of Article 3 of Regulation (EC) No 1107/2009;

‘liquid form’ means a suspension or a solution, where a suspension is a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and a solution is a liquid that is free of solid particles, or a gel and includes pastes;

‘solid form’ means form characterised by structural rigidity and resistance to changes of shape or volume and in which the atoms are tightly bound to each other, either in a regular geometric lattice (crystalline solids) or in an irregular manner (an amorphous solid);

‘% by mass’ means a percentage of the mass of the entire EU fertilising product in the form in which it is made available on the market;

‘making available on the market’ means any supply of an EU fertilising product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of an EU fertilising product on the Union market;

‘manufacturer’ means any natural or legal 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;

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;

‘importer’ means any natural or legal person established within the Union who places an EU fertilising product from a third country on the Union market;

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EU fertilising product available on the market;

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by an EU fertilising product, by its production process or by the methods for its sampling and analysis;

‘harmonised standard’ means harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012;

‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to an EU fertilising product have been fulfilled;

‘conformity assessment body’ means a body that performs conformity assessment activities including testing, certification and inspection;

‘recall’ means any measure aimed at achieving the return of an EU fertilising product that has already been made available to the end-user;

‘withdrawal’ means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market;

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

‘CE marking’ means a marking by which the manufacturer indicates that the EU fertilising product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

meet the requirements set out in Annex I for the relevant product function category;

meet the requirements set out in Annex II for the relevant component material category or categories; and

be labelled in accordance with the labelling requirements set out in Annex III.

keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 5 years after the EU fertilising product covered by those documents has been placed on the market;

further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EU fertilising product;

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by EU fertilising products covered by the authorised representative’s mandate.

ensure that the packaging bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’; and

keep a specimen of the original information referred to in Article 6(7) or Article 8(4) at the disposal of the market surveillance authorities for 5 years after having made the EU fertilising product available on the market.

any economic operator who has supplied them with an EU fertilising product;

any economic operator to whom they have supplied an EU fertilising product.

those requirements or tests are not covered by harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union;

the Commission observes undue delays in the adoption of requested harmonised standards; or

the Commission has decided in accordance with the procedure referred to in Article 11(5) of Regulation (EU) No 1025/2012 to maintain with restriction or to withdraw the references to the harmonised standards or parts thereof by which those requirements or tests are covered.

personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

appropriate knowledge and understanding of the requirements set out in Annexes I, II and III, of the applicable harmonised standards referred to in Article 13 and common specifications referred to in Article 14 and of the relevant provisions of Union harmonisation legislation and of national legislation;

the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

any circumstances, affecting the scope of or conditions for notification;

any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

failure of the EU fertilising product to meet the requirements set out in Annex I, II or III;

shortcomings in the harmonised standards referred to in Article 13;

shortcomings in the common specifications referred to in Article 14.

the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 18 of this Regulation;

the identification number of the notified body has been affixed in violation of Article 18 or has not been affixed, where required by Article 18;

the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

the technical documentation is either not available or not complete;

the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;

any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.

which have the potential to be the subject of significant trade on the internal market, and

for which there is scientific evidence that they:

name of the micro-organism;

taxonomic classification of the micro-organism: genus, species, strain and procurement method;

scientific literature reporting about safe production, conservation and use of the micro-organism;

taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority;

information on the production process, including, where relevant, processing methods such as spray drying, fluid-bed drying, static drying, centrifugation, deactivation by heat, filtration and grinding;

information on the identity and residue levels of residual intermediates, toxins or microbial metabolites in the component material; and

natural occurrence, survival and mobility in the environment.

the polymer is capable of undergoing physical and biological decomposition in natural soil conditions and aquatic environments across the Union, so that it ultimately decomposes only into carbon dioxide, biomass and water;

the polymer has at least 90 % of the organic carbon converted into carbon dioxide in a maximum period of 48 months after the end of the claimed functionality period of the EU fertilising product indicated on the label, and as compared to an appropriate standard in the biodegradation test; and

the use of polymers does not lead to accumulation of plastics in the environment.

in Article 5, paragraphs 2 and 3 are replaced by the following:

‘2.   For derived products referred to in Articles 32, 35 and 36 which no longer pose any significant risk to public or animal health, an end point in the manufacturing chain may be determined, beyond which they are no longer subject to the requirements of this Regulation.

Those derived products may subsequently be placed on the market without restrictions under this Regulation and shall no longer be subject to official controls in accordance with this Regulation.

The Commission is empowered to adopt delegated acts in accordance with Article 51a supplementing this Regulation by determining an end point in the manufacturing chain, beyond which derived products referred to in this paragraph are no longer subject to the requirements of this Regulation.

• 3. 

  In the event of risks to public or animal health, Articles 53 and 54 of Regulation (EC) No 178/2002 concerning emergency health measures shall apply mutatis mutandis to the derived products referred to in Articles 32, 33 and 36 of this Regulation.

• 4. 

  Within six months after 15 July 2019, the Commission shall initiate a first assessment of derived products referred to in Article 32 that are already widely used in the Union as organic fertilisers and soil improvers. This assessment shall cover at least the following products: meat meal, bone meal, meat-and-bone meal, hydrolysed proteins of Category 3 materials, processed manure, compost, biogas digestion residues, feather meal, glycerine and other products of Category 2 or 3 materials derived from the production of biodiesel and renewable fuels, as well as petfood, feed and dog chews that have been refused for commercial reasons or technical failures, and derived products from blood of animals, hides and skins, hoofs and horns, guano of bats and birds, wool and hair, feather and downs, and pig bristles. Where the assessment concludes that those derived products no longer pose any significant risk to public or animal health, the Commission shall determine an end point in the manufacturing chain pursuant to paragraph 2 of this Article without undue delay and in any case no later than six months after the assessment is finalised.’;

the following Article is inserted:

‘Article 51a

Exercise of the delegation

• 1. 

  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

• 2. 

  The power to adopt delegated acts referred to in Article 5(2) shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

• 3. 

  The delegation of power referred to in Article 5(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

• 4. 

  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (*1).

• 5. 

  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

• 6. 

  A delegated act adopted pursuant to Article 5(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

(*1)  OJ L 123, 12.5.2016, p. 1.’"

in Article 2(1), point (b) is replaced by the following:

in Article 3, the following point is added:

in Article 80, the following paragraph is added:

‘8.   To a product which was granted an authorisation under Article 32(1) based on an application submitted before 15 July 2019, and which after that date falls under the definition in point 34 of Article 3, this Regulation shall continue to apply for the duration provided in the authorisation.’

an assessment of the functioning of the internal market for fertilising products, including conformity assessment and market surveillance effectiveness and an analysis of the effects of optional harmonisation on production, market shares and trade flows of EU fertilising products and fertilising products placed on the market under national rules;

a review of the limit values for cadmium content in phosphate fertilisers, with a view to assessing the feasibility of reducing these limit values to a lower appropriate level on the basis of available technologies and scientific evidence on cadmium exposure and accumulation in the environment, taking into account environmental factors, in particular in the context of soil and climatic conditions, health factors, as well as socio-economic factors, including considerations of security of supply;

an assessment of the application of restrictions on levels of contaminants set out in Annex I and an assessment of any new relevant scientific information as regards the toxicity and carcinogenicity of contaminants that becomes available, including the risks from uranium contamination in fertilising products.

Articles 4(3), 14, 42, 43, 44, 45, 46 and 47 shall apply from 15 July 2019; and

Articles 20 to 36 shall apply from 16 April 2020.

I.

Solid organic fertiliser

II.

Liquid organic fertiliser

I.

Solid organo-mineral fertiliser

II.

Liquid organo-mineral fertiliser

I.

Inorganic macronutrient fertiliser

II.

Inorganic micronutrient fertiliser

A.

Organic soil improver

B.

Inorganic soil improver

A.

Nitrification inhibitor

B.

Denitrification inhibitor

C.

Urease inhibitor

A.

Microbial plant biostimulant

B.

Non-microbial plant biostimulant

1.

This Part sets out the requirements related to the PFCs to which EU fertilising products belong by virtue of their claimed function.

2.

The requirements laid down in this Annex for a given PFC apply to EU fertilising products in all subcategories of that PFC.

3.

The claim that an EU fertilising product complies with the function set out in this Annex for the relevant PFC shall be supported by the product’s mode of action, the relative content of its various components, or any other relevant parameter.

4.

Where compliance with a given requirement (such as absence of a given contaminant) follows certainly and uncontestably from the nature or manufacturing process of an EU fertilising product, that compliance can be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer.

5.

Where the EU fertilising product contains a substance for which maximum residue limit values for food and feed have been established in accordance with:

the use of the EU fertilising product as specified in the use instructions must not lead to the exceedance of those limit values in food or feed.

6.

Phosphonates shall not be intentionally added to any EU fertilising product. Unintentional presence of phosphonates shall not exceed 0,5 % by mass.

7.

The requirements in this Annex are expressed in oxidised form for certain nutrients. Where compliance is assessed based on the presence of the nutrient in question in its elemental form, the following conversion factors shall be used:

8.

The requirements in this Annex are expressed by reference to organic carbon (Corg). Where compliance is assessed based on organic matter the following conversion factor applies:

organic carbon (Corg) = organic matter × 0,56.

1.

An organic fertiliser shall contain:

of solely biological origin.

An organic fertiliser may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.

Contaminants in an organic fertiliser must not exceed the following limit values:

Biuret (C2H5N3O2) must not be present in an organic fertiliser.

3.

The copper (Cu) content in an organic fertiliser must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an organic fertiliser must not exceed 800 mg/kg dry matter.

4.

Pathogens in an organic fertiliser must not exceed the limits set out in the following table:

Where:

1.

A solid organic fertiliser shall be in solid form.

2.

A solid organic fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a solid organic fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

Where a solid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

The sum of those nutrient contents shall be at least 4 % by mass.

3.

Organic carbon (Corg) content in a solid organic fertiliser shall be at least 15 % by mass.

1.

A liquid organic fertiliser shall be in liquid form.

2.

A liquid organic fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a liquid organic fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

Where a liquid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

The sum of those nutrient contents shall be at least 3 % by mass.

3.

Organic carbon (Corg) content in a liquid organic fertiliser shall be at least 5 % by mass.

1.

An organo-mineral fertiliser shall be a co-formulation of:

An organo-mineral fertiliser may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.

Where one or more of the inorganic fertilisers in the co-formulation is a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), an organo-mineral fertiliser shall not contain 16 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

3.

Contaminants in an organo-mineral fertiliser must not exceed the following limit values:

4.

The copper (Cu) content in an organo-mineral fertiliser must not exceed 600 mg/kg dry matter, and the zinc (Zn) content in an organo-mineral fertiliser must not exceed 1 500 mg/kg dry matter. However, these limit values shall not apply where copper (Cu) or zinc (Zn) has been intentionally added to an organo-mineral fertiliser for the purpose of correcting a soil micronutrient deficiency and is declared in accordance with Annex III.

5.

Pathogens in an organo-mineral fertiliser must not exceed the limits set out in the following table:

Where:

1.

A solid organo-mineral fertiliser shall be in solid form.

2.

A solid organo-mineral fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a solid organo-mineral fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

Where a solid organo-mineral fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

The sum of those nutrient contents shall be at least 8 % by mass.

3.

Organic carbon (Corg) content in a solid organo-mineral fertiliser shall be at least 7,5 % by mass.

4.

In a solid organo-mineral fertiliser, each physical unit shall contain organic carbon (Corg) and all the nutrients in their declared content. A physical unit refers to one of the component pieces of a product, such as granules or pellets.

1.

A liquid organo-mineral fertiliser shall be in liquid form.

2.

A liquid organo-mineral fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a liquid organo-mineral fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

Where a liquid organo-mineral fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

The sum of those nutrient contents shall be at least 6 % by mass.

3.

Organic carbon (Corg) content in a liquid organo-mineral fertiliser shall be at least 3 % by mass.

1.

An inorganic fertiliser shall be a fertiliser containing or releasing nutrients in a mineral form, other than an organic or organo-mineral fertiliser.

2.

In addition to the requirements of either PFC 1(C)(I) or PFC 1(C)(II), an inorganic fertiliser which contains more than 1 % by mass of organic carbon (Corg), other than organic carbon (Corg) from:

shall meet the requirement that pathogens in an inorganic fertiliser must not exceed the limits set out in the following table:

Where:

1.

An inorganic macronutrient fertiliser shall be aimed at providing plants or mushrooms with one or more of the following macronutrients:

2.

Contaminants in an inorganic macronutrient fertiliser must not exceed the following limit values:

3.

The copper (Cu) content in an inorganic macronutrient fertiliser must not exceed 600 mg/kg dry matter, and the zinc (Zn) content in an inorganic macronutrient fertiliser must not exceed 1 500 mg/kg dry matter. However, these limit values shall not apply where copper (Cu) or zinc (Zn) has been intentionally added to an inorganic macronutrient fertiliser for the purpose of correcting a soil micronutrient deficiency and is declared in accordance with Annex III.

1.

A straight solid inorganic macronutrient fertiliser shall have a declared content of:

2.

Where a straight solid inorganic macronutrient fertiliser contains only one declared macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), that macronutrient content shall be at least the following:

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

Where a straight solid inorganic macronutrient fertiliser contains only one declared primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more declared secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)):

The sum of all declared primary and secondary macronutrient contents shall be at least 18 % by mass.

1.

A compound solid inorganic macronutrient fertiliser shall have a declared content of:

2.

A compound solid inorganic macronutrient fertiliser shall contain more than one of the following declared macronutrients in at least the following contents:

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

1.

A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be ammonium nitrate (NH4NO3)-based and contain 28 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

2.

Any matter other than ammonium nitrate (NH4NO3) shall be inert towards ammonium nitrate (NH4NO3).

3.

A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be made available to the end-user only in packaged form. The package shall be closed in such a way or by such a device that, when it is opened, the fastening, the fastening seal or the package itself is irreparably damaged. Valve sacks may be used.

4.

The oil retention of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, following two thermal cycles as described under point 4.1 in Module A1 in Part II of Annex IV, must not exceed 4 % by mass.

5.

The detonation resistance of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be such, that:

one or more of the supporting lead cylinders is crushed by less than 5 %.

6.

The % by mass of combustible material measured as carbon (C) must not exceed:

7.

A solution of 10 g of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content in 100 ml of water must have a pH of at least 4,5.

8.

Not more than 5 % by mass shall pass through a 1 mm mesh sieve, and not more than 3 % by mass shall pass through a 0,5 mm mesh sieve.

9.

The copper (Cu) content shall not be higher than 10 mg/kg, and the chlorine (Cl) content shall not be higher than 200 mg/kg.

1.

A straight liquid inorganic macronutrient fertiliser shall have a declared content of:

2.

Where a straight liquid inorganic macronutrient fertiliser contains only one declared macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), that macronutrient content shall be at least the following:

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

Where a straight liquid inorganic macronutrient fertiliser contains only one declared primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), and one or more declared secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)):

The sum of all declared primary and secondary macronutrient contents shall be at least 7 % by mass.

1.

A compound liquid inorganic macronutrient fertiliser shall have a declared content of:

2.

A compound liquid inorganic macronutrient fertiliser shall contain more than one of the following declared nutrients in at least the following contents:

However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.

1.

An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than an inorganic macronutrient fertiliser aimed at providing plants or mushrooms with one or more of the following micronutrients: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) or zinc (Zn).

2.

Inorganic micronutrient fertilisers shall be made available to the end-user only in packaged form.

3.

Contaminants in an inorganic micronutrient fertiliser must not exceed the following limit values:

1.

A straight inorganic micronutrient fertiliser shall have a declared content of not more than one micronutrient.

2.

A straight inorganic micronutrient fertiliser shall belong to one of the typologies, and shall comply with the corresponding description and minimum micronutrient content requirements in the following table:

1.

A compound inorganic micronutrient fertiliser shall have a declared content of more than one micronutrient.

2.

The sum of all declared micronutrient contents in a compound inorganic micronutrient fertiliser shall be at least:

1.

A liming material shall be an EU fertilising product the function of which is to correct soil acidity.

A liming material shall contain oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg).

2.

Contaminants in a liming material must not exceed the following limit values:

3.

The copper (Cu) content in a liming material must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in a liming material must not exceed 800 mg/kg dry matter.

4.

The following parameters determined on the basis of the mass of a liming material shall be met:

1.

An organic soil improver shall consist of material 95 % of which is of solely biological origin.

An organic soil improver may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.

Contaminants in an organic soil improver must not exceed the following limit values:

3.

The copper (Cu) content in an organic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an organic soil improver must not exceed 800 mg/kg dry matter.

4.

Pathogens in an organic soil improver must not exceed the limits set out in the following table:

Where:

5.

An organic soil improver shall contain 20 % or more dry matter.

6.

Organic carbon (Corg) content in an organic soil improver shall be at least 7,5 % by mass.

1.

An inorganic soil improver shall be a soil improver other than an organic soil improver.

2.

Contaminants in an inorganic soil improver must not exceed the following limit values:

3.

The copper (Cu) content in an inorganic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an inorganic soil improver must not exceed 800 mg/kg dry matter.

1.

A growing medium shall be an EU fertilising product other than soil in situ, the function of which is for plants or mushrooms to grow in.

For the purpose of this point, plants include algae.

2.

Contaminants in a growing medium must not exceed the following limit values:

3.

The copper (Cu) content in a growing medium must not exceed 200 mg/kg dry matter, and the zinc (Zn) content in a growing medium must not exceed 500 mg/kg dry matter.

4.

Pathogens in a growing medium must not exceed the limits set out in the following table:

Where:

1.

A nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-).

2.

The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by:

Compared to a control sample where the nitrification inhibitor has not been added, a soil sample containing the nitrification inhibitor shall show a 20 % reduction in ammoniacal nitrogen (NH3-N) oxidation rate based on an analysis carried out 14 days after application at the 95 % confidence level.

1.

A denitrification inhibitor shall inhibit the formation of nitrous oxide (N2O) by slowing down or blocking the conversion of nitrate (NO3-) to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A).

2.

Compared to a control sample where the denitrification inhibitor has not been added, an in vitro test containing the denitrification inhibitor shall show a 20 % reduction in rate of the release of nitrous oxide (N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

1.

A urease inhibitor shall inhibit hydrolytic action on urea (CH4N2O) by the urease enzyme, primarily targeted to reduce ammonia volatilisation.

2.

Compared to a control sample where the urease inhibitor has not been added, an in vitro test containing the urease inhibitor shall show a 20 % reduction in the rate of hydrolysis of urea (CH4N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

1.

A plant biostimulant shall be an EU fertilising product the function of which is to stimulate plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

2.

Contaminants in a plant biostimulant must not exceed the following limit values:

3.

The copper (Cu) content in a plant biostimulant must not exceed 600 mg/kg dry matter, and the zinc (Zn) content in a plant biostimulant must not exceed 1 500 mg/kg dry matter.

4.

The plant biostimulant shall have the effects that are claimed on the label for the plants specified thereon.

1.

A microbial plant biostimulant shall consist of a micro-organism or a consortium of micro-organisms referred to in CMC 7 in Part II of Annex II.

2.

Pathogens in a microbial plant biostimulant must not exceed the limits set out in the following table:

Where:

3.

When the microbial plant biostimulant is in liquid form, the plant biostimulant shall have a pH optimal for contained micro-organisms and for plants.

1.

A non-microbial plant biostimulant shall be a plant biostimulant other than a microbial plant biostimulant.

2.

Pathogens in a non-microbial plant biostimulant must not exceed the limits set out in the following table:

Where:

1.

A fertilising product blend shall be an EU fertilising product composed of two or more EU fertilising products of PFC 1 to PFC 6 for which the compliance with the requirements of this Regulation of each component EU fertilising product in the blend has been demonstrated in accordance with the conformity assessment procedure applicable to that component EU fertilising product.

2.

The blending shall not change the nature of each component EU fertilising product and shall not have an adverse effect on human, animal or plant health, on safety, or on the environment, under reasonably foreseeable conditions of storage or use of the fertilising product blend.

3.

The manufacturer of the blend shall assess the conformity of the blend with the requirements set out in points 1 and 2 of this PFC, ensure the blend’s compliance with the labelling requirements laid down in Annex III, and assume responsibility pursuant to Article 16(4) of this Regulation for the compliance of the blend with the requirements of this Regulation by:

4.

Economic operators making fertilising product blends available on the market shall respect the following provisions of this Regulation with regard to the EU declaration of conformity of each component EU fertilising product as well as of the blend:

1.

An EU fertilising product may contain substances and mixtures, except (1):

2.

All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006 (2), with a dossier containing:

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation.

3.

Where the substance or one of the substances in the mixture is intended to enhance the long term availability to plants of micronutrients in the EU fertilising product, that substance shall be either a chelating agent or a complexing agent, and the following rules shall apply:

4.

Where the substance or one of the substances in the mixture is intended to improve the EU fertilising product’s nutrient release patterns by delaying or stopping the activity of specific groups of micro-organisms or enzymes, that substance shall be an a nitrification inhibitor, a denitrification inhibitor or a urease inhibitor, and the following rules shall apply:

At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O).

1.

An EU fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials:

2.

The composting shall take place in a plant:

3.

The aerobic composting shall consist of controlled decomposition of biodegradable materials, which is predominantly aerobic and which allows the development of temperatures suitable for thermophilic bacteria as a result of biologically produced heat. All parts of each batch shall be either regularly and thoroughly moved and turned or subject to forced ventilation in order to ensure the correct sanitation and homogeneity of the material. During the composting process, all parts of each batch shall have one of the following temperature-time profiles:

4.

The compost shall contain:

From 16 July 2026, the presence of plastics above 2 mm within the maximum limit value referred to in point (b) shall be no more than 2,5 g/kg dry matter. By 16 July 2029 the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

5.

The compost shall meet at least one of the following stability criteria:

1.

An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

2.

The anaerobic digestion shall take place in a plant:

3.

The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles:

4.

Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

1.

An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

2.

The anaerobic digestion shall take place in a plant:

3.

The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles:

4.

Neither the solid nor the liquid part of the digestate shall contain more than 6 mg/kg dry matter of PAH16 (10).

5.

The digestate shall contain:

From 16 July 2026, the presence of plastics above 2 mm within the maximum limit value referred to in point (a) shall be no more than 2,5 g/kg dry matter. By 16 July 2029 the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

6.

Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

1.

An EU fertilising product may contain component material consisting of one of the following substances:

2.

All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006 (11), with a dossier containing:

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8, or 9 of Annex V to that Regulation.

have undergone no other processing than drying or freeze-drying; and

are listed in the following table:

1.

An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in points 1 and 2 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.

2.

At least 60 % of the polymers shall be soluble in a phosphate buffer solution with a pH of 7,5 at 100 °C.

3.

The final degradation products shall be only ammonia (NH3), water and carbon dioxide (CO2).

4.

The polymers shall not contain more than 600 ppm of free formaldehyde.

1.

An EU fertilising product may contain polymers other than nutrient polymers only in cases where the purpose of the polymer is:

2.

From 16 July 2026, the polymers referred to in point 1(a) and (b) shall comply with the biodegradability criteria established by delegated acts referred to in Article 42(6). In the absence of such criteria, an EU fertilising product placed on the market after that date shall not contain such polymers.

3.

For the polymers referred to in point 1(a) and (b), neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the EU fertilising product. The polymer shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:

1.

An EU fertilising product may contain by-products within the meaning of Directive 2008/98/EC, except (13):

2.

The by-products shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation.

3.

From 16 July 2022, the by-products shall comply with the criteria established by delegated act referred to in Article 42(7). An EU fertilising product placed on the market after that date shall not contain by-products referred to in point 1 which do not comply with such criteria.

1.

The following information shall be provided:

2.

Where the EU fertilising product has functions described in two or more of the PFCs laid down in Annex I, only those functions for which the EU fertilising product has been subject to a successful conformity assessment in accordance with this Regulation may be claimed by using the corresponding PFC designations as indicated in Part I of Annex I.

3.

Where the EU fertilising product contains a substance for which maximum residue limits for food and feed have been established in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, the instructions referred to in point 1(d) shall ensure that the intended use of the EU fertilising product does not lead to the exceedance of those limits in food or feed.

4.

Where the EU fertilising product contains derived products within the meaning of Regulation (EC) No 1069/2009 other than manure, the following instruction shall be provided on the label: ‘Farmed animals shall not be fed, either directly or by grazing, with herbage from land to which the product has been applied unless the cutting or grazing takes place after the expiry of a waiting period of at least 21 days.’.

5.

Where the EU fertilising product contains ricin, the following instruction shall be provided on the label: ‘Hazardous to animals in case of ingestion’.

6.

Where the EU fertilising product contains unprocessed or processed cocoa shells, the following instruction shall be provided on the label: ‘Toxic to dogs and cats’.

7.

Where the EU fertilising product contains a polymer with the purpose of binding material in the product, as referred to in point 1(c) of CMC 9 in Part II of Annex II, the user shall be instructed not to use the product in contact with soil, and in collaboration with the manufacturer, make sure of a sound disposal of the products after end of use.

8.

Information other than the information required under points 1 to 6:

9.

The phrase ‘poor in chloride’ or similar may only be used if the chloride (Cl-) content is below 30 g/kg of dry matter.

10.

Where the nutrient content information requirements in this Annex are expressed in oxidised form, the nutrient content may be expressed in elemental form instead or in addition to the oxidised form in accordance with the following conversion factors:

phosphorus (P)= phosphorus pentoxide (P2O5) × 0,436;

potassium (K)= potassium oxide (K2O) × 0,830;

calcium (Ca)= calcium oxide (CaO) × 0,715;

magnesium (Mg)= magnesium oxide (MgO) × 0,603;

sodium (Na)= sodium oxide (Na2O) × 0,742;

sulphur (S)= sulphur trioxide (SO3) × 0,400.

11.

Where the information requirements in this Annex refer to organic carbon (Corg), the information may refer to organic matter instead of or in addition to organic carbon (Corg), in accordance with the following conversion factor:

1.

The content of nutrients may be declared only where they are present in the EU fertilising product in the minimum quantity specified in Annex I for the relevant PFC.

2.

If nitrogen (N) or phosphorus (P) are not declared nutrients, the content of nitrogen (N) or phosphorus pentoxide (P2O5) shall nevertheless be indicated if above 0,5 % by mass. That indication shall be separate from the nutrient declaration.

3.

The following rules apply to fertilisers containing inhibitors, as specified in CMC 1 in Part II of Annex II:

4.

The term ‘mineral fertiliser’ may be used only if the fertiliser belongs to PFC 1(C) and fulfils the following additional conditions: