Commission Delegated Regulation (EU) 2021/1768 of 23 June 2021 amending, for the purpose of its adaptation to technical progress, Annexes I, II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (1), and in particular Article 42(1) thereof,

Whereas:

(1) A fertilising product, which meets the requirements laid down in Annexes I and II to Regulation (EU) 2019/1009 for the relevant product function category (‘PFC’) and component material category (‘CMC’) respectively, is labelled in accordance with Annex III to that Regulation and has successfully passed the conformity assessment procedure laid down in Annex IV to Regulation (EU) 2019/1009, can then be CE marked and can move freely in the internal market as an EU fertilising product.

(2) Regulation (EU) 2019/1009 empowers the Commission to amend Annexes I (partly), II, III and IV thereto.

(3) While preparing for the transition to new harmonisation rules, both Member States and interested stakeholders informed the Commission about the need to adapt some of the technical provisions in the annexes to Regulation (EU) 2019/1009. Some of those amendments are necessary in order to improve consistency with other pieces of Union legislation, which would facilitate internal market access and the free movement of safe and agronomically efficient fertilising products. Some amendments are necessary to secure the high level of protection that Regulation (EU) 2019/1009 aims to achieve, thereby ensuring that EU fertilising products having access to the internal market by virtue of that Regulation do not present a risk to health, safety or the environment. Other amendments are necessary in order to avoid situations in which significant categories of fertilising products would inadvertently be excluded from the harmonisation rules. Those amendments will secure internal market access for fertilising products that are agronomically efficient, safe, and already widely traded on the market.

(4) Regulation (EU) 2019/1009 lays down rules for EU fertilising products containing a substance with maximum residue limit values for food and feed laid down in accordance with Council Regulation (EEC) No 315/93 (2), in Regulation (EC) No 396/2005 of the European Parliament and of the Council (3), in Regulation (EC) No 470/2009 of the European Parliament and of the Council (4), or in Directive 2002/32/EC of the European Parliament and of the Council (5). The manufacturer is obliged to provide use instructions to ensure that the intended use of the EU fertilising product does not lead to the exceedance of the maximum limit values for food and feed. In addition, the manufacturer is to include in the technical documentation the results of calculations that prove compliance with this requirement. In the discussions on how to implement this obligation, it has become clear that it is impossible for manufacturers to comply therewith, thus preventing agronomically efficient, safe, and already widely traded fertilising products from passing the conformity assessment and accessing the internal market under Regulation (EU) 2019/1009. Those obligations should therefore be replaced by obligations that are more proportionate and implementable in two aspects.

(5) Firstly, the exceedance of those maximum limits or levels in crops can be prevented by providing correct information to the end-user on the label. Consequently, Regulation (EU) 2019/1009 should be amended so as to impose an obligation upon the manufacturer to inform the end-user whenever the EU fertilising product contains a component material which, if placed on the market as food or feed, exceeds the maximum limits or levels set in Regulations (EC) No 470/2009 or (EC) No 396/2005, in accordance with Regulation (EEC) No 315/93, or in Directive 2002/32/EC. Furthermore, in order to ensure a high level of protection of human health, animal health and the environment in relation to feed additives, Regulation (EC) No 1831/2003 of the European Parliament and of the Council (6) should be added. In this way, the end-user will be in a position to take all necessary measures to ensure that the crop is compliant with the food and feed rules.

(6) Secondly, additional measures are needed regarding some pharmacologically active substances already covered by Regulation (EC) No 470/2009. The approach should be different depending on whether it is an allowed substance listed in Table 1 in the Annex to Commission Regulation (EU) No 37/2010 (7), and for which a maximum residue limit may have been set, or it is a non-allowed substance with a reference point for action laid down in Commission Regulation (EU) 2019/1871 (8). Residues of an allowed substance may be present in an EU fertilising product only if the said substance is listed in Table 1 in the Annex to Regulation (EU) No 37/2010. However, a non-allowed pharmacologically active substance, which is more hazardous to the health of the consumer when present in foodstuff, should not be present above its reference point of action in an EU fertilising product either.

(7) An EU fertilising product may also contain active substances within the meaning of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (9). As Regulation (EU) 2019/1009 does not cover plant protection products, it should be made clear in the text of that regulation that an EU fertilising product containing an active substance must not have a plant protection function within the meaning of Regulation (EC) No 1107/2009. This clarification is needed to ensure consistency with Regulation (EC) No 1107/2009, which will facilitate the implementation of the harmonisation rules both by economic operators and by national authorities, thereby facilitating access to the internal market based on Regulation (EU) 2019/1009.

(8) Regulation (EU) 2019/1009 contains an exhaustive list of typologies for a straight inorganic micronutrient fertiliser, as well as their corresponding descriptions and minimum micronutrient content. For micronutrient salt fertiliser, 10 % by mass of the fertiliser consists of a water-soluble micronutrient. However, there are fertilisers based on carbonate or phosphate salts that have micronutrients that are not water-soluble. This does not affect their performance as fertilisers or the uptake of nutrients in the crop. Such micronutrient salt fertilisers should therefore be allowed access to the internal market by removing the water-soluble condition. For UVCB (10) chelates, only iron chelates are listed. However, other micronutrients may also be UVCB chelates and may be slowly released to plants. Slow release fertilisers are useful in preventing nutrient pollution in soils, by slowly releasing the micronutrients and thus increasing the chances of their absorption by the plants. It is, therefore, appropriate to include such niche products within the scope of the harmonisation rules and promote their free movement on the internal market.

(9) Regulation (EU) 2019/1009 lays down limit values for contaminants, including nickel, in a growing medium, which is an EU fertilising product other than soil in situ, the function of which is for plants or mushrooms to grow in. Regulation (EU) 2019/1009 sets harmonisation rules for this type of fertilising product. There are already numerous kinds of growing media on the market, based on national rules and with very diverse characteristics, which could be candidates for becoming EU fertilising products. However, the limit value for nickel set out in Regulation (EU) 2019/1009 for all types of growing media creates difficulties for some growing media containing solely constituents of mineral origin. Such products are niche products that comply with the principles of the circular economy and already satisfy the EU Ecolabel criteria established for growing media by Commission Decision (EU) 2015/2099 (11). In this Decision, a distinction is made between mineral growing media and other categories of growing media as regards the methods of determining the content of contaminants, including nickel. Thus, for all growing media except mineral growing media, the total content of the contaminant is to be determined, while for mineral growing media only the bioavailable content is to be determined. This distinction is justified by the fact that mineral growing media are usually manufactured at high temperatures, producing a strong chemical bond of contaminants with the structure of the mineral constituents, limiting the extent to which such contaminants are biologically available. However, such a distinction is not made in Regulation (EU) 2019/1009. Based on the information available, while mineral growing media available on the market would comply with the limit value set for nickel in Regulation (EU) 2019/1009 if only the bioavailable content of the contaminant is to be determined, they cannot comply with the same limit if the total content is to be determined, as is currently required. It is therefore important to ensure consistency between the requirements for the CE marking of those products based on Regulation (EU) 2019/1009 and applying the Ecolabel, in order to avoid the unintended situation in which products safe for the environment and therefore having an Ecolabel would be outside the scope of the harmonisation rules. Thus, the limit value for nickel laid down in Annex I to Regulation (EU) 2019/1009 should apply only to the bioavailable content for mineral growing media.

(10) As a safeguard measure, that rule should apply only where the use of those products is limited to professional use in horticultural applications, green roofs or green walls. This would ensure a better handling and a higher recovery rate of the used growing media, with real possibilities of recycling the materials after use. In addition, the manufacturer should also collaborate with the user to ensure the safe disposal of the products once they are no longer in use. Furthermore, the product should not enter into direct contact with the soil, so as not to contribute to the accumulation of contaminants therein.

(11) EU fertilising products may contain only component materials compliant with the requirements laid down for one of the component material categories in Annex II to Regulation (EU) 2019/1009. Fertilising products, in particular fertilisers, often contain polymer-based technical additives, which are important to ensure their efficiency and safe use. Those additives are not covered by any of the existing component material categories. However, fertilisers containing them are covered by the harmonisation rules in Regulation (EC) No 2003/2003 of the European Parliament and of the Council (12). Such technical additives are, for instance, anti-caking agents preventing the formation of lumps, and anti-dusting agents preventing dust emissions from the fertilising product during its application. Anti-caking agents are essential for the nutrient use efficiency as without such agents, the fertiliser would not spread evenly and therefore the end-user would apply more fertiliser to make sure that it reaches all plants. Anti-dusting agents are also very important for protecting users’ health. Polymers that do not cause any environmental concern should therefore be included among the component materials allowed in fertilising products under Regulation (EU) 2019/1009. This would ensure that significant categories of products with an improved agronomic efficiency and safety continue to have access to the internal market.

(12) In order to identify which polymers do not cause any environmental concern, it is appropriate to refer to the scientific opinions issued by the Risk Assessment Committee (13) and the Committee for Socioeconomic Analysis of the European Chemical Agency in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (14), on intentionally added microplastic particles to consumer or professional use products of any kind.

(13) By including these categories of polymers in CMC 1 (Virgin material substances and mixtures) and CMC 11 (By-products within the meaning of Directive 2008/98/EC of the European Parliament and of the Council (15)), it is also ensured that those polymers will be registered under Regulation (EC) No 1907/2006 with a dossier including a safety report for their use as a fertilising product. This would ensure that a detailed assessment of any risks from the use of these additives in fertilising products would be carried out, and that the fertilising products granted internal market access under this amendment are thus safe for human health and the environment.

(14) Fertilisers with micronutrients may contain chelating or complexing agents, which are substances intended to enhance the long-term availability of micronutrients to plants.

(15) Regulation (EU) 2019/1009 requires fertilising products containing chelating agents to remain stable in standard Hoagland solution at pH 7 and 8 for at least three days, to ensure that the micronutrients are slowly released to plants. The composition of agricultural soils and variations in pH can disturb the stability of these products. New technical progress allows to assess potential interferences and to establish a pH range where products are stable for agricultural purposes. Based on the above, a product may be stable at a pH range other than pH 7 and 8, and still fulfil its purpose of ensuring long-term availability of micronutrients. Therefore, Regulation (EU) 2019/1009 should be amended to allow such products to be stable within a different pH range. In this way, the harmonisation rules would apply to more products, which slowly release micronutrients to plants and thus reduce the leaching of nutrients in soils. As an additional measure, the pH range in which the EU fertilising products are stable should be indicated on the label to ensure that correct information is provided to the end-user.

(16) Regulation (EU) 2019/1009 requires the declaration of the percentage of each micronutrient chelated by each chelating agent and of each micronutrient complexed by each complexing agent, as applicable. Products with micronutrients may contain a mixture of chelating agents, or complexing agents, or both. In such cases, the analytical methods available cannot support the determination of the exact percentage of each micronutrient chelated or complexed by each individual agent. Thus, Regulation (EU) 2019/1009 should be amended in order to allow the manufacturer to comply with these labelling requirements, thereby facilitating their access to the internal market.

(17) Some fertilising products, such as growing media, use peat as a main component. Encouraging the use of alternatives to peat is important in the fight against climate change, especially for the prevention of carbon loss and greenhouse gas emissions, as well as the conservation of fragile ecosystems. Plant fibres could be used to replace partially peat in growing media. However, to upgrade the potential of untreated plant fibres, these have to be transformed into fibres of finer particles as this improves their degree of biodegradability, their interaction with nutrients and water retention. Conditioning of the raw plant fibres using different physical pre-treatments for the purpose of fiberisation should be included in the exhaustive list of treatments in CMC 2 (Plants, plant parts and plant extracts). As a safeguard measure, certain restrictions should be added to the processing methods, such as maximum temperature and the prohibition of additives except water.

(18) CMC 3 (Compost) and CMC 5 (Digestate other than fresh crop digestate) lay down an exhaustive list of input materials that can be used. That list includes derived products referred to in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (16) and animal by-products that can be considered dead organisms, in cases where an end point in the manufacturing chain has been determined in accordance with Article 5(2), the third subparagraph of that Regulation.

(19) Regulation (EU) 2019/1009 lays down for the first time harmonisation rules for compost and digestate as component materials in EU fertilising products. These materials are nevertheless present on the market, based on national rules. Currently, animal by-products that cannot be considered dead organisms (especially unprocessed manure) are frequently used as input materials for compost and digestate. In this way, such materials are transformed into fertilising products with a net economic and environmental added value. The use of composted animal excrement, including poultry manure and composted farmyard manure, as well as digestate containing animal by-products co-digested with material of plant or animal origin is included in the exhaustive list of fertilisers, soil conditioners and nutrients allowed in organic farming in Annex I to Commission Regulation (EC) No 889/2008 (17). It is therefore appropriate to grant access to the internal market to fertilising products containing compost or digestate with such animal by-products as input materials. This would also ensure consistency with the input materials allowed in the recently introduced CMC 12 (Precipitated phosphate salts and derivates), CMC 13 (Thermal oxidation materials and derivates), as well as CMC 14 (Pyrolysis and gasification materials).

(20) CMCs 3 and 5 also exclude from their input materials living or dead organisms from the organic fraction of mixed municipal household waste. On the contrary, CMCs 12, 13 and 14 exclude from their input materials living or dead organisms out of the materials from mixed municipal waste, and not only household waste. The objective of those provisions is to encourage the separate collection of waste in municipalities, by not providing opportunities for the use of mixed waste. The reasoning is the same both if the waste is generated by households or by restaurants or other operators in municipalities. There is no reason to prohibit the use of only household mixed waste as input material in compost and digestate. Therefore, to ensure a coherent and stringent approach towards the recovery of mixed municipal waste and thus to reinforce the protection of the environment, it is necessary to align the provisions in CMCs 3 and 5 with those in the recently introduced CMCs 12, 13 and 14.