PURPOSE: to ensure the proper functioning of the internal market while ensuring that EU fertilisers on the market comply with the requirements ensuring a high level of protection of animal and plant health, safety and the environment.

LEGISLATIVE ACT: 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 and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003.

CONTENT: The Regulation harmonises standards for fertilisers from organic or secondary raw materials, opening up new opportunities for large-scale production. In addition, it sets harmonised limits for a series of contaminants in inorganic fertilisers.

The new Regulation, which replaces the previous 2003 fertiliser regulation, includes all types of fertilisers.

Free movement

Member States shall not impede, for reasons relating to composition, labelling or other aspects covered by this Regulation, the making available on the market of EU fertilising products which comply with this Regulation.

A Member State which, on 14 July 2019 benefits from a derogation in relation to cadmium content in fertilisers granted may continue to apply the national limit values for cadmium content in fertilisers which are applicable in that Member State on 14 July 2019 to EU fertilising products until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than the limit values applicable in the Member State concerned on 14 July 2019 are applicable at Union level.

This Regulation shall not prevent Member States from maintaining or adopting provisions for the purpose of protecting human health and the environment which are in compliance with the Treaties, concerning the use of EU fertilising products, provided that those provisions do not require modification of EU fertilising products which are in compliance with this Regulation and do not influence the conditions for making them available on the market.

Requirements

According to the Regulation, CE-marked EU fertilizers shall meet certain requirements in order to move freely within the EU internal market. These requirements include maximum levels of contaminants, the use of defined classes of constituent substances, and labelling.

Tests for verifying the conformity of EU fertilising products with the requirements set out in Annexes I, II and III shall be performed in a reliable and reproducible manner.

Labelling

EU fertilisers shall be labelled in accordance with the labelling requirements set out in Annex III of the Regulation. By 16 July 2020 at the latest, the Commission shall publish a guidance document for manufacturers and market surveillance authorities containing clear information and examples on the visual appearance of the label.

Packaging and reconditioning

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.

Foster innovation

In order to facilitate the compliance of phosphate fertilisers with the requirements of the Regulation and to stimulate innovation, the text stresses the importance of providing sufficient incentives for the development of relevant technologies, in particular decadmiation technologies, and for the management of cadmium-rich hazardous waste in the form of adequate financial resources, such as those available under the Horizon Europe programme.

Report

By 16 July 2026 at the latest, the Commission shall submit a report assessing the implementation of the Regulation and its overall impact, including its effects on SMEs. This report shall include:

- 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;

- 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.

The report shall take due account of technological progress and innovation as well as standardisation processes affecting production and use of fertilising products. It shall be accompanied, if appropriate, by a legislative proposal.

The Commission may adopt delegated acts with regard to the amendment of the requirements applicable to the various categories of EU fertilisers.

ENTRY INTO FORCE: 15.7.2019.

APPLICATION: from 16.7.2022.

The European Parliament adopted by 582 votes to 38 with 7 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009.

Parliament’s position adopted in first reading following the ordinary legislative procedure amended the Commission’s proposal as follows:

The Regulation harmonises standards for fertilizers from organic or secondary raw materials, opening up new opportunities for large-scale production. In addition, it sets harmonised limits for a series of contaminants in inorganic fertilizers.

Free movement

Member States shall not impede, for reasons relating to composition, labelling or other aspects covered by this Regulation, the making available on the market of EU fertilising products which comply with the Regulation.

A Member State which benefits from a derogation in relation to cadmium content in fertilisers may continue to apply the national limit values for cadmium content in fertilisers which are applicable in that Member State to EU fertilising products until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than the limit values applicable in the Member State concerned are applicable at Union level.

The Regulation shall not prevent Member States from maintaining or adopting provisions for the purpose of protecting human health and the environment which are in compliance with the Treaties, concerning the use of EU fertilising products, provided that those provisions do not require modification of EU fertilising products which are in compliance with this Regulation.

Requirements

According to the draft regulation, CE-marked EU fertilizers should meet certain requirements in order to move freely within the EU internal market. These requirements include maximum levels of contaminants, the use of defined classes of constituent substances, and labelling.

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. Tests for verifying the conformity of EU fertilising products with the requirements set out in Annexes I, II and III shall be performed in a reliable and reproducible manner.

Labelling

Manufacturers shall ensure that EU fertilising products are accompanied by the information required under Annex III. Where an EU fertilising product is supplied in a package, the information shall appear on a label that is affixed to that package. Where the package is too small to contain all the information, the information that cannot be provided on the label shall be provided in a separate leaflet accompanying that package.

No later than one year after the date of entry into force of the Regulation, the Commission should publish a guidance document for manufacturers and market surveillance authorities, which contains clear information and examples regarding the visual appearance of the label.

Packaging or repackaging

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.

Delegated acts

The Commission may adopt delegated acts to supplement the Regulation as regards:

- defining, without unnecessary delay, larger or additional categories of component materials eligible for use in the production of EU fertilising products;

- defining and introducing additional component materials eligible for use in the production of EU fertilising products and corresponding contaminant limit values in such products;

- defining the criteria for the conversion of polymeric carbon into carbon dioxide and a related testing method. Polymers that do not comply with those criteria should be prohibited after a transitional period.

Report

Seven years after the date of entry into force of the Regulation, the Commission shall submit a report assessing the application of the Regulation and its overall impact as to the attainment of its objectives, including the impact on small and medium-sized enterprises. That report shall include:

- 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;

- 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.

The report shall take due account of technological progress and innovation as well as standardisation processes affecting production and use of fertilising products. It shall be accompanied, if appropriate, by a legislative proposal.

The European Parliament adopted by 298 votes to 234, with 135 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009.

The matter has been referred back to the committee responsible for interinstitutional negotiations.

As a reminder, the proposal for a Regulation on fertilisers in the context of the circular economy package aims to harmonise European rules for organic waste products and by-products. It modernises conformity assessment and market surveillance in accordance with the ‘new legislative framework’ for product legislation.

The main amendments adopted in plenary are as follows:

Definitions : it is proposed to replace the term ‘fertilising product’ with ‘ plant nutrition product ’, while clarifying this definition, as well as the definition of ‘substance’.

Recycled or organic materials : Members seek to promote increased use of recycled nutrients in order to further contribute to the development of the circular economy while reducing the Union’s dependence on nutrients imported from third countries.

In this context, farmers should use those products which follow the spirit of "responsible agriculture", favouring local distribution channels. The preferential use of fertilisers produced on-site and in neighbouring agricultural undertakings should be encouraged.

Facilitating market access for innovative organic fertilisers : Members suggest facilitating compliance of phosphate fertilising products with the requirements of this Regulation and boosting innovation by providing incentives for the development of relevant technologies, in particular decadmiation and the management of cadmium-rich hazardous wastes through the financial resources available under the Horizon 2020 programme, the LIFE programmes and the Circular Economy Platform through the European Investment Bank (EIB) or other financial instruments. The Commission shall report annually to the European Parliament and the Council on the incentives and the Union funding provided for decadmiation.

To take advantage of technical developments and unlock the potential to make more use of nutrients from animal by-products such as animal manure, the setting of processing methods and recovery rules for animal by-products for which an end-point in the manufacturing chain has been determined (the point beyond which they no longer represent a risk to public and animal health) should start immediately after the entry into force of the Regulation.

Provide limits for contaminants : the traceability of products which are sensitive to organic pollution from certain potentially problematic sources (or perceived as such) should be ensured back to the source of the organic material. This is necessary in order to secure consumer confidence and to limit damage if local contamination occurs.

Cadmium limits : contaminants in CE marked fertilising products, if the latter are not used correctly, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. According to the amended text, the cadmium limits would be reduced from 60 mg/kg to 40 mg/kg after six years (instead of the three years proposed by the European Commission), and to 20 mg/kg after sixteen years , to allow producers to adapt to these requirements.

Obligations of economic operators : in order to protect the health and safety of consumers and the environment , manufacturers shall carry out sample testing of fertilising products made available on the market and inform distributors and market surveillance authorities of any such monitoring. Manufacturers shall keep the technical documentation and the EU declaration of conformity for five years after the CE marked fertilising product covered by those documents has been placed on the market.

Only compliant CE marked fertiliser can be imported into the Union and placed on the Union market.

Importers shall indicate the third country manufacturers on the packaging of the CE marked fertilising product. Distributors shall verify that the required information is provided in a document accompanying the fertiliser.

Members considered it important that the labelling is clear and comprehensive and that it includes all the information on the available nutrients and their solubility. The Commission shall publish a guidance document giving details and examples to manufacturers and market surveillance authorities about the appearance of the label.

The CE marking should be affixed in a visible, legible and indelible manner on the package

Parliament stated that the Regulation does not prevent Member States from maintaining or adopting provisions which are in compliance with the Treaties, concerning the use of CE marked fertilising products for the purpose of protecting human health and the environment, provided that those provisions do not require modification of CE marked fertilising products which are in compliance with this Regulation and do not influence the conditions for making them available on the market.

Assessment and report : Members introduced a review clause requiring the European Commission to assess (42 months after the date of application of the Regulation):

the functioning of the internal market for fertilisers, including the conformity assessment and market surveillance effectiveness; the application of restrictions of contaminant levels as set out in Annex I to this Regulation and any new relevant scientific information on the toxicity and carcinogenicity of contaminants; developments in decadmiation technologies ; trade impacts on the sourcing of raw materials, including the availability of phosphate rock classified by the Commission as a critical raw material;

One year after the date of entry into force of the Regulation, the Commission shall present an evaluation of the scientific data used to establish the agronomic and environmental criteria to define end-of-livestock manure criteria in order qualify the performance of products containing or consisting of processed livestock manure.

Lastly, five years after the date of entry into force of the Regulation at the latest, the Commission shall review the conformity assessment procedure of micro-organisms .

The Committee on the Internal Market and Consumer Protection adopted the report by Ildikó Gáll-Pelcz (EPP, HU) on the proposal for a regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009.

The Committee on the Environment, Public Health and Food Safety as well as the Committee on Agriculture and Rural Development, exercising their prerogatives as associated committees in accordance with Article 54 of the Rules of Procedure, also gave their opinions on the report.

As a reminder, the proposal for a Regulation on fertilisers in the context of the circular economy package aims to harmonise European rules for organic waste products and by-products. It modernises conformity assessment and market surveillance in accordance with the ‘new legislative framework’ for product legislation.

The committee recommended that the European Parliament's position adopted at first reading in accordance with the ordinary legislative procedure should amend the Commission proposal as follows.

Definitions : it is proposed to replace the term ‘fertilising product’ with ‘ plant nutrition product ’, while clarifying this definition, as well as the definition of ‘substance’.

Recycled or organic materials : Members seek to promote increased use of recycled nutrients in order to further contribute to the development of the circular economy while reducing the Union’s dependence on nutrients imported from third countries.

Facilitating market access for innovative organic fertilisers : Members suggest facilitating compliance of phosphate fertilising products with the requirements of this Regulation and boosting innovation by providing incentives for the development of relevant technologies, in particular decadmiation and the management of cadmium-rich hazardous wastes through the financial resources available under the Horizon 2020 program, the LIFE programs and the Circular Economy Platform through the European Investment Bank ( EIB) or other financial instruments. The Commission should report annually to the European Parliament and the Council on the incentives and the Union funding provided for decadmiation.

Provide limits for contaminants : the traceability of products which are sensitive to organic pollution from certain potentially problematic sources (or perceived as such) should be ensured back to the source of the organic material. This is necessary in order to secure consumer confidence and to limit damage if local contamination occurs.

Obligations of economic operators : in order to protect the health and safety of consumers and the environment, manufacturers shall carry out sample testing of fertilising products made available on the market and inform distributors and market surveillance authorities of any such monitoring.

Only compliant CE marked fertiliser can be imported into the Union and placed on the Union market.

Importers shall indicate the third country manufacturers on the packaging of the CE marked fertilising product. Distributors shall verify that the required information is provided in a document accompanying the fertiliser.

Members considered it important that the labelling is clear and comprehensive and that it includes all the information on the available nutrients and their solubility. The Commission shall publish a guidance document giving details and examples to manufacturers and market surveillance authorities about the appearance of the label.

The CE marking should be affixed in a visible, legible and indelible manner on the package

The report stated that the Regulation does not prevent Member States from maintaining or adopting provisions which are in compliance with the Treaties, concerning the use of CE marked fertilising products for the purpose of protecting human health and the environment, provided that those provisions do not require modification of CE marked fertilising products which are in compliance with this Regulation and do not influence the conditions for making them available on the market.

Assessment and report : Members introduced a review clause requiring the European Commission to assess (42 months after the date of application of the Regulation):

the functioning of the internal market for fertilisers, including the conformity assessment and market surveillance effectiveness; the application of restrictions of contaminant levels as set out in Annex I to this Regulation and any new relevant scientific information on the toxicity and carcinogenicity of contaminants; developments in decadmiation technologies ; trade impacts on the sourcing of raw materials, including the availability of phosphate rock .

One year after the date of entry into force of the Regulation, the Commission shall present an evaluation of the scientific data used to establish the agronomic and environmental criteria to define end-of-livestock manure criteria in order qualify the performance of products containing or consisting of processed livestock manure.

Lastly, five years after the date of entry into force of the Regulation at the latest, the Commission shall review the conformity assessment procedure of micro-organisms.

PURPOSE: to guarantee the functioning of the internal market in fertilizing products while ensuring that CE marked fertilising products on the market fulfil the requirements providing for a high level of protection of human, animal, and plant health, safety and the environment.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLEOF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: 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.

Virtually all product-types currently included in the existing Fertilisers Regulation are conventional, inorganic fertilisers, typically extracted from mines or chemically produced in line with a linear economy model. These processes are both energy consuming and CO2-intensive.

Around 50 % of the fertilisers currently on the market are left out of the scope of the Regulation . This is true for a few inorganic fertilisers and for virtually all fertilisers produced from organic materials, such as animal or other agricultural by products, or recycled bio-waste from the food chain.

As a result, fertilisers sourced in line with the circular economy remain non-harmonised . Their access to the single market is therefore dependent on mutual recognition between Member States, which is often difficult due to diverging national rules.

Furthermore, the existing Fertilisers Regulation fails to address environmental concerns arising from contamination by EC-fertilisers of soil, inland waters, seawaters, and ultimately food.

The ex-post evaluation of the existing Fertilisers Regulation conducted in 2010 concluded that the Regulation could be more effective in promoting innovative fertilisers , and that adjustments would also be needed to better protect the environment . The Commission proposes to establish harmonised conditions for making fertilisers made from recycled or organic materials available on the entire internal market in order to provide an important incentive for their further use.

IMPACT ASSESSMENT: the impact assessment compared status quo (referred to as option 1) with four other policy options. Under the four options, the scope of harmonisation would be extended to fertilisers from organic raw materials and to other fertiliser-related products, and limit values would be introduced for contaminants.

The final proposal corresponds with the option that would build on the 'New Legislative Framework' ('NLF'), with one conformity assessment procedure varying between material categories. This was considered to be the best policy choice because it would lead to administrative simplification, in particular for fertilising products from well identified, primary raw materials, and ensure flexibility, while at the same time ensuring that the use of harmonised fertilising products does not pose unacceptable risks to health or the environment.

CONTENT: the proposal seeks to repeal the existing Fertilisers Regulation and to address the problems identified in the evaluation conducted in 2010. It has also been identified as one of the key legislative proposals under the circular economy action plan.

The main policy objective of the initiative is to incentivise large-scale fertiliser production in the EU from domestic organic or secondary raw materials in line with the circular economy model , by transforming waste into nutrients for crops.

The draft regulation provides a regulatory framework radically easing access to the internal market for such fertilisers, thereby levelling their playing field with that of mined or chemical fertilisers produced in line with a linear economy model. This would contribute to the following circular economy objectives by:

allowing valorisation of secondary raw materials, hence enabling improved use of raw materials and turning eutrophication and waste management problems into economic opportunities for public and private operators; increasing resource efficiency and decrease import dependency for raw materials essential to European agriculture, in particular phosphorus; boosting investment and innovation in the circular economy, hence creating jobs in the EU; contributing to relieving the fertilisers industry from its current pressure to reduce CO2-emissions under ETS, by allowing it to produce fertilisers from less carbon-intensive feedstock.

A second policy objective is to address the issue of soil and food contamination and introduce harmonised cadmium limits for phosphate fertilisers . The Regulation introduces strict limits for cadmium in phosphate fertilisers. The limits will be tightened from 60 mg/kg to 40 mg/kg after three years and to 20 mg/kg after 12 years, reducing health and environmental risks.

To achieve these objectives , the proposal:

sets out the subject matter, scope and definitions, as well as the fundamental principles of free movement and marketability of CE marked fertilising products . The provision on product requirements are contained in the Annexes, which include the substantive requirements for the categories of end products in accordance with their intended function (Annex I), as well as for the categories of component materials that can be contained in CE marked fertilising products (Annex II). Annex III specifies the labelling requirements; lays down the obligations of economic operators involved in making CE marked fertilising products available on the market; sets out the general principle for conformity of CE marked fertilising products. It refers to Annex IV, which describes in detail the conformity assessment procedures applicable to CE marked fertilising products, depending on their component material categories and their product function categories. It also refers to Annex V, which sets out the model structure for the EU declaration of conformity. sets out the provisions on notified bodies , and on market surveillance .

DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.