LegalizeRegulation (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 (Text with EEA relevance)
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 (Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
This Regulation does not apply to:
(a) animal by-products or derived products which are subject to the requirements of Regulation (EC) No 1069/2009 when made available on the market;
(b) plant protection products covered by the scope of Regulation (EC) No 1107/2009.
This Regulation does not affect the application of the following legal acts:
(a) Directive 86/278/EEC;
(b) Directive 89/391/EEC;
(c) Directive 91/676/EEC;
(d) Directive 2000/60/EC;
(e) Directive 2001/18/EC;
(f) Regulation (EC) No 852/2004;
(g) Regulation (EC) No 882/2004;
(h) Regulation (EC) No 1881/2006;
(i) Regulation (EC) No 1907/2006;
(j) Regulation (EC) No 834/2007;
(k) Regulation (EC) No 1272/2008;
(l) Regulation (EU) No 98/2013;
(m) Regulation (EU) No 1143/2014;
(n) Regulation (EU) 2016/2031;
(o) Directive (EU) 2016/2284;
(p) Regulation (EU) 2017/625.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘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;
(2) ‘EU fertilising product’ means a fertilising product which is CE marked when made available on the market;
(3) ‘substance’ means a substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;
(4) ‘mixture’ means a mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;
(5) ‘micro-organism’ means a micro-organism as defined in point 15 of Article 3 of Regulation (EC) No 1107/2009;
(6) ‘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;
(7) ‘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);
(8) ‘% 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;
(9) ‘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;
(10) ‘placing on the market’ means the first making available of an EU fertilising product on the Union market;
(11) ‘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;
(12) ‘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;
(13) ‘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;
(14) ‘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;
(15) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
(16) ‘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;
(17) ‘harmonised standard’ means harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012;
(18) ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
(19) ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
(20) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to an EU fertilising product have been fulfilled;
(21) ‘conformity assessment body’ means a body that performs conformity assessment activities including testing, certification and inspection;
(22) ‘recall’ means any measure aimed at achieving the return of an EU fertilising product that has already been made available to the end-user;
(23) ‘withdrawal’ means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market;
(24) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
(25) ‘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.
Article 3
Free movement
Article 4
Product requirements
An EU fertilising product shall:
(a) meet the requirements set out in Annex I for the relevant product function category;
(b) meet the requirements set out in Annex II for the relevant component material category or categories; and
(c) be labelled in accordance with the labelling requirements set out in Annex III.
Article 5
Making available on the market
EU fertilising products shall only be made available on the market if they comply with this Regulation.
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 6
Obligations of manufacturers
Where compliance of an EU fertilising product with the applicable requirements laid down in this Regulation has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
On request, manufacturers shall make a copy of the EU declaration of conformity available to other economic operators.
When deemed appropriate with regard to the performance of, or the risks presented by, an EU fertilising product, manufacturers shall carry out sample testing of such EU fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming EU fertilising products and recalls of such EU fertilising products, and shall keep distributors informed of any such monitoring.
Article 7
Authorised representative
The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) 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;
(b) 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;
(c) 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.
Article 8
Obligations of importers
Where an importer considers or has reason to believe that an EU fertilising product is not in conformity with this Regulation, the importer shall not place the EU fertilising product on the market until it has been brought into conformity. Furthermore, where the EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
On request, importers shall make a copy of the EU declaration of conformity available to other economic operators.
Article 9
Obligations of distributors
Where a distributor considers or has reason to believe that an EU fertilising product is not in conformity with this Regulation, the distributor shall not make the EU fertilising product available on the market until it has been brought into conformity. Furthermore, where the EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Article 10
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 6, where that importer or distributor places an EU fertilising product on the market under his or her name or trademark or modifies an EU fertilising product already placed on the market in such a way that compliance with this Regulation may be affected.
Article 11
Packaging and repackaging by importers and distributors
Where an importer or distributor packages or repackages an EU fertilising product and is not considered a manufacturer pursuant to Article 10, that importer or distributor shall:
(a) 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
(b) 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.
Article 12
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities:
(a) any economic operator who has supplied them with an EU fertilising product;
(b) any economic operator to whom they have supplied an EU fertilising product.
CHAPTER III
CONFORMITY OF EU FERTILISING PRODUCTS
Article 13
Presumption of conformity
Article 14
Common specifications
The Commission may adopt implementing acts laying down common specifications for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) where:
(a) 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;
(b) the Commission observes undue delays in the adoption of requested harmonised standards; or
(c) 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.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).
Article 15
Conformity assessment procedures
Article 16
EU declaration of conformity
Article 17
General principles of CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 18
Rules and conditions for affixing the CE marking
The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his or her authorised representative.
Article 19
End-of-waste status
This Regulation lays down criteria in accordance with which material that constitutes waste, as defined in Directive 2008/98/EC, can cease to be waste, if it is contained in a compliant EU fertilising product. In such cases, the recovery operation under this Regulation shall be performed before the material ceases to be waste, and the material shall be considered to comply with the conditions laid down in Article 6 of that Directive and therefore to have ceased to be waste from the moment that the EU declaration of conformity was drawn up.
CHAPTER IV
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 20
Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.
Article 21
Notifying authorities
Article 22
Requirements relating to notifying authorities
Article 23
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
Article 24
Requirements relating to notified bodies
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing or use of fertilising products or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times and for each conformity assessment procedure and each kind or category of EU fertilising products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b) 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;
(c) 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.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
The personnel responsible for carrying out the conformity assessment tasks shall have the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
(c) 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;
(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 25
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 24 in so far as the applicable harmonised standards cover those requirements.
Article 26
Subsidiaries of and subcontracting by notified bodies
Article 27
Application for notification
Article 28
Notification procedure
Only such a body shall be considered a notified body for the purposes of this Regulation.
Article 29
Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 30
Changes to notifications
Article 31
Challenge of the competence of notified bodies
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 45(2).
Article 32
Operational obligations of notified bodies
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the EU fertilising product with this Regulation.
Article 33
Appeal against decisions of notified bodies
Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.
Article 34
Information obligation on notified bodies
Notified bodies shall inform the notifying authority of the following:
(a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision;
(b) any circumstances, affecting the scope of or conditions for notification;
(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Article 35
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.
Article 36
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
Notified bodies shall participate in the work of that group, directly or by means of designated representatives.
CHAPTER V
UNION MARKET SURVEILLANCE, CONTROL OF EU FERTILISING PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 37
Union market surveillance and control of EU fertilising products entering the Union market
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to EU fertilising products.
Article 38
Procedure at national level for dealing with EU fertilising products presenting a risk
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the EU fertilising product does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature of the risk, to bring the EU fertilising product into compliance with those requirements, to withdraw the EU fertilising product from the market or to recall it.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant EU fertilising product, the origin of that EU fertilising product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
(a) failure of the EU fertilising product to meet the requirements set out in Annex I, II or III;
(b) shortcomings in the harmonised standards referred to in Article 13;
(c) shortcomings in the common specifications referred to in Article 14.
Article 39
Union safeguard procedure
If the national measure is considered justified, the decision shall order all Member States to take the necessary measures to ensure that the non-compliant EU fertilising product is withdrawn from their market, and to inform the Commission accordingly.
If the national measure is considered unjustified, the decision shall order the Member State concerned to withdraw that measure.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).
Article 40
Compliant EU fertilising products which present a risk
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).
On duly justified imperative grounds of urgency relating to the protection of human, animal or plant health, safety or the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).
Article 41
Formal non-compliance
Without prejudice to Article 38, where a Member State makes one of the following findings with regard to an EU fertilising product, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 18 of this Regulation;
(b) 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;
(c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;
(d) the technical documentation is either not available or not complete;
(e) the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;
(f) any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.
Obligations of Member States in this respect shall be without prejudice to the possibility for them to regulate fertilising products which are not EU fertilising products.
CHAPTER VI
DELEGATED POWERS AND COMMITTEE PROCEDURE
Article 42
Amendments of Annexes
The Commission is empowered to adopt delegated acts in accordance with Article 44 amending Annex I, with the exception of cadmium limit values and the definitions, or other elements relating to the scope, of product function categories, and amending Annexes II, III and IV, for the purposes of adapting those Annexes to technical progress and of facilitating internal market access and free movement for EU fertilising products:
(a) which have the potential to be the subject of significant trade on the internal market, and
(b) for which there is scientific evidence that they: (i) do not present a risk to human, animal or plant health, to safety or to the environment, and (ii) ensure agronomic efficiency.
When adopting delegated acts which introduce new contaminant limit values in Annex I, the Commission shall take into account scientific opinions of the European Food Safety Authority, the European Chemicals Agency or the Commission’s Joint Research Centre, as relevant.
Where the Commission adopts delegated acts in order to add or review component material categories so as to include materials that can be considered to be recovered waste or by-products within the meaning of Directive 2008/98/EC, those delegated acts shall explicitly exclude such materials from component material categories 1 and 11 of Annex II to this Regulation.
When adopting delegated acts under this paragraph, the Commission shall prioritise in particular animal by-products, by-products within the meaning of Directive 2008/98/EC, and recovered waste, in particular from the agricultural sector and the agro-food industry, as well as materials and products already lawfully placed on the market in one or more Member States.
The Commission may only adopt delegated acts pursuant to paragraph 1 amending Annex II to add new micro-organisms or strains of micro-organisms, or additional processing methods to the component material category for such organisms after having verified which strains of the additional micro-organism fulfil the criteria in point (b) of paragraph 1, on the basis of the following data:
(a) name of the micro-organism;
(b) taxonomic classification of the micro-organism: genus, species, strain and procurement method;
(c) scientific literature reporting about safe production, conservation and use of the micro-organism;
(d) taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority;
(e) 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;
(f) information on the identity and residue levels of residual intermediates, toxins or microbial metabolites in the component material; and
(g) natural occurrence, survival and mobility in the environment.
The Commission shall assess such derived products with respect to relevant aspects not taken into account for the purpose of determining an end point in the manufacturing chain in accordance with Regulation (EC) No 1069/2009. If that assessment concludes that the criteria in point (b) of paragraph 1 of this Article are fulfilled, the Commission shall adopt delegated acts pursuant to paragraph 1 of this Article to include those materials in the table in component material category 10 in Part II of Annex II to this Regulation without undue delay whenever such an end point is determined.
Such criteria shall ensure that:
(a) 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;
(b) 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
(c) the use of polymers does not lead to accumulation of plastics in the environment.
Article 43
Separate delegated acts for separate component material categories
When exercising its power to adopt delegated acts pursuant to Article 42, the Commission shall adopt a separate delegated act in respect of each component material category in Annex II. Those delegated acts shall include any amendments to Annexes I, III and IV which are necessary as a consequence of amendments to Annex II.
Article 44
Exercise of the delegation
Article 45
Committee procedure
CHAPTER VII
AMENDMENTS
Article 46
Amendments to Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009 is amended as follows:
(1) 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.
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.
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.’;
(2) the following Article is inserted: ‘Article 51a Exercise of the delegation
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
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.
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.
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).
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
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.
Article 47
Amendments to Regulation (EC) No 1107/2009
Regulation (EC) No 1107/2009 is amended as follows:
(1) in Article 2(1), point (b) is replaced by the following: ‘(b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant;’;
(2) in Article 3, the following point is added: ‘34. “plant biostimulant” means a product stimulating 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: (a) nutrient use efficiency; (b) tolerance to abiotic stress; (c) quality traits; (d) availability of confined nutrients in soil or rhizosphere.’;
(3) 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.’
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 48
Penalties
Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Article 49
Report
By 16 July 2026, the Commission shall submit to the European Parliament and to the Council a report assessing the application of this 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:
(a) 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;
(b) 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;
(c) 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.
Article 50
Biodegradability review
By 16 July 2024, the Commission shall carry out a review in order to assess the possibility of determining biodegradability criteria of mulch films, and the possibility of incorporating them into component material category 9 in Part II of Annex II.
Article 51
Repeal of Regulation (EC) No 2003/2003
Regulation (EC) No 2003/2003 is repealed with effect from 16 July 2022.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 52
Transitional provisions
Member States shall not impede the making available on the market of products which were placed on the market as fertilisers designated ‘EC fertiliser’ in conformity with Regulation (EC) No 2003/2003 before 16 July 2022. However, Chapter V of this Regulation shall apply mutatis mutandis to such products.
Article 53
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 16 July 2022.
However:
(a) Articles 4(3), 14, 42, 43, 44, 45, 46 and 47 shall apply from 15 July 2019; and
(b) Articles 20 to 36 shall apply from 16 April 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Product Function Categories (PFCs) of EU fertilising products
PART I
DESIGNATION OF PFCS
I.Solid organic fertiliser
II.Liquid organic fertiliser
I.Solid organo-mineral fertiliser
II.Liquid organo-mineral fertiliser
I.Inorganic macronutrient fertiliser
(a) Solid inorganic macronutrient fertiliser (i) Straight solid inorganic macronutrient fertiliser (A) Straight solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content (ii) Compound solid inorganic macronutrient fertiliser (A) Compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content
(b) Liquid inorganic macronutrient fertiliser (i) Straight liquid inorganic macronutrient fertiliser (ii) Compound liquid inorganic macronutrient fertiliser
II.Inorganic micronutrient fertiliser
(a) Straight inorganic micronutrient fertiliser
(b) Compound 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
PART II
REQUIREMENTS RELATED TO PFCS
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.Residues of a pharmacologically active substance within the meaning of Regulation (EC) No 470/2009 of the European Parliament and of the Council (1) may be present in an EU fertilising product only if that substance is either:
— included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2), or
— has had a reference point for action established in accordance with Commission Regulation (EU) 2019/1871 (3), and the substance or its residues are present in the EU fertilising product at a level below that reference point.
5a.An EU fertilising product may contain an active substance within the meaning of Article 2(2) of Regulation (EC) No 1107/2009 only if that EU fertilising product does not have a plant protection function within the meaning of Article 2(1) of that Regulation.
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.
A fertiliser shall be an EU fertilising product the function of which is to provide nutrients to plants or mushrooms.
1.An organic fertiliser shall contain:
— organic carbon (Corg) and
— nutrients
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:
(a) cadmium (Cd): 1,5 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 50 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter, and
(f) inorganic arsenic (As): 40 mg/kg dry matter.
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:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
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:
(a) 2,5 % by mass of total nitrogen (N),
(b) 2 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
Where a solid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:
(a) 1 % by mass of total nitrogen (N),
(b) 1 % by mass of total phosphorus pentoxide (P2O5), or
(c) 1 % by mass of total potassium oxide (K2O).
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:
(a) 2 % by mass of total nitrogen (N),
(b) 1 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
Where a liquid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:
(a) 1 % by mass of total nitrogen (N),
(b) 1 % by mass of total phosphorus pentoxide (P2O5), or
(c) 1 % by mass of total potassium oxide (K2O).
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:
(a) one or more inorganic fertilisers, as specified in PFC 1(C), and
(b) one or more materials containing: — organic carbon (Corg); and — nutrients of solely biological origin.
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:
(a) cadmium (Cd):
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter;
(c) mercury (Hg): 1 mg/kg dry matter;
(d) nickel (Ni): 50 mg/kg dry matter;
(e) lead (Pb): 120 mg/kg dry matter;
(f) inorganic arsenic (As): 40 mg/kg dry matter; and
(g) biuret (C2H5N3O2): 12 g/kg dry matter.
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:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
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:
(a) 2,5 % by mass of total nitrogen (N), out of which 1 % by mass shall be organic nitrogen (Norg),
(b) 2 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
Where a solid organo-mineral fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:
(a) 2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),
(b) 2 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
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:
(a) 2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),
(b) 2 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
Where a liquid organo-mineral fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:
(a) 2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),
(b) 2 % by mass of total phosphorus pentoxide (P2O5), or
(c) 2 % by mass of total potassium oxide (K2O).
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:
— chelating or complexing agents referred to in point 3 of component material category (CMC) 1 in Part II of Annex II,
— nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II,
— coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II,
— urea (CH4N2O), or
— calcium cyanamide (CaCN2)
shall meet the requirement that pathogens in an inorganic fertiliser must not exceed the limits set out in the following table:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
Where:
1.An inorganic macronutrient fertiliser shall be aimed at providing plants or mushrooms with one or more of the following macronutrients:
(a) primary macronutrients: nitrogen (N), phosphorus (P) or potassium (K),
(b) secondary macronutrients: calcium (Ca), magnesium (Mg), sodium (Na) or sulphur (S).
2.Contaminants in an inorganic macronutrient fertiliser must not exceed the following limit values:
(a) cadmium (Cd):
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 100 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter,
(f) arsenic (As): 40 mg/kg dry matter,
(g) biuret (C2H5N3O2): 12 g/kg dry matter,
(h) perchlorate (ClO4-): 50 mg/kg dry matter.
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.
A solid inorganic macronutrient fertiliser shall be in solid form.
1.A straight solid inorganic macronutrient fertiliser shall have a declared content of:
(a) only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or
(b) only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).
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:
(a) 10 % by mass of total nitrogen (N),
(b) 12 % by mass of total phosphorus pentoxide (P2O5),
(c) 6 % by mass of total potassium oxide (K2O),
(d) 5 % by mass of total magnesium oxide (MgO),
(e) 9 % by mass of total calcium oxide (CaO),
(f) 10 % by mass of total sulphur trioxide (SO3), or
(g) 1 % by mass of total sodium oxide (Na2O).
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)):
(a) that primary macronutrient content shall be at least the following: (i) 3 % by mass of total nitrogen (N), (ii) 3 % by mass of total phosphorus pentoxide (P2O5), or (iii) 3 % by mass of total potassium oxide (K2O);
(b) that or those secondary macronutrient contents shall be at least the following: (i) 1,5 % by mass of total magnesium oxide (MgO), (ii) 1,5 % by mass of total calcium oxide (CaO), (iii) 1,5 % by mass of total sulphur trioxide (SO3), or (iv) 1 % by mass of total sodium oxide (Na2O). However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.
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:
(a) more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or
(b) more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)) and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).
2.A compound solid inorganic macronutrient fertiliser shall contain more than one of the following declared macronutrients in at least the following contents:
(a) 3 % by mass of total nitrogen (N),
(b) 3 % by mass of total phosphorus pentoxide (P2O5),
(c) 3 % by mass of total potassium oxide (K2O),
(d) 1,5 % by mass of total magnesium oxide (MgO),
(e) 1,5 % by mass of total calcium oxide (CaO),
(f) 1,5 % by mass of total sulphur trioxide (SO3), or
(g) 1 % by mass of total sodium oxide (Na2O).
However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.
The sum of all declared macronutrient contents shall be at least 18 % 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:
— following five thermal cycles as described under point 4.3 in Module A1 in Part II of Annex IV,
— in two detonation resistance tests as described under point 4.4 in Module A1 in Part II of Annex IV,
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:
— 0,2 % for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content having a nitrogen (N) content of at least 31,5 % by mass, and
— 0,4 % for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content having a nitrogen (N) content of at least 28 % but less than 31,5 % by mass.
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.
A liquid inorganic macronutrient fertiliser shall be in liquid form.
1.A straight liquid inorganic macronutrient fertiliser shall have a declared content of:
(a) only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or
(b) only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).
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:
(a) 5 % by mass of total nitrogen (N),
(b) 5 % by mass of total phosphorus pentoxide (P2O5),
(c) 3 % by mass of total potassium oxide (K2O),
(d) 2 % by mass of total magnesium oxide (MgO),
(e) 6 % by mass of total calcium oxide (CaO),
(f) 5 % by mass of total sulphur trioxide (SO3), or
(g) 1 % by mass of total sodium oxide (Na2O).
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)):
(a) that primary macronutrient content shall be at least the following: (i) 1,5 % by mass of total nitrogen (N), (ii) 1,5 % by mass of total phosphorus pentoxide (P2O5), or (iii) 1,5 % by mass of total potassium oxide (K2O); and
(b) that or those secondary macronutrient contents shall be at least the following: (i) 0,75 % by mass of total magnesium oxide (MgO), (ii) 0,75 % by mass of total calcium oxide (CaO), (iii) 0,75 % by mass of total sulphur trioxide (SO3), or (iv) 0,5 % by mass of total sodium oxide (Na2O). However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.
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:
(a) more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or
(b) more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).
2.A compound liquid inorganic macronutrient fertiliser shall contain more than one of the following declared nutrients in at least the following contents:
(a) 1,5 % by mass of total nitrogen (N),
(b) 1,5 % by mass of total phosphorus pentoxide (P2O5),
(c) 1,5 % by mass of total potassium oxide (K2O),
(d) 0,75 % by mass of total magnesium oxide (MgO),
(e) 0,75 % by mass of total calcium oxide (CaO),
(f) 0,75 % by mass of total sulphur trioxide (SO3), or
(g) 0,5 % by mass of total sodium oxide (Na2O).
However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.
The sum of all declared nutrient contents shall be at least 7 % 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:
| Contaminant | Limit values of contaminants expressed in mg, in relation to the total micronutrient content expressed in kg ( mg/kg of total micronutrient content, which means boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn)) |
|---|---|
| Arsenic (As) | 1 000 |
| Cadmium (Cd) | 200 |
| Lead (Pb) | 600 |
| Mercury (Hg) | 100 |
| Nickel (Ni) | 2 000 |
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:
| Typology | Description | Minimum micronutrient content |
|---|---|---|
| Micronutrient salt fertiliser | A chemically obtained straight solid inorganic micronutrient fertiliser containing a mineral ion salt as its essential ingredient | 10 % by mass of micronutrient salt fertiliser shall consist of a micronutrient |
| Micronutrient oxide or hydroxide fertiliser | A chemically obtained straight solid inorganic micronutrient fertiliser containing oxide or hydroxide as its essential ingredient | 10 % by mass of a micronutrient oxide or hydroxide fertiliser shall consist of a micronutrient |
| Micronutrient-based fertiliser | A straight inorganic micronutrient fertiliser combining a micronutrient salt fertiliser with one or more other micronutrient salt fertilisers and/or with a single micronutrient chelate | 5 % by mass of a micronutrient-based fertiliser shall consist of a micronutrient |
| Micronutrient solution fertiliser | An aqueous solution of different forms of a straight inorganic micronutrient fertiliser | 2 % by mass of a micronutrient solution fertiliser shall consist of a water-soluble micronutrient |
| Micronutrient suspension fertiliser | A suspension of different forms of a straight inorganic micronutrient fertiliser | 2 % by mass of a micronutrient suspension fertiliser shall consist of a micronutrient |
| Micronutrient chelated fertiliser | A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II | — 5 % by mass of a micronutrient chelated fertiliser shall consist of a water-soluble micronutrient, and — at least 80 % of the water-soluble micronutrient shall be chelated by a chelating agent fulfilling the requirements of CMC 1 in Part II of Annex II |
| UVCB (1) micronutrient chelates | A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II | — 5 % by mass of UVCB micronutrient chelates shall consist of water-soluble micronutrient, and at least 80 % of the water-soluble micronutrient shall be chelated (chelated fraction) and at least 50 % of the water soluble micronutrient shall be chelated by specific chelating agents fulfilling the requirements of CMC 1 in Part II of Annex II |
| Micronutrient complexed fertiliser | A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with complexing agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II | — 5 % by mass of a micronutrient complexed fertiliser shall consist of a water-soluble micronutrient, and — at least 80 % of the water-soluble micronutrient shall be complexed by a complexing agent fulfilling the requirements of CMC 1 in Part II of Annex II |
| (1) UVCB: Substance of unknown or variable composition, complex reaction products or biological materials. |
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:
(a) 2 % by mass for fertilisers in liquid form;
(b) 5 % by mass for fertilisers in solid form.
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:
(a) cadmium (Cd): 2 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 90 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter,
(f) arsenic (As): 40 mg/kg dry matter.
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:
(a) minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-),
(b) minimum reactivity: 10 % (hydrochloric acid test) or 50 % after 6 months (incubation test), and
(c) minimum grain size: at least 70 % < 1 mm, except for burnt limes, granulated liming material and chalk (at least 70 % of the liming material shall pass through a 1 mm sieve).
A soil improver shall be an EU fertilising product the function of which is to maintain, improve or protect the physical or chemical properties, the structure or the biological activity of the soil to which it is added.
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:
(a) cadmium (Cd): 2 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 50 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter, and
(f) inorganic arsenic (As): 40 mg/kg dry matter.
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:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
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:
(a) cadmium (Cd): 1,5 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 100 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter,
(f) inorganic arsenic (As): 40 mg/kg dry matter.
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.
4.Pathogens in an inorganic soil improver that contains more than 1 % by mass of organic carbon (Corg) must not exceed the limits set out in the following table:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
Where:
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:
(a) cadmium (Cd): 1,5 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) mercury (Hg): 1 mg/kg dry matter,
(d) nickel (Ni): 50 mg/kg dry matter,
(e) lead (Pb): 120 mg/kg dry matter, and
(f) inorganic arsenic (As): 40 mg/kg dry matter.
2a.By derogation from point 2(d), the limit value for nickel (Ni) in a growing medium totally composed by mineral constituents and offered for professional use in horticulture, green roofs or green walls, shall apply to the bioavailable content of the contaminant.
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:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
Where:
An inhibitor shall be an EU fertilising product the function of which is to improve the nutrient release patterns of a product providing plants with nutrients by delaying or stopping the activity of specific groups of micro-organisms or enzymes.
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:
(a) ammoniacal nitrogen (NH3-N) disappearance, or
(b) the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time.
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:
(a) nutrient use efficiency,
(b) tolerance to abiotic stress,
(c) quality traits, or
(d) availability of confined nutrients in the soil or rhizosphere.
2.Contaminants in a plant biostimulant must not exceed the following limit values:
(a) cadmium (Cd): 1,5 mg/kg dry matter,
(b) hexavalent chromium (Cr VI): 2 mg/kg dry matter,
(c) lead (Pb): 120 mg/kg dry matter,
(d) mercury (Hg): 1 mg/kg dry matter,
(e) nickel (Ni): 50 mg/kg dry matter, and
(f) inorganic arsenic (As): 40 mg/kg dry matter.
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:
| Micro-organisms/their toxins, metabolites | Sampling plans | Limit | |
|---|---|---|---|
| n | c | ||
| Salmonella spp. | 5 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli | 5 | 0 | Absence in 1 g or 1 ml |
| Listeria monocytogenes | 5 | 0 | Absence in 25 g or 25 ml |
| Vibrio spp. | 5 | 0 | Absence in 25 g or 25 ml |
| Shigella spp. | 5 | 0 | Absence in 25 g or 25 ml |
| Staphylococcus aureus | 5 | 0 | Absence in 25 g or 25 ml |
| Enterococci | 5 | 2 | 10 CFU/g |
| Anaerobic plate count unless the microbial plant biostimulant is an aerobic bacterium | 5 | 2 | 105 CFU/g or ml |
| Yeast and mould count unless the microbial plant biostimulant is a fungus | 5 | 2 | 1 000 CFU/g or ml |
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:
| Micro-organisms to be tested | Sampling plans | Limit | ||
|---|---|---|---|---|
| n | c | m | M | |
| Salmonella spp. | 5 | 0 | 0 | Absence in 25 g or 25 ml |
| Escherichia coli or enterococci | 5 | 5 | 0 | 1 000 in 1 g or 1 ml |
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.
2a.An inhibiting compound in a blend shall be present in a concentration, which is within the range of concentrations that ensures the achievement of the reduction rates in the conditions referred to in PFC 5 in Part II of this Annex and, respectively, in point 4 of CMC 1 in Part II of Annex II, at the level of the blend.
The manufacturer of the blend shall assess the conformity of the blend with the requirements set out in points 1, 2 and 2a 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:
(a) drawing up an EU declaration of conformity for the fertilising product blend in accordance with Article 6(2) of this Regulation, and
(b) being in possession of the EU declaration of conformity of each of the component EU fertilising products.
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:
(a) Article 6(3) (manufacturers’ obligation to keep the EU declaration of conformity);
(b) point (a) of Article 7(2) (authorised representatives’ obligation to keep the EU declaration of conformity);
(c) Article 8(8) (importers’ obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities).
ANNEX II
Component Material Categories (CMCs)
An EU fertilising product shall consist solely of component materials complying with the requirements for one or more of the CMCs listed in this Annex.
The component materials, and the input materials used to produce them, shall not contain any of the substances for which maximum limit values are indicated in Annex I in such quantities as to jeopardise the EU fertilising product’s compliance with the applicable requirements of that Annex.
PART I
DESIGNATION OF CMCS
CMC 1: Virgin material substances and mixtures
CMC 2: Plants, plant parts or plant extracts
CMC 3: Compost
CMC 4: Fresh crop digestate
CMC 5: Digestate other than fresh crop digestate
CMC 6: Food industry by-products
CMC 7: Micro-organisms
CMC 8: Nutrient polymers
CMC 9: Polymers other than nutrient polymers
CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009
CMC 11: By-products within the meaning of Directive 2008/98/EC
CMC 12: Precipitated phosphate salts and derivates
CMC 13: Thermal oxidation materials and derivates
CMC 14: Pyrolysis and gasification materials
CMC 15: Recovered high purity materials
PART II
REQUIREMENTS RELATED TO CMCS
This Part defines the component materials of which EU fertilising products shall solely consist.
1.An EU fertilising product may contain substances and mixtures, except (4):
(a) waste within the meaning of Directive 2008/98/EC,
(b) substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC,
(c) substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances,
(d) by-products within the meaning of Directive 2008/98/EC,
(e) animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,
(f) polymers, other than: — polymers that are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted and that have not been chemically modified within the meaning of Article 3(40) of Regulation (EC) No 1907/2006, — biodegradable polymers, or — polymers with a water-solubility higher than 2 g/L in the following conditions: — temperature 200 C — pH 7 — loading: 10 g/1 000 mL — test time: 24h,
(g) compost, —————
(h) digestate,
(i) precipitated phosphate salts or derivates, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC,
(j) thermal oxidation materials or derivates which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC, —————
(k) pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC , or
(l) ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC.
2.All substances incorporated into the EU fertilising product, on their own or in a mixture, except polymers, shall have been registered pursuant to Regulation (EC) No 1907/2006 (5), with a dossier containing:
(a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006;
(b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,
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, 9 or 10 (only for magnesia) 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:
(a) The chelating agent shall be an organic substance consisting in a molecule which: (i) has two or more sites that donate electron pairs to a central transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn), magnesium (Mg), calcium (Ca) or cobalt (Co)), and (ii) is large enough to form a five- or six- membered cyclic structure. The EU fertilising product shall remain stable for at least 3 days in a solution having any pH within the range declared as guaranteeing acceptable stability.
(b) The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)). The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day.
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 a nitrification, a denitrification or a urease inhibiting compound, and the following rules shall apply:
(a) The nitrification inhibiting compound shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) contained in the EU fertilising product to nitrite nitrogen (NO2 -), thus slowing the formation of nitrate nitrogen (NO3 -). The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by either of the following: (i) ammoniacal nitrogen (NH3-N) disappearance; (ii) the sum of nitrite nitrogen (NO2 -) and nitrate nitrogen (NO3 -) production with respect to time. Compared to a control sample where the nitrification inhibiting compound has not been added, a soil sample containing the nitrification inhibiting compound 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. The nitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction. At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) forms ammonium (NH4 +) and urea (CH4N2O).
(b) The denitrification inhibiting compound shall inhibit the formation of nitrous oxide (N2O) contained in the EU fertilising product by slowing down or blocking the conversion of nitrate (NO3 -) to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A). Compared to a control sample where the denitrification inhibiting compound has not been added, an in vitro test containing the denitrification inhibiting compound 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. The denitrification inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction.
(c) The urease inhibiting compound shall inhibit hydrolytic action on urea (CH4N2O) contained in the EU fertilising product by the urease enzyme, primarily targeted to reduce ammonia volatilisation. Compared to a control sample where the urease inhibiting compound has not been added, an in vitro test containing the urease inhibiting compound 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. The urease inhibiting compound shall be present in the EU fertilising product in a concentration, which is within the range of concentrations that ensures the achievement of such a reduction. At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O).
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