CELEX: 
Language: en
Date: 2022-02-09
Title: COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the requirements applicable to EU fertilising products containing inhibiting compounds and the post-processing of digestate

EXPLANATORY MEMORANDUM
            
            
               1.CONTEXT OF THE DELEGATED ACT
            
            
               Regulation (EU) 2019/1009 of the European Parliament and of the Council
                  1
                lays down rules on the making available on the market of EU fertilising products. It repeals Regulation (EC) No 2003/2003 of the European Parliament and of the Council
                  2
                as of 16 July 2022. 
            
            
               Regulation (EU) 2019/1009 lays down harmonisation rules for various categories of fertilising products. This Regulation lays down radically different harmonisation rules for inorganic fertilisers already regulated under varied types of EC fertilisers in Regulation (EC) No 2003/2003. It also lays down harmonisation rules for extensive categories of products, which are not yet subject to harmonisation rules, such as organic and organo-mineral fertilisers, soil improvers or growing media.
            
            
               While preparing the transition to the new harmonisation rules, both Member States and interested stakeholders informed the Commission on the need to adapt some technical provisions in the annexes to Regulation (EU) 2019/1009. Part of these adaptations have already been introduced by Commission Delegated Regulation (EU) 2021/1768
                  3
               . 
            
            
               Certain adaptations are necessary to facilitate internal market access for fertilising products that are agronomically efficient, safe and already widely traded on the market. Some of those amendments facilitate the free movement of such products, by improving the consistency with other legal acts and policy objectives of the Union. Other amendments are necessary in order to avoid situations in which significant categories of fertilising products would inadvertently be excluded from the harmonisation rules.
            
            
               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
            
            
               Member States were consulted in the Commission expert group on Fertilising Products (E01320) according to the rules of the Interinstitutional Agreement on Better Law-Making of 13 April 2016
                  4
                .
            
            
               Details of these consultations can be found in the minutes of the meetings held on 22-23 November 2021 (…), as well as in the various position papers of interested stakeholders publicly available on the CIRCABC page of the group, at the following link:
            
            
               https://circabc.europa.eu/ui/group/36ec94c7-575b-44dc-a6e9-4ace02907f2f/library/b8e01334-4d39-445d-bf4e-589356d55b1f 
            
            
               Member States and interested stakeholders were largely supportive of the adoption of this delegated Regulation.
            
            
               The draft delegated Regulation has been published for feedback on the Better Regulation portal. (to add details)
            
            
               The draft delegated Regulation has also been notified based on Article 2(9)(2) of the Agreement on Technical Barriers to Trade. (to add details) 
            
            
               3.LEGAL ELEMENTS OF THE DELEGATED ACT
            
            
               The delegated act amends technical provisions in Annexes I, II, III and IV to Regulation (EU) 2019/1009. The legal basis of this delegated act is Article 42(1) of Regulation (EU) 2019/1009.
            
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
            
               amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the requirements applicable to EU fertilising products containing inhibiting compounds and the post-processing of digestate
            
            
               THE EUROPEAN COMMISSION,
            
         
         
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003
                  5
               , and in particular Article 42(1) thereof,
            
            
               Whereas:
            
            
               (1)A fertilising product, which meets the requirements laid down in Annexes I and II to Regulation (EU) 2019/1009 for the relevant product function category (‘PFC’) and component material category (‘CMC’) respectively, is labelled in accordance with Annex III to that Regulation and has successfully passed the conformity assessment procedure laid down in Annex IV to Regulation (EU) 2019/1009, can then be CE marked and can move freely in the internal market as an EU fertilising product.  
            
            
               (2)While preparing for the transition to new harmonisation rules, both Member States and interested stakeholders informed the Commission about the need to adapt some of the technical provisions in the annexes to Regulation (EU) 2019/1009. Those adaptations are necessary to facilitate internal market access for fertilising products that are agronomically efficient, safe and already widely traded on the market. Some of those amendments facilitate the free movement such products, i.e. safe and agronomically efficient fertilising products, by improving the consistency with other legal acts and policy objectives of the Union. Other amendments are necessary in order to avoid situations in which significant categories of fertilising products would inadvertently be excluded from the harmonisation rules. 
            
            
               (3)Regulation (EU) 2019/1009, as amended by Commission Delegated Regulation (EU) 2021/1768
                  6
                allows manufacturers to use certain types of polymers in EU fertilising products if those are compliant with the conditions laid down for CMC 1 and CMC 11 in Annex II to that Regulation. One of the conditions is that the polymer is registered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  7
               . In the Communication titled ‘Chemicals Strategy for Sustainability, towards a Toxic-Free Environment’
                  8
               , the Commission announced the revision of Regulation (EC) No 1907/2006 [reminder: update if needed], extending a registration obligation to certain polymers. Consequently, for reasons of coherence and consistency, the registration obligation of polymers should, as a first step, be regulated under Regulation (EC) No 1907/2006, as the discussions for its revision offers a broader context and the possibility of taking a holistic approach, before being included in Regulation (EU) 2019/1009.
            
            
               (4)Regulation (EU) 2019/1009 lays down an obligation for the registration of magnesia in accordance with Regulation (EC) No 1907/2006. However, Regulation (EC) No 1907/2006 exempts magnesia, which is not chemically modified, from the registration obligation, as the registration is deemed inappropriate or unnecessary for that substance and its exemption from the registration obligation does not jeopardise the objectives of that Regulation. Magnesia has a long history of use in fertilisers and has no harmonised classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council
                  9
               . Taking that into account and in order to facilitate the access to the internal market of fertilisers containing magnesia as EU fertilising products, the registration obligation laid down in Regulation (EU) 2019/1009 should no longer apply to magnesia used in fertilisers.
            
            
               (5)Regulation (EU) 2019/1009 lays down requirements for inhibitors as EU fertilising products belonging to PFC 5 and for EU fertilising products containing inhibitors as a component material belonging to CMC 1. To avoid any confusions, the terminology used in that Regulation should be amended to reflect the distinction between the two situations. Thus, the term ‘inhibiting compound’ should be used whenever it concerns a substance or mixture which improve the nutrient release pattern of a nutrient by delaying or stopping the activity of specific groups of micro-organisms or enzyme. The term “inhibitor” should be used only when it refers to EU fertilising products belonging to PFC 5. This distinction is important as inhibitors may be mixtures containing other substances, like stabilisers, in addition to inhibiting compounds. Correct use of those terms is necessary to facilitate the free movement of EU fertilising products, by clearly laying down the rules applicable in each situation. 
            
            
               (6)Regulation (EU) 2019/1009 includes requirements ensuring that the inhibiting compounds are efficient, but does not lay down requirements on the efficiency of fertiliser or the blend containing such an inhibiting compound. The use of efficient products containing such substances helps avoiding the environmental pollution caused by the leaching of nitrogen. Commission Communications titled ‘Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil’
                  10
                and ‘A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system’
                  11
                mention the environmental concerns and the ambitious targets to reduce nutrient losses by 50% by 2030. It is therefore important to ensure that the EU fertilising products, which contain inhibiting compounds, are efficient. Therefore, Regulation (EU) 2019/1009 should be amended to include a requirement that inhibiting compounds are present in fertilisers (PFC 1) in a concentration that ensures the efficiency of such fertilisers. In addition, the manufacturers should ensure that the blending of EU fertilising products containing inhibiting compounds does not affect the performance of the inhibiting compounds therein. Furthermore, additional labelling requirements should ensure that the manufacturers of inhibitors referred to in PFC 5 provide clear instructions on how to mix such products with a fertiliser to ensure their efficiency. 
            
            
               (7)Regulation (EU) 2019/1009 lays down rules on the use of fresh crop digestate and on digestate other than fresh crop digestate, hereafter commonly referred to as ‘digestate’, as component materials in EU fertilising products. That Regulation lays down rules for the digestion processes. However, it does not provide for any other rules for post processing of the digestate. 
            
            
               (8)The Joint Research Centre (JRC) report titled ‘End-of-waste criteria for biodegradable waste subjected to biological treatment (compost & digestate): Technical proposals’
                  12
                states that digestate is often used in agriculture, either as a whole  or following separation in a solid and liquid fraction. That separation facilitates the storing of materials and their long-distance transport, which is especially important for a CE marked product. The mechanical separation of the solid and liquid fractions of a digestate is a commonly used method in some Member States and seems to be a well-established method according to a recent study titled ‘Digestate and compost as fertilisers: Risk assessment and risk management options’
                  13
               . The separation of the solid and liquid fraction of a digestate could pose limited risks if conditions regarding the post digestion process and the additives to be used are laid down. Therefore, Regulation (EU) 2019/1009 should be amended to include this post digestion process, under the conditions that the additives used do not exceed a certain concentration and are registered in accordance with Regulation (EC) No 1907/2006. Allowing these processes in Regulation (EU) 2019/1009 is necessary in order to facilitate the access to the internal market of EU fertilising products containing digestate and adapt the requirements laid down for these component material categories to technical progress. It will also create new opportunities for the recovery of bio-waste, which is in line with the overall ambitious plans for a circular economy. 
            
            
               (9)Besides the mechanical separation of the solid and liquid fractions of a digestate, other processes are commonly used to remove water from a digestate or its fractions. Regulation (EU) 2019/1009 should allow manufacturers to further process the digestate or its fractions in order to extract water, as long as these processes do not chemically modify the materials. Furthermore, nitrogen may be recovered out of a digestate via stripping. To close the loop, it is important not only to create the possibility for the recovery of nitrogen out of digestate, ending up with a high purity material, but also to allow for the use of the remaining digestate in EU fertiliting products, given that it contains various other nutrients and organic matter. 
            
            
               (10)Regulation (EU) 2019/1009 applies without prejudice to Regulation (EU) 2019/1021 of the European Parliament and of the Council
                  14
               , which lays down general rules applicable to persistent organic pollutants. Regulation (EU) 2019/1009 lays down a limit-value of 0.8 mg/kg dry matter of ndl-PCB for pyrolysis and gasification materials belonging to CMC 14. However, in accordance with Regulation (EU) 2019/2021, PCB are not to be present in substances or mixtures placed on the EU market. To ensure coherence with Regulation (EU) 2019/1021 and clarity as to the fact that no ndl-PCB is to be contained in EU fertilising products with pyrolysis or gasification materials, that limit value in Regulation (EU) 2019/1009 should be deleted. 
            
            
               (11)In accordance with Regulation (EU) 2019/1009, EU fertilising products containing micro-organisms as specified in CMC 7 may be subject to the conformity assessment procedure described in Module A, Internal production control. Such micro-organisms are contained in microbial plant biostimulants. In accordance with that Regulation, the conformity assessment of plant biostimulants cannot be done following Module A. To facilitate the free movement on the internal market of such products by avoiding any confusion on the applicable conformity assessment procedure, the erroneous reference to micro-organisms in the rules concerning the applicability of that Module should be deleted.  
            
            
               (12)Regulation (EU) 2019/1009 should therefore be amended accordingly, 
            
            
                
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Regulation (EU) 2019/1009 is amended as follows:
            
            
               (1)Annex I is amended in accordance with Annex I to this Regulation;
            
         
         
            
               (2)Annex II is amended in accordance with Annex II to this Regulation;
            
            
               (3)Annex III is amended in accordance with Annex III to this Regulation;
            
            
               (4)Annex IV is amended in accordance with Annex IV to this Regulation.
            
            
               Article 2 
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Ursula von der Leyen
                  
            
         
         
      
    ---documentbreak--- 
      
         
         
            
               ANNEX I
            
            
               Part II of Annex I to Regulation (EU) 2019/1009 is amended as follows:
            
            
               (1)in point 2 of PFC 1(C), the second indent is replaced by the following: 
            
            
               ‘- nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II,’;
            
            
               (2)Section ‘PFC 7’ is amended as follows:
            
            
               (a)the following point 2a is inserted: 
            
            
               ‘2a. An inhibiting compound in a blend shall lead to the reduction rates 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.’,
            
            
               (b)the introductory sentence in point 3 is replaced by the following:
            
            
               ‘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:’.
            
            
                
               
            
               ANNEX II
            
            
               Part II of Annex II to Regulation (EU) 2019/1009 is amended as follows:
            
            
               (1)Section  ‘CMC 1’ is amended as follows:
            
            
               (a)point 2 is replaced by the following: 
            
            
               ‘2. All substances incorporated into the EU fertilising product, on their own or in a mixture, except the polymers referred to in point 1(f), shall have been registered pursuant to Regulation (EC) No 1907/2006, 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.’.,
            
            
               (b)point 4 is replaced by the following:
            
         
         
            
               ‘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 (NO-) 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 that ensures 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 that ensures 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 that ensures 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).’; 
            
            
               (2)Section  ‘CMC 4’ is amended as follows: 
            
            
               (a)the following points 3a, 3b and 3c are inserted:
            
            
               ‘3a. An EU fertilising product may contain a solid or liquid fraction of digestate, provided that all of the following conditions are met: 
            
            
               (a)the solid or liquid fraction is obtained by mechanical separation of digestate compliant with points 1 to 3; 
            
         
         
            
               (b) the additives needed for the mechanical separation comply with the requirement in point 1(b)(i);
            
            
               (c) the total concentration of all additives does not exceed 5 % of the digestate weight.
            
            
               3b. An EU fertilising product may contain a digestate compliant with points 1 to 3, or a fraction compliant with point 3a, from which all or part of the soluble ammonium has been removed to recover nitrogen, without the intention to otherwise modify the digestate or the fraction.
            
            
               3c. An EU fertilising product may contain a digestate compliant with points 1 to 3 or point 3b, as well as a fraction compliant with point 3a, which have undergone only physical processing to remove water that does not chemically modify the digestate or the fraction.’,
            
            
               (b)in point 4, the introductory sentence is replaced by the following:
            
            
               ‘The digestate or a fraction referred to in points 3a or 3c shall meet at least one of the following stability criteria:’;
            
            
               (1)Section ‘CMC 5’ is amended as follows:
            
            
               (a)the following points 3a, 3b and 3c are inserted:
            
            
               ‘3a. An EU fertilising product may contain a solid or liquid fraction of digestate, provided that all of the following conditions are met: 
            
            
               (a)the solid or liquid fraction is obtained by mechanical separation of digestate compliant with points 1 to 3; 
            
            
               (b) the additives needed for the mechanical separation comply with the requirement in point 1(d)(i);
            
            
               (c)the total concentration of all additives does not exceed 5 % of the digestate weight.
            
            
               3b. An EU fertilising product may contain a digestate compliant with points 1 to 3, or a fraction referred to in [compliant with? See above] point 3a, from which all or part of the soluble ammonium has been removed to recover nitrogen, without the intention to otherwise modify the digestate or the fraction.
            
            
               3c. An EU fertilising product may contain a digestate compliant with points 1 to 3 or point 3b, as well as a fraction compliant with point 3a, which have undergone only physical processing to remove water that do not chemically modify the digestate or the fraction.’,
            
            
               (b)point 4 is replaced by the following:
            
            
               ‘4. The digestate or the fraction referred to in points 3a and 3c shall not contain more than 6 mg/kg dry matter of PAH16.’,
            
            
               (c)in point 5, the introductory sentence is replaced by the following:
            
            
               ‘The digestate or the fraction referred to in points 3a and 3c shall contain:’,
            
            
               (d)in point 6, the introductory sentence is replaced by the following:
            
            
               ‘The digestate or the fraction referred to in points 3a and 3c shall meet at least one of the following stability criteria:’;
            
         
         
            
               (1)in Section ‘CMC 11’, point 2 is replaced by the following:
            
            
               ‘2. The by-products, except the polymers referred to in point 1(b), shall have been registered pursuant to Regulation (EC) No 1907/2006, 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.’;
            
            
               (2)in point 3 of Section ‘CMC 14’ sub-point (c) is deleted.
            
            
               ANNEX III
            
            
               Part II of Annex III to Regulation (EU) 2019/1009 is amended as follows:
            
            
               (1)Section ‘PFC 1’ is amended as follows:
            
            
               (a)point 3 is replaced by the following:
            
            
            
               ‘3. The following rules apply to fertilisers containing inhibiting compounds, as specified in CMC 1 in Part II of Annex II:
            
            
               (a)the label shall state the words ‘nitrification inhibitor’, ‘denitrification inhibitor’ or ‘urease inhibitor’, as relevant;
            
            
               (b)the nitrification inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4 +) and urea nitrogen (CH4N2O);
            
            
               (c)the denitrification inhibiting compound content shall be expressed as a % by mass of the nitrate (NO3-) present;
            
            
               (d)the urease inhibiting compound content shall be expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O);
            
            
               (e)The use instructions referred to in Part I, point 1(d), of this Annex shall include information on the conditions of use which could influence the efficiency of the inhibiting compound.’,
            
            
               (b) in point 4(a), point (ii) is replaced by the following:
            
            
               ‘(ii) nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 1 in Part II of Annex II,’;
            
            
               (2)Section ‘PFC 5: INHIBITOR’ is replaced by the following:
            
         
         
            
               ‘PFC 5: INHIBITOR
            
            
               1.All ingredients shall be declared by product weight or volume in descending order of magnitude.
            
            
               2.The content of the inhibiting compound(s) as % by mass or volume shall be declared. 
            
            
               3.The use instructions referred to in Part I, point 1(d), of this Annex shall ensure that the inhibitor leads to the reduction rates referred to in PFC 5 in Part II of Annex I, by providing information on:
            
            
               (a)the types of EU fertilising products with which the inhibitor may be mixed; 
            
            
               (b)the minimum and maximum recommended concentration of inhibiting compound(s) when mixed with a fertiliser prior to its use:
            
            
               (i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I , as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4 +) and urea nitrogen (CH4N2O);
            
            
               (ii) for the denitrification inhibitor referred to in PFC 5(B) in Part II of Annex I, as a % by mass of the nitrate (NO3-) present;
            
            
               (iii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O);
            
            
               (c)the conditions of use which could affect the efficiency of the inhibitor.’
            
            
            
               In Part III of Annex III, Section ‘PFC 1: FERTILISER’ is replaced by the following:
            
            
               ‘PFC 1: FERTILISER
            
            
               The following tolerance rules apply to fertilisers containing nitrification, denitrification or urease inhibiting compounds, as specified in CMC 1 in Part II of Annex II:
            
            
                     
                        Inhibiting compounds
                     
                  
                  
                     
                        Permissible tolerance for the declared content of inhibiting compounds
                     
                  
               
                     
                        Concentration below or equal to 2 %
                     
                  
                  
                     
                        ± 20 % of the declared value
                     
                  
               
                     
                        Concentration of more than 2 %
                     
                  
                  
                     
                        ± 0,3 percentage points in absolute terms’
                     
                  
               
                 
            
            
               ANNEX IV
            
            
               Part I of Annex IV to Regulation (EU) 2019/1009 is amended as follows:
            
            
               (1)point 1.1 is amended as follows:
            
            
               (a)sub-point (a) is replaced by the following:
            
         
         
            
               ‘(a) virgin material substances or mixtures as specified in CMC 1 in Part II of Annex II, except a nitrification, a denitrification or a urease inhibiting compound,’,
            
            
               (b)sub-point (d) is deleted. ; 
            
            
               (2)in point 3.1, sub-point (a) is replaced by the following:
            
            
               ‘(a) nitrification, denitrification or urease inhibiting compound as specified in CMC 1 in Part II of Annex II,’.