Legal provisions of COM(2001)508 - Fertilizers - Main contents
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dossier | COM(2001)508 - Fertilizers. |
---|---|
document | COM(2001)508 |
date | October 13, 2003 |
Contents
- TITLE I - GENERAL PROVISIONS
- CHAPTER I - Scope and definitions
- Article 1 - Scope
- Article 2 - Definitions
- CHAPTER II - Placing on the market
- Article 3 - EC Fertiliser
- Article 4 - Establishment within the Community
- Article 5 - Free circulation
- Article 6 - Compulsory statements
- Article 7 - Identification
- Article 8 - Traceability
- Article 9 - Markings
- Article 10 - Labelling
- Article 11 - Languages
- Article 12 - Packaging
- Article 13 - Tolerances
- Article 14 - Fertiliser requirements
- Article 15 - Safeguard clause
- TITLE II - PROVISIONS FOR SPECIFIC TYPES OF FERTILISERS
- CHAPTER I - Inorganic primary nutrient fertilisers
- Article 16 - Scope
- Article 17 - Declaration of secondary nutrients in primary nutrient fertilisers
- Article 18 - Calcium, magnesium, sodium and sulphur
- Article 19 - Identification
- CHAPTER II - Inorganic secondary nutrient fertilisers
- Article 20 - Scope
- Article 21 - Identification
- CHAPTER III - Inorganic micro-nutrient fertilisers
- Article 22 - Scope
- Article 23 - Identification
- Article 24 - Packaging
- CHAPTER IV - Ammonium nitrate fertilisers of high nitrogen content
- Article 25 - Scope
- Article 26 - Safety measures and controls
- Article 27 - Test of resistance to detonation
- Article 28 - Packaging
- TITLE III - CONFORMITY ASSESSMENT OF FERTILISERS
- Article 29 - Control measures
- Article 30 - Laboratories
- TITLE IV - FINAL PROVISIONS
- CHAPTER I - Adaptation of the Annexes
- Article 31 - New EC fertilisers
- Article 32 - Committee procedure
- CHAPTER II - Transitional provisions
- Article 33 - Competent laboratories
- Article 34 - Packaging and labelling
- CHAPTER III - Final provisions
- Article 35 - Repealed Directives
- Article 36 - Penalties
- Article 37 - National provisions
- Article 38 - Entry into force
TITLE I - GENERAL PROVISIONS
CHAPTER I - Scope and definitions
Article 1 - Scope
Article 2 - Definitions
(a) 'Fertiliser' means material, the main function of which is to provide nutrients for plants.
(b) 'Primary nutrient' means the elements nitrogen, phosphorus and potassium only.
(c) 'Secondary nutrient' means the elements calcium, magnesium, sodium and sulphur.
(d) 'Micro-nutrients' means the elements boron, cobalt, copper, iron, manganese, molybdenum and zinc, essential for plant growth in quantities that are small compared with those of primary and secondary nutrients.
(e) 'Inorganic fertiliser' means a fertiliser in which the declared nutrients are in the form of minerals obtained by extraction or by physical and/or chemical industrial processes. Calcium cyanamide, urea and its condensation and association products, and fertilisers containing chelated or complexed micro-nutrients may, by convention, be classed as inorganic fertilisers.
(f) 'Chelated micro-nutrient' means a micro-nutrient that is held by one of the organic molecules listed in section E.3.1 of Annex I.
(g) 'Complexed micro-nutrient' means a micro-nutrient that is held by one of the molecules listed in section E.3.2 of Annex I.
(h) 'Type of fertilisers' means fertilisers with a common type designation as indicated in Annex I.
(i) 'Straight fertiliser' means a nitrogenous, phosphatic or potassic fertiliser having a declarable content of only one of the primary nutrients.
(j) 'Compound fertiliser' means a fertiliser having a declarable content of at least two of the primary nutrients and obtained chemically or by blending or by a combination of both.
(k) 'Complex fertiliser' means a compound fertiliser, obtained by chemical reaction, by solution, or in its solid state by granulation, having a declarable content of at least two of the primary nutrients. In its solid state each granule contains all the nutrients in their declared composition.
(l) 'Blended fertiliser' means a fertiliser obtained by dry mixing of several fertilisers, with no chemical reaction.
(m) 'Foliar fertiliser' means a fertiliser suitable for application to and nutrient uptake by the foliage of a crop.
(n) 'Fluid fertiliser' means a fertiliser in suspension or solution.
(o) 'Solution fertiliser' means a fluid fertiliser that is free of solid particles.
(p) 'Suspension fertiliser' means a two-phase fertiliser in which solid particles are maintained in suspension in the liquid phase.
(q) 'Declaration' means a statement of the amount of nutrients, including their forms and solubility, guaranteed within specified tolerances.
(r) 'Declared content' means the content of an element, or its oxide, which, in accordance with Community legislation, is given on a label of an EC fertiliser or on the relevant accompanying document.
(s) 'Tolerance' means the permitted deviation of the measured value of a nutrient content from its declared value.
(t) 'European Standard' means CEN (European Committee for Standardisation) standards, which have been officially recognised by the Community and whose reference has been published in the Official Journal of the European Communities.
(u) 'Package' means a sealable receptacle used to hold, protect, handle, and distribute fertilisers and holding not more than 1000 kg.
(v) 'Bulk' means a fertiliser not packaged as prescribed by this Regulation.
(w) 'Placing on the market' means the supply of fertiliser, whether in return for payment or free of charge, or storage for the purpose of supply. Importation of a fertiliser into the customs territory of the European Community shall be deemed to constitute placing on the market.
(x) 'Manufacturer' means the natural or legal person responsible for placing a fertiliser on the market; in particular a producer, an importer, a packager working for its own account, or any person changing the characteristics of a fertiliser, shall be deemed to be a manufacturer. However, a distributor who does not change the characteristics of the fertiliser shall not be deemed to be a manufacturer.
CHAPTER II - Placing on the market
Article 3 - EC Fertiliser
The designation 'EC fertiliser' shall not be used for a fertiliser which does not comply with this Regulation.
Article 4 - Establishment within the Community
Article 5 - Free circulation
2. Fertilisers that are marked 'EC fertiliser' in accordance with this Regulation shall circulate freely within the Community.
Article 6 - Compulsory statements
(a) nitrogen solely in the elemental form (N); and either
(b) phosphorus and potassium solely in the elemental form (P, K); or
(c) phosphorus and potassium solely in the oxide form (P2O5, K2O); or
(d) phosphorus and potassium in both elemental and oxide forms simultaneously.
Where the option is chosen to prescribe that the phosphorus and potassium contents be expressed in the form of elements, all references in the Annexes to the oxide form shall be read as being in elemental form and the numerical values shall be converted using the following factors:
(a) phosphorus (P) = phosphorus pentoxide (P2O5) × 0,436;
(b) potassium (K) = potassium oxide (K2O) × 0,830.
2. Member States may prescribe that the calcium, magnesium, sodium and sulphur contents of secondary nutrient fertilisers and, where the conditions of Article 17 are fulfilled, of primary nutrient fertilisers placed on their markets are to be expressed:
(a) in the oxide form (CaO, MgO, Na2O, SO3); or
(b) in the elemental form (Ca, Mg, Na, S); or
(c) in both of these forms.
To convert the calcium oxide, magnesium oxide, sodium oxide and sulphur trioxide contents into calcium, magnesium, sodium and sulphur contents, the following factors shall be used:
(a) calcium (Ca) = calcium oxide (CaO) × 0,715;
(b) magnesium (Mg) = magnesium oxide (MgO) × 0,603;
(c) sodium (Na) = sodium oxide (Na2O) × 0,742;
(d) sulphur (S) = sulphur trioxide (SO3) × 0,400.
For the calculated oxide or elemental content, the figure declared shall be rounded to the nearest decimal place.
3. Member States shall not prevent the placing on the market of an 'EC fertiliser' labelled in both of the forms mentioned in paragraphs 1 and 2.
4. The content of one or more of the micro-nutrients boron, cobalt, copper, iron, manganese, molybdenum, or zinc in the EC fertilisers belonging to the types of fertilisers listed in sections A, B, C and D of Annex I shall be declared where the following conditions are fulfilled:
(a) the micro-nutrients are added at least in the minimum quantities specified in section E.2.2 and E.2.3 of Annex I;
(b) the EC fertiliser continues to satisfy the requirements of sections A, B, C and D of Annex I.
5. Where the micro-nutrients are the normal ingredients of the raw materials intended to supply primary (N, P, K) and secondary (Ca, Mg, Na, S) nutrients, they may be declared, provided that these micro-nutrients are present at least in the minimum quantities specified in sections E.2.2 and E.2.3 of Annex I.
6. The micro-nutrient content shall be declared in the following manner:
(a) for fertilisers belonging to the types of fertilisers listed in section E.1 of Annex I, in accordance with the requirements set out in column 6 of that section;
(b) for mixtures of fertilisers referred to in (a) containing at least two different micro-nutrients and meeting the requirements of section E.2.1 of Annex I and for fertilisers belonging to the types of fertilisers listed in sections A, B, C and D of Annex I, by indicating:
(i) the total content, expressed as a percentage of the fertiliser by mass,
(ii) the water-soluble content, expressed as a percentage of the fertiliser by mass, where the soluble content is at least half of the total content.
Where a micro-nutrient is totally water-soluble, only the water-soluble content shall be declared.
Where a micro-nutrient is chemically linked with an organic molecule, the content of the micro-nutrient present in the fertiliser shall be declared immediately following the water-soluble content as a percentage by mass of the product, followed by one of the terms 'chelated by', or 'complexed by', with the name of the organic molecule as set out in section E.3 of Annex I. The name of the organic molecule may be replaced by its initials.
Article 7 - Identification
2. If the fertilisers are packed, these identification markings shall appear on the packages or labels attached. If the fertilisers are in bulk, these markings shall appear on the accompanying documents.
Article 8 - Traceability
Article 9 - Markings
(a) Compulsory identification
- The words 'EC FERTILISER' in capital letters;
- Where it exists, the designation of the type of fertiliser as set out in Annex 1;
- For blended fertilisers, the marking 'blend' after the designation of the type;
- The additional markings specified in Article 19, 21 or 23;
- Nutrients shall be indicated both in words and by the appropriate chemical symbols, e.g. nitrogen (N), phosphorus (P), phosphorus pentoxide (P2O5), potassium (K), potassium oxide (K2O), calcium (Ca), calcium oxide (CaO), magnesium (Mg), magnesium oxide (MgO), sodium (Na), sodium oxide (Na2O), sulphur (S), sulphur trioxide (SO3), boron (B), copper (Cu), cobalt (Co), iron (Fe), manganese (Mn), molybdenum (Mo), zinc (Zn);
- If the fertiliser contains micro-nutrients of which all or part are chemically linked with an organic molecule, the name of the micro-nutrient shall be followed by one of the following qualifiers:
(i) 'chelated by ...' (name of chelating agent or its abbreviation as set out in section E.3.1 of Annex I);
(ii) 'complexed by ...' (name of complexing agent as set out in section E.3.2 of Annex I);
- Micro-nutrients contained in the fertiliser, listed in the alphabetical order of their chemical symbols: B, Co, Cu, Fe, Mn, Mo, Zn;
- For products listed in sections E.1 and E.2 of Annex I, the specific directions for use;
- Quantities of fluid fertilisers, expressed by mass. The expression of quantities of fluid fertilisers by volume or in terms of mass versus volume (kilograms per hectolitre or grams per litre) shall be optional;
- Net or gross mass and, optionally, volume for fluid fertilisers. If the gross mass is given, the tare mass must be indicated beside it;
- The name or trade name and the address of the manufacturer.
(b) Optional identification
- As listed in Annex I;
- The directions for the storage and handling, and for fertilisers not listed in Annex I, sections E.1 and E.2, the specific directions for the use of the fertiliser;
- Indications of the dose rates and conditions of use suitable for the soil and crop conditions under which the fertiliser is used;
- The mark of the manufacturer and the trade description of the product.
The indications referred to in (b) must not conflict with those referred to in (a) and must be clearly separated from them.
2. All the markings referred to in paragraph 1 must be clearly separated from any other information on the packages, labels and accompanying documents.
3. Fluid fertilisers may be placed on the market only if the manufacturer provides suitable additional instructions covering, in particular, storage temperature and prevention of accidents during storage.
4. Detailed rules for the application of this Article shall be adopted under the procedure referred to in Article 32(2).
Article 10 - Labelling
2. The markings referred to in paragraph 1 must be and must remain indelible and clearly legible.
3. In the cases of fertilisers in bulk referred to in the second sentence of Article 7(2) a copy of the documents containing the identification markings must accompany the goods and be accessible for inspection purposes.
Article 11 - Languages
Article 12 - Packaging
Article 13 - Tolerances
2. The manufacturer shall not take systematic advantage of the tolerances given in Annex II.
3. No tolerances are allowed in respect of the minimum and maximum contents specified in Annex I.
Article 14 - Fertiliser requirements
(a) it provides nutrients in an effective manner;
(b) relevant sampling, analysis, and if required, test methods are being provided.
(c) under normal conditions of use it does not adversely affect human, animal, or plant health, or the environment.
Article 15 - Safeguard clause
2. The Commission shall adopt a decision on the matter within 90 days from the receipt of the information in accordance with the procedure referred to in Article 32(2).
3. The provisions of this Regulation shall not preclude the taking of measures by the Commission or by a Member State which are justified on grounds of public security to prohibit, restrict or hinder the placing on the market of EC fertilisers.
TITLE II - PROVISIONS FOR SPECIFIC TYPES OF FERTILISERS
CHAPTER I - Inorganic primary nutrient fertilisers
Article 16 - Scope
Article 17 - Declaration of secondary nutrients in primary nutrient fertilisers
(a) 2 % calcium oxide (CaO), i.e. 1,4 % Ca;
(b) 2 % of magnesium oxide (MgO), i.e. 1,2 % Mg;
(c) 3 % of sodium oxide (Na2O), i.e. 2,2 % Na;
(d) 5 % of sulphur trioxide (SO3), i.e. 2 % S.
In such a case, the additional marking specified in Article 19(2)(ii) shall be added to the type designation.
Article 18 - Calcium, magnesium, sodium and sulphur
(a) the total content expressed as a percentage of the fertiliser by mass;
(b) the total content and the content soluble in water, expressed as a percentage of the fertiliser by mass where the soluble content is at least a quarter of the total content;
(c) where an element is totally soluble in water, only the content soluble in water shall be declared as a percentage of the mass.
2. Unless otherwise stated in Annex I, a declaration of the calcium content shall only be made if it is soluble in water and shall be expressed as a percentage of the fertiliser by mass.
Article 19 - Identification
2. The following shall be stated after the type designation of compound fertilisers:
(i) The chemical symbols of the declared secondary nutrients, between brackets and after the symbols of the primary nutrients.
(ii) Numbers indicating the primary nutrient content. The declared secondary nutrient content shall be indicated between brackets after the primary nutrient content.
3. The fertiliser type designation shall only be followed by figures indicating primary and secondary nutrient content.
4. Where micro-nutrients are declared, the words 'with micro-nutrients' or the word 'with' followed by the name or names and chemical symbols of the micro-nutrients present shall be given.
5. The declared content of primary nutrients and secondary nutrients shall be given as a percentage by mass, as whole numbers or, where necessary, where an appropriate method of analysis exists, to one decimal place.
In fertilisers containing more than one declared nutrient, the order shall be for primary nutrients: N, P2O5 and/or P, K2O and/or K, and for secondary nutrients: CaO and/or Ca, MgO and/or Mg, Na2O and/or Na, SO3 and/or S.
The declared content of micro-nutrients shall give the name and symbol of each micro-nutrient, indicating the percentage by mass as specified in sections E.2.2 and E.2.3 of Annex I and according to solubility.
6. The forms and solubility of the nutrients shall also be expressed as a percentage by mass of fertiliser, except where Annex I explicitly provides that this content shall be otherwise expressed.
The number of decimal places shall be one, except for micro-nutrients where it shall be as specified in sections E.2.2 and E.2.3 of Annex I.
CHAPTER II - Inorganic secondary nutrient fertilisers
Article 20 - Scope
Article 21 - Identification
2. Where micro-nutrients are declared, the words 'with micro-nutrients' or the word 'with', followed by the name or names and chemical symbols of the micro-nutrients present, shall be given.
3. The declared content of secondary nutrients shall be given as a percentage by mass, as whole numbers or, where necessary, where an appropriate method of analysis exists, to one decimal place.
Where more than one secondary nutrient is present, the order shall be:
CaO and/or Ca, MgO and/or Mg, Na2O and/or Na, SO3 and/or S.
The declared content of micro-nutrients shall give the name and symbol of each micro-nutrient, indicating the percentage by mass as specified in sections E.2.2 and E.2.3 of Annex I and according to solubility.
4. The forms and solubility of the nutrients shall also be expressed as a percentage by mass of fertiliser, except where Annex I explicitly provides that this content shall be otherwise expressed.
The number of decimal places shall be one, except for micro-nutrients where it shall be as specified in sections E.2.2 and E.2.3 of Annex I.
5. Unless otherwise stated in Annex I, a declaration of the calcium content shall only be made if it is soluble in water and shall be expressed as a percentage of the fertiliser by mass.
CHAPTER III - Inorganic micro-nutrient fertilisers
Article 22 - Scope
Article 23 - Identification
2. Where the fertiliser contains more than one micro-nutrient, the type designation 'mixture of micro-nutrients' followed by the names of the micro-nutrients present and their chemical symbols, shall be given.
3. For fertilisers containing only one micro-nutrient (section E.1 of Annex I), the declared micro-nutrient content shall be given as a percentage by mass, in whole numbers or, where necessary, to one decimal place.
4. The forms and solubility of micro-nutrients shall be expressed as a percentage by mass of fertiliser, except where Annex I explicitly provides that this content shall be otherwise expressed.
The number of decimal places for micro-nutrients shall be as specified in section E.2.1 of Annex I.
5. Below the compulsory or optional declarations the following shall be entered on the label and accompanying documents with regard to the products appearing in sections E.1 and E.2.1 of Annex I:
"To be used only where there is a recognised need. Do not exceed the appropriate dose rates."
Article 24 - Packaging
CHAPTER IV - Ammonium nitrate fertilisers of high nitrogen content
Article 25 - Scope
This type of fertiliser may contain inorganic or inert substances.
The substances used in the manufacturing of this type of fertiliser must not increase its sensitivity to heat or its tendency to detonate.
Article 26 - Safety measures and controls
2. The checking, analysis and testing for official controls of straight ammonium nitrate fertilisers of high nitrogen content provided for by this chapter shall be carried out in accordance with the methods described in section 3 of Annex III.
3. To ensure the traceability of ammonium nitrate EC fertilisers of high nitrogen content placed on the market, the manufacturer shall maintain records of the names and addresses of the sites, and of the operators of the sites, at which the fertiliser and its principal components were produced. These records shall be available for inspection by Member States for as long as the fertiliser is being supplied to the market, and for a further period of 2 years after the manufacturer stopped supplying it.
Article 27 - Test of resistance to detonation
Article 28 - Packaging
TITLE III - CONFORMITY ASSESSMENT OF FERTILISERS
Article 29 - Control measures
Member States may charge fees not exceeding the cost of tests needed for such control measures, but this shall not oblige manufacturers to repeat tests or to pay for repeated tests where the first test was made by a laboratory which fulfilled the conditions of Article 30 and where the test showed compliance of the fertiliser in question.
2. Member States shall ensure that sampling and analysis for official controls of EC fertilisers belonging to types of fertilisers listed in Annex I are carried out in accordance with the methods described in Annex III and IV.
3. Compliance with this Regulation in respect of conformity to types of fertiliser and compliance with the declared nutrient content and/or the declared content expressed as forms and solubilities of such nutrients may be verified at official inspections only by means of sampling and analysis methods established in accordance with Annex III and IV and taking into account the tolerances specified in Annex II.
4. The adaptation and modernisation of measuring, sampling and analysis methods shall follow the procedure referred to in Article 32(2), and shall, wherever possible, use European Standards. The same procedure shall apply to the adoption of implementing rules needed to specify the control measures provided for in this Article and in Articles 8, 26 and 27 of this Regulation. Such rules shall in particular address the question of the frequency with which tests need to be repeated, as well as measures that are designed to ensure that the fertiliser put on the market is identical with the fertiliser tested.
Article 30 - Laboratories
2. The Commission shall publish the list of approved laboratories in the Official Journal of the European Union.
3. Where a Member State has justifiable grounds for believing that an approved laboratory does not meet the standards referred to in paragraph 1, it shall raise this matter in the committee referred to in Article 32. If the committee agrees that the laboratory does not meet the standards, the Commission shall remove the name from the list referred to in paragraph 2.
4. The Commission shall adopt a decision on the matter within 90 days from the receipt of the information in accordance with the procedure referred to in Article 32(2).
5. The Commission shall publish the amended list in the Official Journal of the European Union.
TITLE IV - FINAL PROVISIONS
CHAPTER I - Adaptation of the Annexes
Article 31 - New EC fertilisers
2. A manufacturer or its representative which wishes to propose a new type of fertiliser for inclusion in Annex I and is required to compile a technical file for that purpose shall do so by taking into account the technical documents referred to in section A of Annex V.
3. Amendments required to adapt the Annexes to technical progress shall be adopted in accordance with the procedure referred to in Article 32(2).
Article 32 - Committee procedure
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The committee shall adopt its rules of procedure.
CHAPTER II - Transitional provisions
Article 33 - Competent laboratories
2. Member States shall notify the list of these laboratories to the Commission, giving details of their authorisation scheme. Such notification shall be made by 11 June 2004 and on the occasion of each subsequent modification.
Article 34 - Packaging and labelling
CHAPTER III - Final provisions
Article 35 - Repealed Directives
2. References to the Directives repealed shall be construed as references to this Regulation. In particular, derogations from Article 7 of Directive 76/116/EEC that were granted by the Commission under Article 95(6) of the Treaty shall be construed as derogations from Article 5 of the present Regulation and shall continue to produce their effects notwithstanding the entry into force of this Regulation. Pending the adoption of penalties under Article 36, Member States may continue to apply penalties for infringements of national rules implementing the Directives mentioned in paragraph 1.
Article 36 - Penalties
Article 37 - National provisions
Article 38 - Entry into force
This Regulation shall be binding in its entirety and directly applicable in all Member States.