Commission Decision

of 24 May 2002

on the national provisions notified by the Kingdom of Sweden under Article 95(4) of the EC Treaty concerning the maximum admissible content of cadmium in fertilisers

(notified under document number C(2002) 1932)

(Only the Swedish text is authentic)

(Text with EEA relevance)

(2002/399/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, in particular Article 95(6) thereof,

Whereas:

I. FACTS

1. COMMUNITY LEGISLATION

(1) Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilisers(1), as last amended by Directive 98/97/EC(2), lays down the requirements that fertilisers must fulfil in order to be placed on the market with the designation "EC fertilisers"(3).

(2) Annex I of the Directive 76/116/EEC sets out the type designation and the corresponding requirements, e.g. with respect to its composition, that each EC-designated fertiliser must fulfil. EC-designated fertilisers included in this list are grouped into categories, depending on the content of the primary nutrients, i.e. the elements nitrogen, phosphorus and potassium.

(3) Directive 76/116/EEC has been amended and adapted to technical progress several times in order, inter alia, to include new fertiliser-types in Annex I.

(4) The amendments to Directive 76/116/EEC have been introduced by the following Directives:

- Directive 88/183/EEC(4) has extended the scope of Directive 76/116/EEC to include in Annex I straight and compound fluids fertilisers,

- Directive 89/284/EEC(5) has extended the scope of Directive 76/116/EEC to include in Annex I fertilisers containing calcium, magnesium, sodium and sulphur,

- Directive 89/530/EEC(6) has extended the scope of Directive 76/116/EEC to include in Annex I solid or liquid fertilisers containing:

- one of the following trace elements: boron, cobalt, copper, iron, manganese, molybdenum and zinc,

- mixtures of such fertilisers containing at least two of these trace elements,

- a list of authorised organic chelating agents for trace elements.

(5) The adaptations to technical progress to Directive 76/116/EEC have been introduced by Directive 93/69/EEC(7), Directive 96/28/EC(8) and Directive 98/3/EC(9). Under these Directives, new fertilisers are added to the Annexes of Directive 76/116/EEC.

(6) For the purposes of this Decision, the term Directive 76/116/EEC shall be construed as referring to that Directive as amended by the Directives mentioned in recitals 4 and 5 above.

(7) The rules governing the composition of fertilisers covered by Directive 76/116/EEC do not provide for a limit value for the cadmium content of EC-designated fertilisers.

(8) According to Article 7 of Directive 76/116/EEC, Member States may not on grounds of composition, identification, labelling or packaging, prohibit, restrict or hinder the marketing of fertilisers marked "EC fertiliser" which comply with the provisions of this Directive and the Annexes thereto.

2. THE ACCESSION OF SWEDEN

(9) Sweden acceded to the European Union on 1 January 1995. The Act of Accession(10) lays down transitional provisions concerning the use and marketing of cadmium in that State. Article 112(1) provides that during a period of four years from the date of accession, the provisions referred to in Annex XII of the Act shall, in accordance with that Annex and subject to the conditions set out therein, not apply to Sweden. Article 112 and point 4 of Annex XII of the Act of Accession provide that Article 7 of Directive 76/116/EEC, in so far as it concerns the cadmium content of fertilisers, shall not apply to Sweden before 1 January 1999 and that the provisions of Directive 76/116/EEC will be reviewed in accordance with Community procedures by 31 December 1998.

(10) Article 2 of the Act of Accession provides that "from the date of accession, the provisions of the original Treaties and the acts adopted by the institutions before accession shall be binding on the new Member States and shall apply in those States under the conditions laid down in those Treaties and in this Act". Article 168 of the Act of Accession stipulates that "the new Member States shall put into effect the measures necessary for them to comply, from the date of accession, with the provisions of directives and decisions within the meaning of Article 189 (now Article 249) of the EC Treaty [...], unless a time limit is provided for in the list of Annex XIX or in any other provisions of this Act".

(11) Directive 98/97/EC of the European Parliament and of the Council(11) subsequently amended Directive 76/116/EEC as regards the marketing in Austria, Finland and Sweden of fertilisers containing cadmium. Article 1 provides that, inter alia, Sweden may prohibit the marketing on its territory of fertilisers containing cadmium at concentrations in excess of that which was fixed nationally at the date of accession and that this derogation applies for the period from 1 January 1999 until 31 December 2001.

3. NATIONAL PROVISIONS

(12) "The Chemicals Products (Handling, Import and Export Prohibitions) Ordinance" (1998:944)(12) contains provisions relating, inter alia, to the maximum permissible cadmium content in fertilisers, including EC-designated fertilisers. Section 3, paragraph 3, of the Ordinance, provides that fertilisers covered by customs tariffs numbers 25.10, 28.09, 28.35, 31.03 and 31.05 containing in excess of 100 grams of cadmium per tonne of phosphorous may not be offered for sale or transferred.

(13) The provisions relating to the maximum permissible cadmium content in fertilisers have been in force since 1985 following the adoption of "The Cadmium Ordinance" (1985:839). "The Chemicals Products Ordinance" (1998:944) codifies different provisions relating to the protection of the environment, including those contained in "The Cadmium Ordinance" (1985:839).

II. PROCEDURE

(14) By letter of 7 December 2001, the Swedish authorities notified the Commission that Sweden, in accordance with article 95(4) of the EC Treaty, intends to continue to apply from 1 January 2002 national provisions concerning the cadmium content in fertilisers.

(15) By letter of 8 January 2002, the Commission informed the Swedish authorities that it had received the notification under Article 95(4) and that the six months period for its examination according to Article 95(6) started on 8 December 2001, the day following the one when the notification was received.

(16) By letter of 23 January 2002, the Commission informed the other Member States about the request received from Sweden. The Commission also published a notice regarding the request in the Official Journal of the European Communities(13) in order to inform other interested parties of the national measures that Sweden intends to maintain.

III. ASSESSMENT

1. CONSIDERATION OF ADMISSIBILITY

(17) Article 95(4) of the Treaty provides that, if, after the adoption by the Council or by the Commission of a harmonisation measure, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 30, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.

(18) The notification submitted by the Swedish authorities on 7 December 2001 intends to obtain authorisation to maintain national provisions incompatible with those concerning the composition of EC-denominated fertilisers contained in Directive 76/116/EEC.

(19) As already indicated, Article 7 of Directive 76/116/EEC prevents Member States from restricting the marketing of EC-denominated fertilisers because of their composition, but the rules governing composition do not set any limit value for cadmium content. This means that pursuant to Article 7 of Directive 76/116/EEC, EC-denominated fertilisers complying with the requirements of that Directive can be placed on the market regardless of their cadmium content.

(20) In the light of the abovementioned, it is clear that the national provisions notified by Sweden, in so far as they prohibit the placing on the market of phosphorus-based EC-denominated fertilisers with a cadmium content exceeding 100 grams per tonne of phosphorus, are more restrictive than those contained in Directive 76/116/EEC.

(21) The national provisions notified by the Swedish authorities were adopted in 1985, therefore before Sweden acceded to the European Union. As indicated above, the Act of Accession lays down transitional provisions allowing Sweden to continue to apply its national provisions concerning the cadmium content of fertilisers to products covered by Directive 76/116/EEC for a period of four years. By Directive 98/97/EC, Sweden was authorised to continue to apply the above national provisions until 31 December 2001.

(22) As required by Article 95(4), as interpreted in the light of Articles 2 and 168 of the Act of Accession, Sweden notified the Commission of the actual wording of the provisions adopted before the accession to the European Union that it intends to maintain, accompanying the request by an explanation of the reasons which, in its opinion, justify the maintenance of those provisions.

(23) The notification submitted by Sweden on 7 December 2001 in order to obtain approval for maintaining national provisions derogating from the provisions of Directive 76/116/EEC, is therefore to be considered admissible under Article 95(4) as interpreted in the light of Articles 2 and 168 of the Act of Accession.

2. ASSESSMENT OF MERITS

(24) In accordance with Article 95 of the Treaty, the Commission has to ensure that all the conditions enabling a Member State to avail itself of the possibilities of derogation provided for in this article are fulfilled.

(25) In particular, the Commission has to assess whether the provisions notified by the Member State are justified on grounds of major needs referred to in Article 30 of the Treaty, or relating to the protection of the environment or the working environment.

(26) In addition, pursuant to Article 95(6) of the Treaty, where it considers that the national provisions are justified, the Commission must check whether or not those national provisions are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they constitute an obstacle to the functioning of the internal market.

(27) Sweden has based its request on the need of protection of human health and the environment. Cadmium in fertilisers is deemed to pose a threat to the environment and human health. In support of its request, Sweden makes reference to the conclusions of a Swedish study published on 4 October 2000(14), which contains an assessment of the environmental risks posed by cadmium-containing fertilisers.

2.1. JUSTIFICATION ON GROUNDS OF MAJOR NEEDS

2.1.1. General information on cadmium

(28) Cadmium is a heavy metal naturally present in the environment, but most emissions of this metal are due to various human activities (production of non-ferrous metals, incineration of fossil fuels, application of fertiliser, etc.).

(29) A general risk assessment on cadmium metal and cadmium oxide is currently being carried out under Council Regulation 793/93/EEC of 23 March 1993 on the evaluation and control of the risks of existing substances(15) with Belgium acting as rapporteur. This risk assessment will address all important uses and emissions of cadmium. At present only an incomplete draft report is available for discussions at the technical level.

(30) From the scientific data available up to now, it can be concluded that cadmium metal and cadmium oxide in general can be considered to pose serious risks to health. In particular, cadmium oxide has been classified as a carcinogen, mutagen or substance toxic for reproduction, category 2(16). It is also generally agreed that cadmium in fertilisers is by far the most important source of cadmium input to soil and to the food chain.

2.1.2. Cadmium in fertilisers

(31) Cadmium is present in the natural state in the phosphate mineral rocks which are mined for use as raw material to manufacture phosphatic mineral fertilisers. In the finished state, these fertilisers always contain certain amounts of cadmium, depending on the original content of the phosphate rocks.

(32) Cadmium is regarded as harmful both to the environment and to human health. Phosphate fertilisers have been identified as a major source of cadmium on arable land, where it tends to accumulate over time. Crops tend to absorb cadmium from the soil, and the cadmium content of food, which is the main source of human intake of cadmium, has become an issue of concern for human health. When ingested in food, cadmium tends to accumulate in the kidneys and may eventually lead to kidney dysfunction in vulnerable groups.

(33) The environmental concerns raised by cadmium in fertilisers were first raised at Community level during the negotiations for the Accession of Austria, Finland and Sweden to the European Union. As indicated above, those three Member States were granted temporary derogations from Community legislation on fertilisers in order to allow a careful evaluation of the risks from cadmium in fertilisers at Community level.

(34) In this context, the Commission first gathered all available data and information on the exposure situation in the European Community from cadmium in fertilisers. As not enough data were available in all Member States, the Commission mandated two studies to elaborate a methodology and procedures with a view to assessing the risks to health and the environment from cadmium in fertilisers(17). Member States were subsequently invited to carry out nation-wide risk assessments by making use of the above methodology and procedures.

(35) Nine Member States have completed risk assessments concerning cadmium in fertilisers. These risk assessments have been made available to the public since September 2001 on the Commission's web-site(18). In addition, a separate study which analyses these risk assessments has been published and various options for risk management of cadmium in fertilisers at a Community wide scale have been developed(19).

(36) The above risk assessments have also been submitted to the SCTEE (Scientific Committee for Toxicity, Ecotoxicity and the Environment) and are currently under evaluation. In particular, the SCTEE has been asked to indicate what is the highest cadmium concentration in fertilisers that can be tolerated in order to avoid a significant increase in the cadmium content of cultivated soil due to the application of phosphate fertilisers.

(37) The completion of the risk assessments took a relatively long time. Moreover, the SCTEE needs time in order to assess the scientific material thoroughly. It was therefore not possible to present a proposal for a Regulation on cadmium limits in fertilisers by 31 December 2001.

2.1.3. The risk assessment carried out by Sweden

(38) The risk assessment submitted by the Swedish authorities is part of the above process of information-gathering based on common methodology and procedures. The framework used by Sweden for conducting its risk assessment is built around three modules:

2.1.3.1. The accumulation module

(39) According to this module, the net accumulation of cadmium in soil and soil solution (or pore water)(20), resulting from the application of fertiliser, is computed over time and at steady state. The accumulation module allows for a range of inputs, for example average and extreme rates of application. The Swedish risk assessment shows that with this module, the following parameters have been considered:

- the present day cadmium concentration,

- the input of cadmium to agricultural soil through atmospheric deposition, manure and fertiliser applications,

- the cadmium offtake rate by plants,

- the cadmium leaching rate from the plough layer depending on the cadmium concentration in the soil pore water and the water flux,

- the concentration of cadmium in the soil and leaching rates at zero and one hundred years.

2.1.3.2. The exposure module

(40) According to this module, the uptake of cadmium from soil into cultivated plants and the subsequent intake of cadmium by humans are computed, using exposure parameters characterising both average and extreme exposure scenarios. Environmental exposure is also characterised for vulnerable environments and is taken to be the predicted cadmium concentration in a particular environmental compartment.

2.1.3.3. The risk characterisation module

(41) This module allows Sweden to estimate the incidence and severity of the adverse effects likely to occur due to actual or predicted exposure to cadmium.

2.1.4. The results of the risk assessment

(42) The application of the modules has produced the following results:

- concerning surface water, the Swedish risk assessment report states that "the chosen PNEC(21) value implies that in most rivers in southern Sweden, certain biota would already be affected by cadmium i.e. risk characterisation ratios(22) are larger than one(23). If higher cadmium content in fertilisers would be allowed, a further increase in the exposure of and the concern for effects in the aquatic environment is expected to occur",

- concerning the soil, the Swedish risk assessment report states that "by using the Swedish fertiliser for one hundred years on common Swedish soils (PNEC 0,25 mg/kg), no concern for ecological effects is predicted when potatoes or wheat are grown. A concern is predicted when carrots are grown, but this concern is also present at time zero. With the EC fertiliser, a concern is predicted in all cases. In acid, sandy soils that are poor in clay and organic matter (PNEC 0,06 mg/kg), a risk is predicted even if the cadmium content in fertilisers is zero".

(43) It is clear that these conclusions refer to the specific situation of the Swedish soil as well as the climatic conditions prevailing in Sweden.

(44) In conclusion, the risk assessment carried out by Sweden shows that if fertilisers with a higher cadmium content than currently permitted would be allowed, this would lead to:

- a substantial increase in the cadmium concentrations of soils, which in turn would lead to toxic effects on soil organisms. Unacceptable concentrations could also appear in watercourses in agricultural regions,

- a substantial increase in the dietary intake of cadmium. The safety margin between current exposure and the World Health Organisation Provisional Tolerable Weekly Intake level is extremely small. For some high-risk groups, such as women with low body iron stores, there are no safety margins at all. A high dietary intake of cadmium could therefore lead to a larger number of people becoming subject to reduced kidney function and increased osteoporosis.

2.1.5. Evaluation of the position of Sweden

(45) The risk assessment submitted by the Swedish authorities has been carried out according to the procedures and the methodology established at Community level, which are considered to ensure a high degree of reliability of the information obtained.

(46) The Commission already examined the information contained in this risk assessment in the context of the preparatory work of the proposal for a new Regulation relating to fertilisers(24). At that time, the Commission considered that the information available provided sufficient indication of a risk for the environment and human health arising from the application to the Swedish soil of cadmium-containing fertilisers. The Commission therefore proposed in Article 33 of its proposal an extension of the derogation already granted to Austria, Finland and Sweden in the Accession Treaty. As the proposed Regulation could not be adopted in time, Sweden has applied for an individual Decision under Article 95(6).

(47) After having re-examined the scientific evidence in the light of the Swedish request, the Commission considers that the Swedish authorities have shown that cadmium-containing fertilisers pose environmental and human health risks, and that the national provisions notified by the Swedish authorities aiming to limit to the minimum the exposure of the Swedish environment to cadmium-containing fertilisers are justified.

2.2. ABSENCE OF ARBITRARY DISCRIMINATION

(48) Article 95(6) obliges the Commission to verify that the envisaged measures are not a means of arbitrary discrimination. According to the ruling of the Court of Justice, the absence of discrimination means that national restrictions on trade cannot be used in such a way as to create discrimination in respect of goods originating in other Member States.

(49) The envisaged national provisions are general and apply to national and imported phosphorous-based EC-designated fertilisers alike. As a result, there is no evidence that they can be used as a means of arbitrary discrimination between economic operators in the Community.

2.3. ABSENCE OF A DISGUISED RESTRICTION ON TRADE

(50) More restrictive national measures governing the composition of EC-designated fertilisers that derogate from the provisions of a Community Directive normally constitute a barrier to trade. Products that can be legally placed on the market in the rest of the Community cannot be placed on the market in the Member State concerned. The concept enshrined in paragraph 6 of Article 95 is intended to prevent the national provisions based on the criteria set out in paragraphs 4 and 5 being applied for inappropriate reasons, and in reality constituting economic measures to be introduced to impede the import of products from other Member States in order to indirectly protect national production.

(51) As already established, there is concern with regard to the protection of the environment and human health due to the application on soil of cadmium-containing fertilisers. Therefore, the protection of the environment and human health appears to be the goal of maintaining the national provisions and not the creation of disguised barriers to trade.

2.4. ABSENCE OF OBSTACLES TO THE FUNCTIONING OF THE INTERNAL MARKET

(52) This condition cannot be interpreted in such a way that it prohibits the approval of any national measure likely to affect the establishment of the Internal Market. In fact, any national measure derogating from a harmonisation measure aiming at the establishment and operation of the Internal Market, constitutes in substance a measure that is likely to affect the Internal Market. Consequently, to preserve the useful character of the procedure for derogation provided for by Article 95 of the EC Treaty, the Commission considers that, in the context of Article 95(6), the concept of obstacle to the functioning of the Internal Market has to be understood as a disproportionate effect in relation to the pursued objective.

(53) In view of the risks for both the environment and human health resulting from the application of cadmium-containing fertilisers to the Swedish soil and taking into account that:

- as indicated above, the Act of Accession and Directive 98/97/EC allowed Sweden to continue to apply its national provisions concerning the cadmium content in fertilisers awaiting the completion of the review of Directive 76/116/EEC as regards the issue of the cadmium content in fertilisers, and

- the opinion of the SCTEE was not available in time to be considered for this Decision in order to provide a sufficient scientific basis for the Commission to propose an approximation of Community limit values for the cadmium content in fertilisers, or to determine whether there would be a less restrictive measure,

the Commission considers that, at this stage of the review, there is no evidence indicating that the national provisions do constitute a disproportionate obstacle to the functioning of the internal market in relation to the pursued objectives.

2.5. LIMITATION IN TIME

(54) Sweden asked the Commission to take a decision under Article 95(6) of the Treaty before 31 December 2001. Should the Commission approve the request for a derogation, Sweden asked that the Decision shall take effect from 1 January 2002.

(55) It should first be noted that given the procedural framework established in Article 95 of the Treaty and in particular the six-month deadline for a Decision to be adopted, it is incumbent on Member States to submit a notification to the Commission in time so that the Commission is able to adopt a decision on the notification before the relevant Community harmonisation measure becomes enforceable(25).

(56) It should be recalled that the principle of legal certainty, which is a general principle of Community law, excludes, for the most part, retroactive application of Community legislation, except where the objective to be achieved requires it and then only on condition that the legitimate expectations of the parties concerned are respected(26).

(57) In the light of the foregoing, the Commission does not consider that in the present case the conditions exist for giving a retroactive effect to the Decision approving the national provisions. In fact, although there is a need to protect human health and the environment from the risks posed by cadmium in fertilisers, to render the more stringent national measures applicable retroactively would, in effect, be tantamount to undermining the legitimate expectations of those economic operators who acted in the belief that the rules in force after 31 December 2001 were the more liberal ones deriving from Directive 76/116/EEC.

(58) The period for which the derogation is granted should allow sufficient time for the Commission to propose and for the Council and the European Parliament to adopt a Legislation concerning cadmium in fertilisers at Community level. It is estimated that such a Legislation could enter into force in 2005. The derogation of Sweden should therefore expire on 31 December 2005.

IV. CONCLUSION

(59) In the light of the foregoing, it can be concluded that the request by Sweden for maintaining national provisions that are more restrictive than the provisions of Directive 76/116/EEC with regard to the cadmium content of fertilisers, as submitted on 7 December 2001, is admissible.

Moreover, the Commission finds that the national provisions:

- meet needs on grounds of the protection of human health and the environment;

- are proportionate to the objectives pursued;

- do not constitute a means of arbitrary discrimination and

- do not constitute a disguised restriction on trade between Member States.

The Commission therefore considers that they can be approved,

HAS ADOPTED THIS DECISION:

Article 1

In derogation from Directive 76/116/EEC, the Swedish provisions which prohibit the placing on the Swedish market of fertilisers containing in excess of 100 grams of cadmium per tonne of phosphorous are approved.

The derogation shall apply until 31 December 2005.

Article 2

This Decision is addressed to the Kingdom of Sweden.

Done at Brussels, 24 May 2002.

For the Commission

Erkki Liikanen

Member of the Commission

(1) OJ L 24, 30.1.1976, p. 21.

(2) OJ L 18, 23.1.1999, p. 60.

(3) The term "EEC fertilizer" provided for by Directive 76/116/EEC was replaced by the term "EC fertiliser" by Directive 97/63/EC (OJ L 335, 6.12.1997, p. 15)

(4) OJ L 83, 29.3.1988, p. 33.

(5) OJ L 111, 22.4.1989, p. 34.

(6) OJ L 281, 30.9.1989, p. 116.

(7) OJ L 185, 28.7.1993, p. 30.

(8) OJ L 140, 13.6.1996, p. 30.

(9) OJ L 18, 23.1.1998, p. 25.

(10) OJ C 241, 29.8.1994, p. 41 and p. 316.

(11) OJ L 18, 23.1.1999, p. 60.

(12) Swedish Code of Statutes (SFS Svensk Författningssamling) of 14 July 1998.

(13) OJ C 23, 25.1.2002, p. 6.

(14) Swedish National Chemical Inspectorate, Assessment of risks to health and the environment in Sweden from cadmium in fertilisers, 4 October 2000.

(15) OJ L 84, 5.4.1993, p. 1.

(16) See Annex I to Directive 67/548/EEC and Annex I to Directive 76/769/EEC as amended.

(17) ERM, Study on data requirements and programme for data production and gathering to support a future evaluation of the risks to health and the environment from cadmium in fertilisers, March 1999, and A study to establish a programme of detailed procedures for the assessment of risks to health and the environment from cadmium in fertilisers, February 2000. (ERM (Environmental Resources Management) is the consultant who developed the methodology for the risk assessments).

(18) http://europa.eu.int/comm/enterprise/chemicals/fertilizers/riskassest/reports.htm

(19) ERM, Analysis and conclusions from Member States' assessment of the risk to health and the environment from cadmium in fertilisers, October 2001.

(20) Pore water means that part of the water contained in the soil which is maintained by capillarity between the solid particles of the soil.

(21) PNEC: predicted no effect concentration.

(22) These ratios are PEC/PNEC where PEC is the predicted environmental concentration.

(23) A PEC/PNEC ratio greater than 1 indicates that there will be adverse effects.

(24) Commission proposal for a European Parliament and Council Regulation relating to fertilisers - COM(2001) 508 final of 14.9.2001.

(25) In this connection, it is pointed out that the European Court of Justice, in paragraph 35 of its judgement of 1 June 1999 delivered in case C-319/97, states that "it is incumbent on Member States under Article 10 EC (ex Article 5) to notify as soon as possible the provisions of national law which are incompatible with a harmonisation measure and which they intend to maintain in force".

(26) European Court of Justice's judgement of 25 January 1979 delivered in case C-98/78 Racke [1979] ECR 69, paragraph 20. See also the judgements delivered in the following cases: C-110/97 the Netherlands v Council, [2001] ECR 000, paragraph 151; C-99/78 Decker [1979] ECR 101, paragraph 8; C-258/80 Rummy v Commission [1982] ECR 487, paragraph 11; and C-337/88 SAFA [1990] ECR I-1, paragraph 13.