(fra kommisjonsforordningen)

(1) Calcium cyanamide is used, inter alia, as a slow-release nitrogen fertiliser. The fertiliser is supplied in the EU in granular form, mainly to professional farmers, in one registrant’s commercial formulation called PERLKA®’. It is typically applied as a fertiliser in three different ways depending upon the crop: surface application onto a soil surface, uniform incorporation from the soil surface down to a specific depth or deep placement via a tube. In moist soils, calcium cyanamide is transformed into cyanamide and calcium hydroxide. Cyanamide is further transformed into urea and cyanoguanidine. Cyanamide, urea and cyanoguanidine (‘transformation substances’) are transported to the aquatic compartment via run-off from the surface of fertilised fields adjacent to surface waters or via drainage through soil. Cyanamide is classified as Aquatic Chronic 3 (H412: Harmful to aquatic life with long lasting effects) in Part 3 of Annex VI to Regulation (EC) No 1272/20082 . The single registrant for calcium cyanamide under REACH (‘the registrant’), self-classifies calcium cyanamide in the same hazard class. Urea and cyanoguanidine are also hazardous to aquatic or soil organisms. 

(2) On 22 March 2016, the Scientific Committee on Health and Environmental Risks (SCHER) concluded that harmful effects for humans and the environment could not be excluded when calcium cyanamide is used as a fertiliser. The Commission, therefore, requested the European Chemicals Agency (‘the Agency’) to carry out a preliminary assessment of the risks posed by calcium cyanamide used as a fertiliser to human health and the environment. In January 2018, the Agency concluded that SCHER’s assessment may have underestimated the risk that calcium cyanamide used as a fertiliser poses to the environment. The Agency’s concern was that a risk to aquatic organisms may be present in a greater number of aquatic exposure scenarios than previously identified; there were also uncertainties associated with the possible risk of calcium cyanamide to a wide range of terrestrial organisms. Based on an advance copy of these findings indicating the presence of a risk to the environment, on 24 November 2017 the Commission requested the Agency to prepare a dossier, pursuant to Article 69(1) of Regulation (EC) No 1907/2006 (‘Annex XV dossier’), with a view to a possible restriction of calcium cyanamide as a fertiliser. 

(3) On 19 July 2019, the Agency submitted the Annex XV dossier on the use of calcium cyanamide as a fertiliser. The Agency found that the use of calcium cyanamide as a fertiliser (using application rates and methods as recommended by the registrant) leads to a risk of toxicity to aquatic and soil organisms that is not adequately controlled both for surface waters adjacent to fertilised fields and for soil. The risk is mainly due to the toxicity of cyanamide to aquatic and soil macroorganisms. In some scenarios, and to a lesser degree, the risk is also due to the toxicity of urea to algae and to the toxicity of cyanoguanidine to soil microorganisms. The Agency proposed a restriction on the placing on the market of calcium cyanamide for use as a fertiliser with a transitional period of 36 months. 

(4) On 11 June 2020, the Agency’s Committee for Risk Assessment (‘RAC’) adopted its opinion8 concluding that the proposed restriction on the use and placing on the market of calcium cyanamide as a fertiliser is the most appropriate Union-wide measure to address the identified risk in terms of its effectiveness in reducing the risk, its practicality and its monitorability. RAC noted that the powder form of calcium cyanamide fertiliser was voluntarily removed from the market by the registrant in January 2018. Since then, only the granular form has been placed on the market. RAC proposed a shorter transitional period of 24 months for a restriction on the placing of calcium cyanamide on the market as a fertiliser, to reduce the potential for stockpiling by end users that could result in its use as a fertiliser beyond the proposed transitional period of 36 months for use. 

(5) RAC agreed with the Agency and the registrant that the ecotoxicological data from the studies using cyanamide as the test substance can be used in a read-across approach for the environmental assessment of calcium cyanamide. RAC agreed with the Agency on the environmental hazard assessment and the Predicted No-Effect Concentration (‘PNEC’) values of calcium cyanamide (based on read-across from cyanamide) and of cyanoguanidine in freshwater and sediment. However, RAC disagreed with the Agency on the PNEC value of urea in freshwater, which was considered not to be sufficiently reliable for hazard assessment. RAC concurred with the conclusion of the Agency on the hazard assessment for the terrestrial (soil) environment for calcium cyanamide (based on read-across from cyanamide), as well as for urea and cyanaguanidine. However, PNEC values for urea in soil were not reported by the Agency, as conclusive data was not available, and RAC supported the argument that urea is of inherently low toxicity. 

(6) The exposure assessment relied on modelling, as there was no conclusive environmental monitoring data available. RAC considered the predicted environmental concentration (‘PEC’) values of calcium cyanamide and its transformation substances obtained by the Agency for surface water and sediment applying FOCUS exposure modelling, taking into account the different application methods. RAC also considered the PEC values for the terrestrial environment applying the typical modelling approach for substances intentionally added to soil that are commonly used as plant protection products. RAC concluded that both values were reliable. FOCUS PEARL modelling was used by both the Agency and the registrant, to predict PEC values of calcium cyanamide and its transformation substances in groundwater, which was also considered to be reliable by RAC. 

(7) RAC agreed with the Agency that the use of calcium cyanamide as a fertiliser (using application rates and methods recommended by the registrant) leads to a risk that is not adequately controlled, both for surface water adjacent to fertilised fields and for soil, since the relevant risk characterisation ratio values were greater than one. The risk is primarily due to the effects of cyanamide but also, in some scenarios, to those of cyanoguanidine and urea. 

(8) The Agency assessed four restriction options to address the identified risks against the criteria of effectiveness, practicality and monitorability. The Agency found that two of those restriction options, a prohibition of the powder form of calcium cyanamide and a requirement to follow the rules of existing Common Agricultural Policy measures of cross-compliance, would not address the identified risks. RAC noted that, of the other two restriction options examined in the Annex XV dossier, the restriction option of using mandatory vegetated buffer strips was insufficient to reduce the risk to adjacent surface water and the risk to the terrestrial compartment from the use of calcium cyanamide as a fertiliser would not be addressed. As a result, RAC agreed with the Agency that only the option of a restriction on placing on the market and use of calcium cyanamide as a fertiliser, as a substance on its own or in a mixture, can fully address the identified risk and also be effective in reducing that risk, both from a practical and monitoring perspective. 

(9) On 17 September 2020, the Agency’s Committee for Socio-economic Analysis (‘SEAC’) adopted its opinion. SEAC noted that the Agency highlighted that, in addition to its function as slow-release fertiliser, calcium cyanamide has secondary effects such as herbicidal, fungicidal, molluscicidal effects as well as other effects that aid plant growth, which were recognised to be potentially useful for farmers. SEAC also noted that calcium cyanamide is not approved as an active substance for use in plant protection products under Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

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