Commission Regulation (EU) 2016/1618
of 8 September 2016
amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers, and in particular paragraphs 1 and 3 of Article 31 and Article 29(4) thereof,
OJ L 304, 21.11.2003, p. 1.
Whereas:
(1) Requests have been submitted pursuant to Article 31(2) of Regulation (EC) No 2003/2003 for inclusion in Annex I to that Regulation of a number of fertilisers.
(2) [S,S]-Ethylenediaminedisuccinic acid (hereinafter ‘[S,S]-EDDS’) is an organic chelating agent for micro-nutrients. Iron chelated with [S,S]-EDDS is used to correct iron shortages and to remedy ferric chlorosis for ornamental crops and decorative lawn turfs. It degrades rapidly thus posing minimal leaching concerns from top soils to groundwater and is completely mineralised, exhibiting no mammalian and aquatic toxicity.
(3) Heptagluconic acid (hereinafter ‘HGA’) is an organic complexing agent for micro-nutrient fertilisers. HGA is effective, biodegradable, showing good stability over a wide range of pH values and high solubility in water. HGA has been authorised for many years in Spain without any reported damage to the environment, nor to human health.
(4) Manufacturers of [S,S]-EDDS and HGA have submitted requests to the Commission, via the authorities of Germany and Spain, to include those substances in the list of authorised organic chelating and complexing agents in Annex I to Regulation (EC) No 2003/2003 in order to make [S,S]-EDDS and HGA available to farmers throughout the Union. [S,S]-EDDS and HGA, as specified in Annex I to this Regulation, fulfil the requirements stipulated in Article 14 of Regulation (EC) No 2003/2003. They should therefore be added to the list of authorised organic chelating and complexing agents in Annex I to that Regulation.
(5) Since analytical methods for determination of [S,S]-EDDS and HGA are available, those methods should be specified in Annex IV to Regulation (EC) No 2003/2003, for the purpose of facilitating the controls that Member States exercise pursuant to Article 29 of that Regulation. The subtitle describing Methods 11 should reflect the fact that HGA is a complexing agent.
(6) The reaction mixture between N-butylphosphorothioic triamide and N-propylphosphorothioic triamide was introduced in Annex I to Regulation (EC) No 2003/2003 by Commission Regulation (EU) No 1257/2014. Recent research has shown that no significant difference in the reduction of ammonia emissions from the use of either the reaction mixture or the mere mixture of the two substances can be expected. Therefore the entry should be amended in order to allow the producers of such mixture to opt for one of these production routes.
Commission Regulation (EU) No 1257/2014 of 24 November 2014 amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV (OJ L 337, 25.11.2014, p. 53).
(7) Regulation (EC) No 2003/2003 should therefore be amended accordingly.
(8) In order to ensure that the analytical method for [S,S]-EDDS, which is currently under validation, is published by the European Committee for Standardisation, a reasonable period of time should be provided for before the inclusion of [S,S]-EDDS in Annex I to Regulation (EC) No 2003/2003 and the new analytical method for this fertiliser type in its Annex IV applies.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 32 of Regulation (EC) No 2003/2003,
HAS ADOPTED THIS REGULATION:

Article 1 Amendments
Regulation (EC) No 2003/2003 is amended as follows:
(1) Annex I is amended in accordance with Annex I to this Regulation;
(2) Annex IV is amended in accordance with Annex II to this Regulation.

Article 2 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
However, Annex I, point (1) and Annex II, point (2) shall apply from 1 July 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 September 2016.
For the Commission
The President
Jean-Claude Juncker
ANNEX I Annex I to Regulation (EC) No 2003/2003 is amended as follows:
(1) in the table in Section E.3.1, the following entry is added:

‘12	[S,S]-Ethylenediaminedisuccinic acid	[S,S]-EDDS	C10H16O8N2	20846-91-7’

(2) in the table in Section E.3.2, the following entry is added:

‘2	Heptagluconic acid	HGA	C7H14O8	23351-51-1’

(3) in the table in Section F.2, entry 3 is replaced by the following:

‘3	Mixture of N-butylphosphorothioic triamide (NBPT) and N-propylphosphorothioic triamide (NPPT) (ratio 3:1 Tolerance on the portion of NPPT: 20 %.’ ) Reaction mixture: EC No 700-457-2 Mixture of NBPT/NPPT: NBPT: ELINCS No 435-740-7 NPPT: CAS No 916809-14-8	Minimum: 0,02 Maximum: 0,3		

ANNEX II Annex IV to Regulation (EC) No 2003/2003 is amended as follows:
(1) in Section B, under the heading ‘Methods 11’, the subtitle ‘Chelating agents’ is replaced by ‘Chelating and complexing agents’;
(2) in Section B, the following Method 11.9 is added:

‘Determination of [S,S]-EDDS
EN 13368-3 Part 3: Fertilizers — Determination of chelating agents in fertilizers by chromatography: Determination of [S,S]-EDDS by ion pair chromatography
This method of analysis has been ring-tested.’;

(3) in Section B, the following Method 11.10 is added:

‘Determination of HGA
EN 16847: Fertilizers — Determination of complexing agents in fertilizers — Identification of heptagluconic acid by chromatography
This method of analysis has been ring-tested.’