Working Document: Does Not Necessarily Represent the Views of the Commission

WORKING DOCUMENT: DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION

EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate B - Protecting the Natural Environment ENV.B.3 – Biotechnology, Pesticides and Health

Brussels, ENV B.3

Preliminary conclusions on the request for derogation for essential use of Ammonia submitted by France

Background

The competent authorities of France submitted on 29 May 2006, in accordance with article 4a of Commission Regulation (EC) N° 2032/2003, an application for granting an extension of the period laid down in Article 4(2) of that Regulation for placing the substance ammonia anhydrous (EC nr 231-635-3, CAS nr 7664-41-7) on their market for product type 3 - on the grounds that its use is essential.

The application was published on 29 May 2006 on the Commission website1 and opened for comments by Member States and stakeholders for a period of 60 days. Comments were received from the UK (14.06.06) and Austrian (31.07.06) competent authorities, and the companies Lanxess (28.07.06) and Menno Chemie (28.07.06).

Main arguments presented in the application

The competent authorities (CA) of France explained in the application that ammonia anhydrous is used in their country as a surface disinfectant for use in a range of animal housings or enclosures, and for a range of livestock types (e.g. poultry, game birds, rabbits, cattle, pigs and sheep). It is aimed at reducing the disease challenge of coccidia, cryptosporidia, nematodes and other protozoa by reducing the environmental load of the disease causing organisms.

According to the French CA, for the more persistent protozoa like coccidia, ammonia appears to be the most effective method of control currently employed within their territory. The French CA are of the opinion that ammonia is a suitable bridge between current solutions and a new product currently being worked on for full Annex I inclusion and that it does meet the criteria for essential use on the following grounds:

 Other alternatives for killing coccidia use the same active substance (p-chloro-m- cresol), which may lead to resistance.

 P-chloro-m-cresol may not gain Annex 1 listing; therefore the possibility of being left with no product exists.

 the impression is that ammonia is the most effective method for disinfecting areas with coccidia.

 a replacement for ammonia is currently being developed; it is expected to be available before May 2010.

1 http://ec.europa.eu/environment/biocides/essential_uses.htm 1 WORKING DOCUMENT: DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION

Therefore, the French CA considers acceptable to keep ammonia on the market until this replacement is available.

A biocidal product that has ammonia as the active substance is currently produced and placed on the French market by the company DuPont, which is however not intending to submit a dossier with a view to maintain ammonia on the French market. The French CA has however indicated that an alternative product to the use of ammonia is under development by DuPont and that it should be available before May 2010.

Received comments

The UK and Austrian CA supported the granting of derogation for ammonia anhydrous; the UK CA has submitted on 30 March 2006 a similar application for ammonia anhydrous, which was favourably received (marketing extension granted up to 14 May 2008).

The companies Lanxess (producer of p-chloro-m-cresol) and Menno Chemie (formulator of Neopredisan 135-1 which uses p-chloro-m-cresol) contest the French application, claiming that ammonia is lacking efficacy; that it is not the only active substance in OO- Cide (DuPont's product); and that they have the intention to submit a dossier for p- chloro-m-cresol (declaration of Dr Knoell Consult that they are preparing the dossier for Lanxess). They argue further that due to the mode of action of phenolics they do not share the concern that only one disinfectant may lead to the development of resistance by the target harmful organisms.

Conclusions

The Commission, having reviewed all the information and comments submitted, recognises, one the one hand, that there is a limited number of substances, which can be used in France against coccidia and cryptosporidia in product-type 3 (veterinary hygiene biocidal products) and that, considering that all the alternatives available rely on the same active substance, there seems to exist a possibility of resistance development. It would be therefore appropriate to have at least another product on the market containing a different active substance.

The Commission noted that the company placing ammonia anhydrous on the French market is not intending to submit an application with a view to get the substance included in Annex I of Directive 98/8/EC. However, the same company is working on a replacement product, which should be available by May 2010.

The Commission considers that the conditions of Article 4a(1) are met and that the use of ammonia anhydrous for product-type 3 should be regarded as essential in France.

The Commission therefore proposes to grant an extension of the period laid down in Article 4(2) of Regulation (EC) N°2032/2003 for placing ammonia anhydrous for product-type 3 on the market of France until 14 May 2008.

The Commission however considers that the use of ammonia anhydrous must be restricted to situations where no other active substance can be used.

In addition, the French CA should submit regular reports on the progress of compiling a dossier for the replacement product.