
Article 1 

1. This Regulation shall apply to a detoxification process through which an undesirable substance listed in Annex I of Directive 2002/32/EC is on purpose removed from non-compliant contaminated feed, hereinafter ‘physical detoxification process’, broken down or destroyed by a chemical substance into harmless compounds, hereinafter ‘chemical detoxification process’, or metabolised or destroyed or deactivated by a (micro)biological process into harmless compounds, hereinafter ‘(micro)biological detoxification process’.
2. This Regulation shall not apply to a simple detoxification process through which the contamination by an undesirable substance is reduced or eliminated by a usual refining process, cleaning, sorting or mechanical removal of contaminants or certain parts of the contaminated feed.
(3.) The following definitions apply for the purpose of this Regulation—
(a) “appropriate authority” means—
(i) in relation to England; the Secretary of State;
(ii) in relation to Wales; the Welsh Ministers;
(iii) in relation to Scotland; the Scottish Ministers;
(b) “Food Safety Authority” means—
(i) as regards England and Wales, the Food Standards Agency;
(ii) as regards Scotland, Food Standards Scotland.
Article 2 
A detoxification process shall only be applied if:

— the process is exclusively intended for the detoxification of feed in which the non-compliance as regards Directive 2002/32/EC does not result from an on purpose non-compliance to the requirements set out in articles 4 and 5 of Regulation (EC) No 183/2005,
— the Food Safety Authority has performed, on request of the appropriate authority, a scientific assessment of the detoxification process, and concluded that the detoxification process complies with the acceptability criteria, as set out in Articles 3, 4 and 5.
Article 3 

1. A scientific assessment shall be performed by  the Food Safety Authority  on a physical detoxification process assessing if the following criteria are met:
(a) the process is effective;
(b) the process does not adversely affect the characteristics and the nature of the feed; and
(c) a safe disposal of the removed part of the feed is guaranteed.
2. The information which the feed business operator shall provide to the  appropriate authority  for the purpose of the assessment of such a process is listed in point 1 of the Annex.
Article 4 

1. A scientific assessment shall be performed by  the Food Safety Authority  on a chemical detoxification process assessing if the following criteria are met:
(a) the process is performed with a fully characterised and acceptable chemical substance;
(b) the process is effective and irreversible;
(c) the process does not result in harmful residues of the chemical substance used in the detoxification process in the detoxified feed;
(d) the process does not result in reaction products of the contaminant that endanger animal and public health and the environment; and
(e) the process does not adversely affect the characteristics and the nature of the feed.
2. The information which the feed business operator shall provide to the  appropriate authority  for the purpose of assessment of such a process is listed in point 2 of the Annex.
Article 5 

1. A scientific assessment shall be performed by  the Food Safety Authority  on a (micro)biological detoxification process assessing if the following criteria are met:
(a) the process is performed with a fully characterised and acceptable (micro)biological agent;
(b) the process is effective and irreversible;
(c) the process does not result in harmful residues of the (micro)biological agent used in the detoxification process in the detoxified feed;
(d) the process does not result in metabolites of the contaminant that endanger animal and public health and the environment; and
(e) the process does not adversely affect the characteristics and the nature of the feed.
2. The information which the feed business operator shall provide to the  appropriate authority  for the purpose of assessment of such a process is listed in point 3 of the Annex.
Article 6 

1. Feed business operators shall ensure that establishments under their control and covered by Regulation (EC) No 183/2005 are approved by a competent authority, as defined in Article 3(e) of Regulation (EC) No 183/2005, where such establishments carry out a detoxification process referred to in Article 1. The approval shall be carried out in accordance with Article 10(3) of Regulation (EC) No 183/2005.
2. The competent authority, referred to in point 1, may require that the feed business operator provides independent expert advice in order to decide on the acceptability of the application of the detoxification process in the relevant establishment, ensuring a correct and effective application of the detoxification process in the establishment.
3. The national list of approved establishments, as defined in Article 19(2) of Regulation (EC) No 183/2005, shall mention for the establishments, approved for carrying out a detoxification process, the accepted detoxification process. ...
Article 7 
In case of an urgent need to decontaminate a large amount of feed with a detoxification process not yet assessed by  the Food Safety Authority, the  appropriate authority  may request to the Food Safety Authority on request of a competent authority to provide within a short period of time for an assessment of the detoxification process to enable, in case of a favourable outcome, for a defined short period of time, the detoxification of specifically identified contaminated consignments. The use of this detoxification process on a wider scale for an undetermined period of time is only allowed after the Food Safety Authority has performed a comprehensive scientific assessment with favourable outcome.
Article 8 
Feed business operators using before the entry in application of the Regulation a detoxification process which has been favourably assessed by the EFSA before the application of this Regulation or which have provided the necessary information as provided for in Annex to the Commission before 1 July 2016 but EFSA has not finalised the assessment at the time of application of this Regulation, are allowed to continue to apply the detoxification process awaiting the decision of the competent authority as regards the acceptability of the application of the detoxification process in the relevant establishment.
Article 9 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2017.
...Done at Brussels, 19 May 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX
1. 
The following elements shall be provided to the  appropriate authority  per matrix (feed material, compound feed, any other product intended for animal feeding):


((a)) data on the efficiency of the physical detoxification process to remove the contamination from the batch of feed, so that the batch of feed complies with the requirements of Directive 2002/32/EC;
((b)) evidence that the physical detoxification process does not adversely affect the characteristics and the nature of the feed; and
((c)) guarantees for safe disposal of the removed part of the feed.

2. 
The following elements shall be provided to the appropriate authority per matrix (feed material, compound feed, any other product intended for animal feeding):


((a)) evidence that the detoxification process is effective, in the sense that the detoxified feed complies with the requirements of Directive 2002/32/EC, and irreversible;
((b)) evidence that the detoxification process does not result in harmful residues of the chemical substance used for the detoxification (as parent compound or as reaction product) in the detoxified product;
((c)) detailed information on the chemical substance, the mode of action of the chemical substance as regards the detoxification process and the fate of the chemical substance;
((d)) evidence that the reaction products of the contaminant, formed after the performance of the detoxification process, do not endanger animal and public health and the environment;
((e)) evidence that the detoxification process does not adversely affect the characteristics and the nature of the feed to be detoxified.

3. 
The following elements shall be provided to the appropriate authority per matrix (feed material, compound feed, any other product intended for animal feeding):


((a)) evidence that the detoxification process is effective in the sense that the detoxified feed complies with the requirements of Directive 2002/32/EC, and irreversible;
((b)) evidence that the detoxification process does not result in harmful residues of the (micro)biological agent used for the detoxification (as parent compound or as metabolite) in the detoxified product;
((c)) evidence that the detoxification process does not result in surviving microorganisms with decreased susceptibility to the detoxification process;
((d)) detailed information on the mode of action of the (micro)biological agent as regards the detoxification process and the fate of the (micro)biological agent;
((e)) evidence that the metabolites of the contaminant, formed after the performance of the detoxification process, do not endanger animal and public health and the environment;
((f)) evidence that the detoxification process does not adversely affect the characteristics and the nature of the feed to be detoxified.
