EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12510/2019 Rev. 1  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for chlordecone in or on certain 
products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for chlordecone in or on certain 
products  
(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  396/2005 of the European Parliament and of the 
Council of 23  February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article 14(1)(a)  in conjunction with Article 16(1)(a) thereof,  
Whereas:  
(1) For chlordecone , maximum residue levels (MRLs) were set in Annex  III to Regulation 
(EC) No  396/2005.  
(2) Regulation (EC) No 850/2004 of the European Parliament and of the Council2 
prohibited the placing on the market and use of plant protection products containing 
chlordecone. Residues of chlordecone  are resulting from environmental contamination 
in soil due to the use of this persistent compound in the past.  
(3) On 12 July 2019, the F rench competent authorities notified to the Commission two 
emergency measures34, which had been taken at national level pursuant to Article  54 
of Regulation (EC) No 178/2002  of the European Parliament and of the Council5. 
Following the opinions67 of the Fr ench Agency for Food, Environmental and 
Occupational Health & Safety (ANSES), France had fixed national MRLs for 
chlordecone in bovine, ovine, caprine, porcine and poultry products  at lower values 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on 
persistent organic pollutants and amending Directive 79/117/EEC  (OJ L 158, 30.4.2004, p. 7 ). 
3 Arrêté du 25 janvier 2019 modifiant l'arrêté du 30 juin 2008 relatif aux limites maximales applicables 
aux résidus de chlordécone que ne doivent pas dépasser certaines denrées alimentaires d'origine 
végétale et animale pour être reconnues propres à la cons ommation humaine ( NOR: AGRG1901040A ). 
4 Arrêté d u 23 mai 2019 modifiant l’arrêté du 25 janvier 2019 relatif aux limites maximales applicables 
aux résidus de chlordécone que ne doivent pas dépasser certaines denrées alimentaires d’origine 
végétale et animale pour être reconnues propres à la consommation humaine  (NOR : AGRG1913466A ). 
5 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safe ty. OJ L 31, 1.2.2002, p. 1.  
6 Note d’appui scientifique et technique de l’Agence nationale de sécurité sanitaire de l’alimentation, de 
l’environnement et du travail relative à la fixation d’une limite maximale de résidus de chlordécone 
dans la graisse pou r les denrées carnées  (2018 -SA-0202 ). 
7 Avis de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail 
relatif à la fixation d’une limite maximale de résidus de chlordécone dans les muscles et dans la graisse 
pour les denrées carnées  (2018 -SA-0265 ). EN 2  EN than the ones currently appl icable under Regulation (EC) No  396/2005 , to ensure the 
protection of consumers in Guadeloupe and Martinique . 
(4) The Commission requested the European Food Safety Authority ('the Authority')  to 
carry out a consumer exposure assessment in relation to the MRLs recommended by 
ANSES for chlord econe in products of animal origin.  
(5) The Authority submitted a scientific statement for chlordecone in certain products of 
animal origin8 in accordance with Article 43 of Regulation (EC ) No 396/2005 . In that 
statement , the Authority concluded that the MRLs  proposed in the opinions of  ANSES 
for animal products , are acceptable  with regard to consumer safety.  Neither the 
lifetime nor the short -term exposure due to high consumption of the relevant products 
showed that there is a risk that the acceptable daily intake or the acute reference dose 
is exceeded . The MRLs for chlordecone  should be set as temporary in Annex III to 
Regulation (EC) No 396/2005. Those MRLs will be reviewed; the review will take 
into account the information available within 10 years from t he publication of this 
Regulation.  
(6) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(7) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(8) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modificat ion of the MRLs.  
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III  to Regulation (EC) No  396/2005 is amended in acco rdance with the Annex to this 
Regulation.  
Article 2 
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 [ Office of Publication: please insert date 6 months after entry into force ]. 
                                                 
8 Statement on the dietary exposure assessment for the temporary maximum residue levels for chlordecone 
in certain products of animal origin . EFSA Journal 2020;18(3):6052 . EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN