Dr David Jukes, The University of Reading, UK

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Food Law News - EU - 2016

Commission Draft Regulation, 19 October 2016

HYGIENE/IMPORTS - Draft implementing regulation - Import conditions for foodstuffs from non-EU countries due to microbiological contamination

The Commission has published a draft implementing regulation for consultation.  It follows continued detection of salmonella in sesame seeds and betel leaves imported from India.  The following are the recitals from the draft regulation.  For full details, see the following:

To see the consultation page, go to:

Having regard to 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 safety1, and in particular Article 53(1)(b)(ii) thereof,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules2, and in particular Article 15(5) thereof,


(1) Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for food imported from a third country in order to protect human health, animal health and the environment, where it is evident that there is a serious risk that cannot be contained satisfactorily by means of measures taken by the Member States individually.

(2) Article 11 of that Regulation requires that food imported into the Union for placing on the market within the Union is to comply with the relevant requirements of food law or conditions recognised by the Union to be at least equivalent thereto or, where a specific agreement exists between the Union and the exporting country, with requirements contained therein.

(3) Regulation (EC) No 852/2004 of the European Parliament and of the Council3 lays down general rules for food business operators on the hygiene of foodstuffs.

(4) Article 11 of Regulation (EC) No 882/2004 sets the requirements for sampling and analysis methods used in the context of official controls.

(5) Article 14 of Regulation (EC) No 178/2002 provides that unsafe food products are not to be placed on the market. According to Regulation (EC) No 882/2004, the Competent Authorities are to verify the food business operators' compliance with Union legislation.

(6) Commission Regulation (EC) No 669/20094 lays down rules concerning the increased level of official controls on imports of certain feed and food of non-animal origin listed in Annex I to that Regulation.

(7) For many years, there has been a high frequency of non-compliance with microbiological safety issues in sesame seeds ('Sesamum seeds') and betel leaves ('Piper betle L.') from India. An increased frequency of official controls on import of those foods has therefore been established in 2014 with regard to the presence of Salmonella spp. Nonetheless these increased controls confirmed the high frequency of non-compliance of those foods with microbiological safety due to Salmonella spp. The import of those foods constitutes therefore a serious risk to public health within the Union and it is therefore necessary to adopt Union emergency measures.

(8) Guarantees from the competent authorities of exporting countries that those foods have been produced in line with the hygiene provisions set up in Regulation (EC) No 852/2004 are necessary to protect human health in the Union. In order to ensure harmonised enforcement of import controls across the Union, all consignments of such foods should be accompanied by a health certificate signed by the competent authorities of exporting countries and by the results of analytical tests guaranteeing that they have been sampled and analysed with satisfactory results for the presence of microbiological pathogens.

(9) Article 6 of Commission Regulation (EC) No 669/2009 requires the food business operators, responsible for consignments, to give prior notification of the arrival and nature of such consignments at the designated point of entry (DPE).

(10) Article 8 of Commission Regulation (EC) No 669/2009 requires, with regard to the increased level of official controls, those controls to cover documentary, identity and physical checks. Documentary checks are to be carried out without undue delay on all consignments within 2 working days from the time of arrival at the DPE and identity and physical checks, including laboratory analysis, at the frequencies set out in Annex I to that Regulation.

(11) In order to ensure an efficient organisation and harmonised import controls at Union level with regard to the presence of microbiological pathogens in certain foods from certain third countries, specific import conditions for such foods should be laid down. For legal clarity, it is appropriate to gather all foods from third countries subject to specific conditions because of microbiological risks into one Regulation. Therefore the provisions regarding Betel leaves from India laid down in Commission Implementing Regulation (EU) No 2016/1665 should be inserted into this Regulation and Regulation (EC) No 669/2009 should be amended accordingly.

(12) Commission Implementing Regulation (EU) No 2016/166 should be repealed and replaced simultaneously by a more general Regulation laying down the provisions as regards import of certain foods from certain third countries due to microbiological contamination

(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.

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