(1)

The Annex to Regulation (EU) No 609/2013 establishes a Union list of substances that may be added to one or more of the categories of food referred to in Article 1(1) of that Regulation.

(2)

The Annex to Regulation (EU) No 609/2013 currently authorises the addition of calcium L-methylfolate as a source of folate to food for special medical purposes and to total diet replacement for weight control.

(3)

Following an application requesting that the use of calcium L-methylfolate as a source of folate is authorised also in infant formula, follow-on formula, processed cereal-based food and baby food, at the levels necessary to meet the compositional requirements for folate set out by the Union legislation for those foodstuffs, the Commission requested the European Food Safety Authority (‘the Authority’) to provide an opinion on the safety and bioavailability of that substance when added to the concerned foodstuffs. In its opinion of 27 November 2019 (2), the Authority concluded that calcium L-methylfolate is a source from which folate is bioavailable and that it is safe under the proposed uses and use levels for the target population that is infants (< 12 months) and young children (12-< 36 months).

(4)

The Commission considers that the Authority’s opinion gives sufficient grounds to establish that calcium L-methylfolate is not of a safety concern as a source of folate when used in infant formula, follow-on formula, processed cereal-based food and baby food at the required levels. Therefore, calcium L-methylfolate should be included in the list set out in Annex to Regulation (EU) No 609/2013, as a source of folate in those categories of foods.

(5)

Regulation (EU) No 609/2013 should therefore be amended accordingly.

(1)

Commission Delegated Regulation (EU) 2016/127 (2) lays down, amongst others, specific compositional requirements for infant and follow-on formula manufactured from protein hydrolysate. Delegated Regulation (EU) 2016/127 provides that its provisions on infant and follow-on formula manufactured from protein hydrolysates apply from 22 February 2021.

(2)

The use of protein hydrolysates as a source of protein in infant formula and follow-on formula has been allowed under Commission Directive 2006/141/EC (3). However, in its opinion on the essential composition of infant and follow-on formulae (4), the European Food Safety Authority (‘Authority’) noted that the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation.

(3)

Only one of the formulae currently on the market has received a positive assessment by the Authority so far. Its composition corresponds to the requirements provided in Delegated Regulation (EU) 2016/127.

(4)

The Authority is currently assessing the safety and suitability of a number of other compositions, corresponding to formulae currently lawfully placed on the market in accordance with Directive 2006/141/EC.

(5)

The requirements provided in Delegated Regulation (EU) 2016/127 may be updated in order to allow the placing on the market of formula manufactured from protein hydrolysates with a composition different from the one already positively assessed, following a case-by-case evaluation of their safety and suitability by the Authority.

(6)

However, the COVID-19 pandemic and the associated public health crisis caused unexpected delays in the scientific assessments of the formulae currently under evaluation by the Authority.

(7)

In order to avoid potential market disruptions, it is necessary to defer the application of the requirements for infant formula and follow-on formula manufactured from protein hydrolysates by a period of time considered appropriate to compensate the effects of the COVID-19 pandemic on the evaluation carried out by the Authority.

(8)

In light of the need to avoid market disruptions, this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.

(9)

Commission Delegated Regulation (EU) 2016/127 should therefore be amended accordingly,

(1)

Commission Delegated Regulation (EU) 2019/625 (2) lays down the requirements for the entry into the Union consignments of, inter alia, prepared snails.

(2)

According to Article 1(2)(a)(i) and (iii) of Delegated Regulation (EU) 2019/625, third countries exporting consignments of prepared snails to the Union are to be listed, and each consignment of prepared snails is to be accompanied by an official certificate. Similar requirements should also apply to live snails intended for human consumption.

(3)

To clearly identify the snails subject to requirements for entry into the Union, a definition of snails should be introduced in Delegated Regulation (EU) 2019/625.

(4)

Delegated Regulation (EU) 2019/625 should not apply to samples of goods intended for human consumption, imported for the purpose of product analysis and quality testing without being placed on the market and therefore do not represent a risk to public health. Article 1(3) should be amended accordingly. Article 12 of Delegated Regulation (EU) 2019/625 provides for import requirements for consignments of composite products referred to by Harmonised System codes (‘HS codes’) under certain headings of Part Two of Annex I to Council Regulation (EEC) No 2658/87 (3). It is appropriate to refer to Combined Nomenclature (CN) codes in accordance with Regulation (EU) 2017/625. In addition, codes of certain composite products are missing in Article 12 of Delegated Regulation (EU) 2019/625. It is therefore appropriate to add these CN codes.

(5)

Consignments of live snails and of composite products placed on the market for human consumption should be subject to individual certification for entry into the Union to reduce the risk of non-compliance with Union requirements on food safety. Certification of compliance with Union requirements also contributes to reminding food business operators and the competent authorities of third countries or regions thereof of the applicable Union requirements.

(6)

Article 7 of Delegated Regulation (EU) 2019/625 provides for requirements on the manufacturing of raw materials for import of consignments of fresh meat, minced meat, meat preparations, meat products, mechanically separated meat and raw materials intended for the production of gelatine and collagen to avoid a possible public health risk. Bladders and intestines used for the production of casings, are subject to a treatment that eliminates any public health risk. It is therefore appropriate to allow that the raw materials for the production of casings come from slaughterhouses under the supervision of the national competent authorities and Article 7 should be amended accordingly.

(7)

Article 13 of Delegated Regulation (EU) 2019/625 establishes that each consignment of certain listed products may enter the Union only if the consignment is accompanied by an official certificate. Composite products are not included in the list of products that are to be accompanied by an official certificate.

(8)

The risk related to certain categories of composite products depends on the type of ingredients and on their storage conditions. Consignments of such products placed on the market for human consumption should therefore be subject to the individual certification of each consignment for entry into the Union for placing on the market. Certification of compliance with Union requirements may also contribute to reminding food business operators and the competent authorities of third countries or regions thereof of the applicable Union requirements.

(9)

Certain shelf-stable composite products that do not contain any other meat products than gelatine or collagen or highly refined products do not represent a public or animal health risk because of the nature of the treatment required for the manufacture of such meat products. Such composite products should be accompanied by a private attestation instead of an official certificate.

(10)

Delegated Regulation (EU) 2019/625 should therefore be amended accordingly.

(11)

As Articles 12 and 14 of Delegated Regulation (EU) 2019/625 applies from 21 April 2021, the amendments to Articles relevant for these Articles 12 and 14 should also apply from that date,

(1)

Commission Implementing Regulation (EU) 2017/375 (2) renewed the approval of the active substance prosulfuron as a candidate for substitution in accordance with Regulation (EC) No 1107/2009.

(2)

The approval of the active substance prosulfuron, as set out in Part E of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3), included a restriction that the use of prosulfuron was to be limited to one application every three years on the same field at a maximum dose of 20 g active substance per hectare.

(3)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 12 October 2016, Syngenta Crop Protection AG submitted an application to the designated rapporteur Member State, France, seeking an amendment to the conditions of approval of prosulfuron in order to remove that restriction. The application was found to be admissible by the designated rapporteur Member State.

(4)

The designated rapporteur Member State assessed the amended use of the active substance prosulfuron in relation to the potential effects on human and animal health and the environment in accordance with the provisions of Article 4 of Regulation (EC) No 1107/2009, and prepared a revised renewal assessment report which was submitted to the European Food Safety Authority (‘the Authority’) and the Commission on 5 April 2018.

(5)

In accordance with Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the revised renewal assessment report to the applicant and to the Member States for comments and made it available to the public. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, additional information was requested from the applicant. France evaluated the additional information and submitted a revised renewal assessment report to the Commission and to the Authority on 28 February 2019.

(6)

On 15 June 2020, the Authority communicated to the Commission its conclusion (4) on whether the amended use of the active substance prosulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(7)

The Commission presented an addendum to the review report for prosulfuron and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 23 October 2020.

(8)

The applicant was invited to submit comments on the addendum to the review report.

(9)

It has been established with respect to one or more representative uses of at least one plant protection product containing prosulfuron that, when the plant protection product is applied annually, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to remove the restriction limiting the use of prosulfuron to one application every three years on the same field at a maximum dose of 20 g active substance per hectare.

(10)

Implementing Regulations (EU) 2017/375 and (EU) No 540/2011 should therefore be amended accordingly.

(11)

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

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4)

It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,