EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11270/2020 feedback 
(POOL/G4/2020/11270/11270 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2019/625 as regards import conditions for live 
snails, for composite products and for casings placed on the market for human 
consumption  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) 2017/625 of the European Parliament and of the Council lays down 
rules for the performance of official controls and other control activities by the 
competent authorities of the Member States , including for the establishment of 
requirements to be fulfilled for the entry into the Union of consignments of animals 
and goods from thir d countries or regions thereof and official controls performed on 
such consignments that are intended for human consumption in order to ensure that 
they comply with Union legislation in the area of food and food safety.  
Delegated Regulation (EU) 2019/625 s upplement s Regulation (EU) 2017/625 of the 
European Parliament and of the Council with regard to requirements for the entry 
into the Union of consignments of certain animals and goods intended for human 
consumption . 
This amendment of Delegated Regulation ( EU) 2019/625 extends import conditions 
to live snails to ensure safe imports from Third Countries to the EU of live snails 
intended for human consumption. In addition, Harmonized System codes for 
composite products are added . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
This Delegated Regulation  has been discussed on 5 Jun e 2020  at the meeting of the  
expert group on food hygiene and control of food of animal origin , representing 
competent authorities of all Member States, and is supported by these experts.  
Before adopting this Delegated Regulation, the Commission conducted public 
consultations in an open and transparent way in accordance with the procedures laid 
down in the Interinstitutional Agreement on Better Law -Making . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Commission Delegated Regulation (EU) 2019/625 and its amendments are adopted 
pursuant to Article  126(1)  of Regulation (EU)  2017/625, which became applicable 
with effect from 14 December 2019.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2019/625 as regards import conditions for live snails, for 
composite products and for casings placed on the market for human consumption  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 
2017 on official controls and other offic ial activities performed to ensure the application of food and feed 
law, rules on animal health and welfare, plant health and plant protection products, amending Regulations 
(EC) No 999/2001, (EC) No 396/2005, (EC) No  1069/2009, (EC)  No 1107/2009, (EU) No 1151/2012, (EU) 
No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations (EC) No  1/2005 and (EC) No  1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No  854/2004 and (EC) 
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 
90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official 
Controls  Regulation)1, and in particular Article 126(1)  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) 2019/6252 lays down the requirements  for the entry into the 
Union  consign ments  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 certificat e. Simila r requirements should also appl y 
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 introduce d in Delegated Regulation (EU) 2019/625 . 
(4) Article 12 o f Delegated  Regulation (EU ) 2019/625 provides for import requirements for 
consignments of composite products  referred to by  Harmoni sed System  codes  (‘HS codes’) under 
certain headings of Part Two of Annex I to Council Regulation (EEC) No 2658/873 . Certain  
composite products referred to by HS codes  are missing  in Article 12 of Delegated Regulation (EU ) 
2019/625 . It is there fore appropriate to add these  HS 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 
                                                 
1 OJ L  95, 7.4.2017, p.1  
2 Commission delegated regulation (EU) 2019/625 of 4 March 2019 supplementing  Regulation (EU) 2017/625 of the 
European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of 
certain animals and goods intended for human consumption (OJ L 131, 14.5.2019 , p.19) 
3 Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common 
Customs Tariff (OJ L 256, 7.9.1987, p. 1).   
EN 3  EN requirements also contribu tes 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 if 
raw materia ls 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 u sed 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 casings come from slaughterhouses under the 
supervision of the national com petent authorities and Article 7 should be amended accordingly . 
(7) Article 13 of Delegated Regulation (EU) 2019/625 establishes that e ach 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 accompan ied by an official 
certificate.  
(8) The risk related 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 complianc e 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 containing  meat -derived  products such as gelatine or 
collagen or highly refined products that, because of the nature of their treatment, are not representing 
a public or animal health risk. Those products should be  accompanied by a private attestation instead 
of an official certifi cate. 
(10) Delegated Regulation (EU) 2019/625 should therefore be amended accordingly.  
(11) As Article 12 of Delegated Regulation (EU) 2019/625 applies from 21 April 2021, the amendments 
to Article 12 should also apply from that date , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Delegated Regulation (EU) 2019/625 is amended as follows:  
(1) in Article 1 (2)(d) , the following point (v) is added : 
‘(v) live snails .’.; 
(2) in Article 2, the following point (14)(a) is inserted:  
‘(14)(a) “'snails' ” means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 
and any other  species of  snails of the family of Helicidae, Hygromiidae  or Sphincterochilidae , 
intended for human consumption ;’.; 
(3) in Article 3, the following point (c) is inser ted: 
‘(c) live snails referred to by the CN code 0307 60 00  of Part Two of Annex I to Regulation (EEC) 
No 2658/87 .’ 
(4) Article 7 (d) is replaced by the following : 
‘(d) mechanically separated  meat  and meat products excluding casings  as defined in point 45 of 
Article 2 to Commission Delegated Regulation (EU) No 2020/692 ’ 
(5) Article 12 (1) is replaced by the following:   
EN 4  EN ‘1. Consignments of composite products referred to by the HS codes under headings 1601, 1602, 
1603, 1604, 1605, 1704, 1806 20, 1806 31, 1806 32, 1806 90 11, 1806 90 19, 1806 90 31, 1806 90 
39, 1806 90 50 1901, 1902, 1905, ex 2001 90 65, 2004, 2005, 2101, 2103, 2104, 2105, 2106 of Part 
Two of Annex I to Regulation (EEC) No 2658/87 shall enter the Union for placing on the market 
only if each processed pro duct of animal origin contained in the composite products was either 
produced in establishments that are located in third countries or regions thereof and authorised to 
export those processed products of animal origin to the Union in accordance with Articl e 5 or in 
establishments located in Member States ’ 
(6) Article 13 (1) is amended as follows:  
(a) the following p oint ( d) is inserted : 
‘(d) live snails referred to by the CN code 0307 60 00  of Part Two of Annex I to Regulation 
(EEC) No 2658/87 ;’ 
(b) the following point (e) is inserted:  
’(e) composite products referred t o in Article 12 (2)(a) and (b)  with the exclusion of shelf 
stable composite products only containing gelatine, collagen or highly refined products 
deriv ed from meat .’ 
(7) Article 14 (1) is replaced by the foll owing:  
‘1. A private attestation confirming that the consignments comply with the applicable 
requireme nts referred to in Article 126(2 ) of Regulation (EU) 2017/625, prepared and signed by the 
importing food business operator, shall accompany the consignmen ts of the composite products as 
referred to in  
(8) Article 12(2)(b) where the composite products do not contain any other meat products than gelatine, 
collagen or highly refined products deriv ed from meat , and 
(9) Article 12(2)(c) .’ 
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 . 
Article 1  (4), (6)(b) and (7) shall apply from 21 April 2021.  
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