EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 1235/2008 as regards the electronic certificate of 
inspection for imported organic products and certain other elements, and Regulation 
(EC) No 889/2008 as regards the requirements for preserved or processed organic 
products and the transmission of information  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending  Regulation (EC) No 1235/2008 as regards the electronic certificate of 
inspection for imported organic products and certain other elements, and Regulation 
(EC) No 889/2008 as regards the requirements for preserved or processed organic 
products and the tran smission of information  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic 
production and labelling of org anic products and repealing Regulation (EEC) No 2092/911, 
and in particular Article 38  (a), (d) and (e) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 1235/20082 lays down detailed rules for imports of 
organic products from third countries . 
(2) A period for the control bodies and control authorities to submit their request for 
recognition for the purpose of compliance in accordance with Article 32 of Regulation 
(EC) No 834/2007  is provided for in Regulation (EC) No 1235/2008 . As the 
implementation  of the provisions regarding the import of compliant products is still 
under assessment and the related guidelines, models, questionnaires and the necessary 
electronic transmission system are still under development, the deadline for the 
submission of requ ests by control bodies and control authorities should be extended.  
(3) Experience has shown diverging practices in Member States as regards the verification 
of the consignments of organic products prior to their release for free circulation into 
the Union. For  the sake of consistent and effective controls, the  types of checks 
necessary for  the verification of the consignments should be clarified , in the light of 
the risk assessment to be carried out in accord ance with  Article 27(3) of Regulation 
(EC) No 834/200 7. It is also appropriate to reword  the definition of the authorities 
responsible for the verification of the consignments and the endorsement of the 
certificates of inspection  in order to clarify that those authorities are a competent 
authority  responsibl e for the organisation  of official controls in the field of organic 
production and designated pursuant  to Article 27(1) of Regulation (EC) No 834/2007 . 
(4) Diverging practices by control bodies  and control authorities  have also been observed 
as regards the classification of products to be imported under the product categories 
referred to in Annexes III and IV to Regulation (EC) No 1235/2008 . For a more 
                                                 
1 OJ L 189, 20.7.2007, p. 1.  
2 Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for 
implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of 
organic products from third countries (OJ L 334, 1 2.12.2008, p. 25)  EN 3   EN uniform classification under those product categories certain definitions should 
therefore be laid down in the interest of  clarity and legal certainty for operators, to 
ensure uniform i mplementation of the rules by the control bodies  and control 
authorities , and to facilitate supervision by the competent authorities.  
(5) For product categories referring to unprocessed  or processed, t hose terms should have 
the same meaning as in the  definitions of processed and unprocessed products in 
Regulation (EC) No 852/2004 of the European Parliament and of the Council3 with a 
view to simplification and consi stency with the hygiene  rules . However, it should be 
clarified that labelling and packaging operations are irrelevant for the qualification of 
the product as  unprocessed or processed.  
(6) The two import schemes provided for in Article 33(2) and (3) of Regulation (EC) No 
834/2007 are , in principle, mutually exclusive. If a third country is recognised  as 
equivalent  in accordance with Article 33(2) of  Regulation (EC) No 834/2007, there is 
no need to recognise  a control authority or control body for that country in  accordance 
with Articl e 33(3). As a consequence, Article 10(2)( b) of Regulation (EC) No 
1235/2008 provides that a control authority or control body can only be recognised in 
accordance with Article 33(3) of Regulation (EC) No 834/2007 for a country that is 
not recognised in accordance with Article 33(2) of Re gulation (EC) No 834/2007. 
However, in order to avoid any barrier to imports for organic products, it should be 
possible for control bodies or control authorities to be recognised  for a recognised  
third country where the rec ognition of that third country does not cover the product to 
be imported. The existing derogation in Article 10(3) of Regulation (EC) No 
1235/2008  should therefore be reworded to take into account the practice in place by 
referring to products rather than to the category of products.  
(7) On the basis of Regulation (EC) No 834/2007 products imported from a third country 
may be placed on the Union market as organic if they, in particular, are covered by a 
certificate of inspection issued by the competent authorities, control authorities or 
control bodies of  a recognised  third country or by a recognised  control authority or 
control body.  
(8) In accordance with Action 12 of the Action Plan for the Future of Organic Production 
in the E uropean Union4 the Commission has developed  a system of electronic 
certification  for import s of organic products , as a module integrated into the electronic 
Trade Control and Expert S ystem (TRACES)  provided for in Commission Decision 
2003/24/EC5. 
(9) Certain provisions of Regulation (EC) No 1235/2008 need to be amended in order to 
introdu ce the electronic certification system and to ensure the proper functioning of 
that system . Therefore , the rules for the release for free circulation by the relevant 
Member State's customs authority and the workflow for the issuing and endorsing of 
the cer tificate of inspection , including  the verification of the link between the 
certificate of inspection and the customs declaration,  should be clarified.  In this 
context, t he workflow for the issu e and endors ement  of the certificate of inspection 
under special customs procedures should also be clarified.  For the proper functioning 
                                                 
3 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 
hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).  
4 COM(2014)179 final  
5 Commission Decision 2003/24/EC of 30 December 2002 concerning th e development of an integrated 
computerised veterinary system (OJ L 8, 14.1.2003, p. 44).  EN 4   EN of the electronic system, it is appropriate to refer to e -mail addresses of recognised  
control  bodies and control authorities . 
(10) In order to ensure the integrity of the organic products  imported into the Union , it is 
necessary to clarify  that, as a general rule, the control body or control authority issuing 
the certificate of inspection is the control body or authority certifying  the produce r or 
the processor of the product. In case the operator carrying out  the last operation for the 
purposes of preparation as defined in Article 2(i) of Regulation (EC) No 834/2007 is 
different from the original producer or processor of the product, the certi ficate of 
inspection should be issued by the  control body or control authority having checked 
the last operation. Furthermore, it is necessary to clarify that control bodies or control 
authorities listed in Annex III to Regulation (EC) No 1235/2008 may  only issue 
certificates of inspection according to the terms of t heir recognition , while  those  listed 
in Annex IV to that Regulation may  only issue certificates of inspections for the 
products and origins  for which they are listed for.  
(11) Experience has shown diverging practices as regards checks to be carried out  by the 
control body or control authority issuing the certificate of inspection. Therefore, it is 
necessary to specify  the checks to be carried out  prior to issuing the certificate . Control 
bodies or control authorities should  only issue the certificate of inspection after full 
documentary checks and, as appropriate according to their risk assessment, physical 
checks of the products  concerned . For processed agricultural products , control bodies 
and control authorities listed in Annex III to Regulation (EC) No 1235/2008 should 
check that  all their ingredients have been submitted to a control system in accordance 
with the terms of recognition of the relevant third country , while contro l bodies and 
control authorities listed in Annex IV to that Regulation should  check that ingredients 
have been controlled and certified by control bodies or control authorities recognised 
in accordance with Union legislation or produced in the Union. Similarly it is 
necessary to specify the  checks to be carried out  by control bodies or control 
authorities listed in Annex IV to Regulation (EC) No 1235/2008 that  certify operators 
in the final stages of the production chain, such as those only carrying ou t labelling or 
packaging operations. In such cases, it should be verified that the products  concerned  
have been controlled and certified by control bodies or control authorities listed in that 
Annex and recognised for the relevant country and product categ ory.  
(12) The authorities responsible for granting and updating the rights to access TRACES for 
the purpose of electronic certification of inspection  should be identified . In addition , 
rules should be laid down to ensure that TRACES guarantees  the authenticity, 
integrity and legibility over time of the information and the associated metadata 
throughout the period for whic h they are required to be kept.  
(13) Provision should also be made for an effective and efficient exchange of information 
between Member States' authorities in cases of irregularities detected , in particular  
where products are labelled as organic, but are not accompanied by a certificate of 
inspection.  
(14) As the last import authorisations issued by Member States expired on 30 June 2015 , 
any reference to import authorisations should be deleted from Regulation (EC) No 
1235/2008.  
(15) Operators and Member States should have time to adapt their procedures to the 
electronic certificate of inspection  provided by TRACES . Therefore  it is necessary to  
provide for  a transitional period in which  the issu e and endorsement of the certificate 
of inspection in paper form is still possible . EN 5   EN (16) For the sake of ensuring the proper functioning of the electronic certificate of 
inspection, and in particular to clarif y that in -conversion products are excluded from 
the recognitions  granted to third countries , to harmonise the wording regarding the 
origin of products coming from recognised third countries and to change product 
category C  to cover algae, including micro -algae, it is appropriate to amend  certain 
elements of Annexes III and IV  to Regulation (EC) No 1235/2008  without changing 
the scope of the recognitions previously granted to third countries or to control bodies  
and control authorities .  
(17) According to the information provided by the United States, the treatment with 
antibiotics of apples and pears to control fire blight is not allowed in that third country  
since October 2014. Therefore , it is justified  to remove  the relevant limitation for 
product ca tegories A and D from Annex III to Regulation (EC) No 1235/2008 . 
(18) In the light of the experience gained with the implementation of the equivalence 
system, it is necessary to adapt  the model of the certificate of inspection and extracts 
thereof as set out in Annex es V and VI to Regulation (EC) No 1235/2008 , in order to 
provide information on the producer or processor of the product, as well as on the 
relevant country of origin, when  different  from the country of export  of the product . 
(19) Commission Regulation (EC) No 889/200 86 days down detailed rules relating to 
organic production, labelling and control . 
(20) As the new definitions of ‘processed ’ and ‘unprocessed ’ inserted in Regulation (EC) 
No 1235/2008  would imply  that s ome of the operations included i n the definition of 
preparation  in Article 2( i) of Regulation (EC) No 834/2007 are not to be considered as 
entail ing processing, the rules set out in Article 26 of Regulation (EC) No 889/2008 
for the production of processed food and feed  would become uncle ar. Therefore,  the 
rules on the precautionary measures to be taken to avoid the risk of contamination by 
unauthorised substances or products or mixtures or exchanges with non -organic 
products  should be reworded to make clear that they apply, as appropriate , to operators 
carry ing out preserving activities.  For that purpose, it is also appropriate to i nclude 
definitions of the terms  ‘preserving ’ and ‘process ing’. 
(21) The transmission of information on imported consignments in accord ance with 
Regulation (EC) No 889/2008 should also be done through TRACES.  
(22) A proper functioning of the electronic certification system requires that the 
information to be notified  by the Member States to the Commission on the competent 
authorities  and control bodie s or control authorities include s e-mails addresses and 
Internet websites . It is appropriate to set  a new ultimate date for the notification of that 
information.  
(23) Regulation s (EC) No 1235/2008  and (EC) No 889/2008  should therefore be amended 
accordingly . 
(24) In order to ensure a smooth transition to the new electronic certification  system , this 
Regulation should apply from a date which is six months after its publication. 
However, the amendment of  product category C to cover algae, including micro -algae, 
should apply from the date of application of the relevant provision of Commission 
                                                 
6 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic produ ction and labelling of 
organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).  EN 6   EN Implementing Regulation (EU) 2016/6737 amending Regulation (EC) No 889/2008 to 
allow the use of micro -algae for  food. 
(25) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee on organic production,  
HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment of Regulation (EC) No 1235/2008  
(1) Article 2 is amended as follows:  
(a) points 5 and 6 are  replaced by the following:  
‘5. ‘verification of the consignment’ means the verification carried out by 
the relevant Member State’s competent authority, in the framework of the 
official controls provided for  in Regulation (EC) No 882/2004  of the 
European P arliament and of the Council* , of the fulfilment of the 
requirements of Regulation (EC) No 834/2007, of Regulation (EC) No 
889/2008 and of this Regulation through systematic documentary checks, 
random identity checks and, as appropriate  according to its ri sk 
assessment , physical checks, prior to the release of the consignment for 
free circulation into the Union in accordance with  Article 13 of this 
Regulation;  
6. ‘relevant Member State' s competent authorit y’: means the customs 
authorit y, food safety authorit y or other authorities designated by the 
Member States pursuant to Article 27(1) of Regulation (EC) No 
834/2007 responsible for the verification of the consignments and the 
endorsement of the certificates of inspection;  
*  Regulation (EC) No 882/20 04 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 rules (OJ L 165, 30.4.2004, p.  1).’; 
(b) the following points 8  to 11 are added:  
‘8. ‘aquaculture products’ means aquaculture products as defined in point 34 
of Article 4(1) of Regulation (EU) No 1380/2013 of the European 
Parliament and of the Council *; 
 9. ‘unprocessed’ means unprocessed as used in the definition of 
unprocessed products in point (n) of Article 2(1) of Regulation (EC) No 
852/2004 of the European Parliament and of the Council **, irrespective 
of packaging or labelling operations ; 
                                                 
7  Commission Implementing Regulation (EU) 2016/673 of 29 April 2016 amending Regulation (EC) No 
889/2008 laying down detailed rul es for the implementation of Council Regulation (EC) No 834/2007 
on organic production and labelling of organic products with regard to organic production, labelling and 
control (OJ L 116, 30.4.2016, p. 8).  EN 7   EN 10. ‘processed’  means processed as used in the definition of processed 
produc ts in point (o) of Article 2(1) of Regulation (EC) No 852/2004 , 
irrespective of packaging or labelling operations ; 
11. ‘point of entry’ means the point of release for free circulation . 
* Regulation (EU) No 1380/2013 of the European Parliament and of the 
Council of 11 December 2013 on the Common Fisheries Policy, 
amending Council Regulations (EC) No 1954/2003 and (EC) No 
1224/2009 and repealing Council Regulations (EC) No 2371/2002 and 
(EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 
28.12.2013, p. 22).  
 ** Regulation (EC) No 852/2004 of the European Parliament and of the 
Council of 29 April 2004 on the hygiene of foodstuffs  (OJ L 139, 
30.4.2004, p. 1 ).’ 
(2) In Article 4, paragraph 1 is replaced by the following : 
‘1. The Commission shall consider whether to recognise and include a control 
body or control authority in the list provided for in Article 3 upon receipt of a 
request thereto from the representative of the control body or control authority 
concerned on the basis of the model of application  made available by the 
Commission in accordance with Article 17(2). Only complete requests that 
have been received before 31 October 2017 shall be taken into account for the 
drawing up of the first list.’  
(3) In Article 7 (2), points (e) and (f) are replaced by  the following : 
 ‘(e) the name, address, e -mail address , Internet address and code number of the 
control authority or authorities and the control body or bodies recognised by 
the competent authority referred to in point (d) to carry out controls;  
 (f) the name, address, e -mail address , Internet address and code number of the 
authority or authorities and the control body or bodies responsible in the third 
country for issuing certificates with a view to importing into the Union;’  
(4) In Article 9 (1), point (a)  is replaced by the following:  
‘(a) if, after a third country has been included in the list, any changes are made to 
the measures in force in the third country or their implementation and in 
particular to its control system, that third country shall notify th e Commission 
thereof without delay; any changes made to the information referred to in 
points (d), (e) and (f) of Article 7(2) shall be notified to the Commission 
without delay via the computer system referred to in Article 94(1) of 
Regulation (EC) No 889/ 2008;’  
(5) In Article 10, paragraph 3 is replaced by the following:  
'3. By way of derogation from paragraph 2(b), those products originating from a 
recognised third country listed in accordance with Article 7 , but not covered by 
the recognition granted to that third country , may be included in the list 
provided for in this Article.'  
(6) Article 13 is replaced by the following:  
‘Article 13  
Certificate of inspection  EN 8   EN 1. The release for free circulation in the Union of  a consignment of products 
referred to in Article 1(2) of Regulation (EC) No 834/2007 and imported in 
accordance with Article 33 of that Regulation shall be conditional o n: 
 (a) the submission of an original  certificate of inspection to the relevant 
Member State’s competent authority;  
 (b) the verification of the consignment and the endorsement of the certificate 
of inspection  by the relevant Member State's competent authority ; and 
(c) the indication of the number of the certificate of i nspection in the 
customs declaration for release for free circulation as referred to in 
Article 158(1) of Regulation (EU) No 952/2013  of the European 
Parliament and of the Council* . 
 The verification of the consignment and the endorsement of the certificat e of 
inspection shall be carried out by the relevant Member State's competent 
authority in that Member State where  the consignment is released for free 
circulation in the Union.  
 Member States shall designate the points of entry in their territory and info rm 
the Commission  of the designated points of entry . 
2. The certificate of inspection shall be issued by the relevant control authority or 
control body, endorsed by the relevant Member State's competent authority and 
completed by the first consignee  on the  basis of the model and the notes set out 
in Annex V  and using  the electronic Trade Control and Expert System 
(TRACES) established by Commission Decision 2003/24/EC **.  
The original certificate of inspection shall be  a printed and hand -signed copy of 
the completed electronic certificate in TRACES or, alternatively, a certificate 
of inspection signed  in TRACES  with an advanced electronic signature within 
the meaning of Article 3(11) of Regulation (EU) 910/2014  of the E uropean 
Parliament and of the Council *** or with an electronic signature offering 
equivalent assurances with regard to the functionalities attributed to a signature 
by applying the same rules and conditions as th ose laid down  in the 
Commission’s provisions  on electronic and digitised documents, set out in the 
Annex to  Commissio n Decision 2004/563/EC, Euratom **** . 
When the original certificate of inspection is a printed and hand -signed copy of 
the completed electronic certificate in TRACES , control authoriti es, control 
bodies, relevant Member State's competent authorities and the first consignee 
shall verify a t each stage of issuing, endorsement and reception of the 
certificate of inspection that  this copy corresponds to the information indicated 
in TRACES.  
3. To be accepted  for endorsement , the certificate of inspection shall  have been 
issued by the control authority or control body of the producer  or the processor 
of the product concerned or , where  the operator carrying out  the last operation  
for the purpos es of preparation  is different from the producer or processor of 
the product, by the control authority or control body of the operator carrying 
out the last operation for the purposes of preparation as defined in Article 2(i) 
of Regulation (EC) No 834/2007 . 
That control authority or control body shall  be: EN 9   EN (a)  a control authority or control body listed in Annex III to this Regulation 
for the products concerned and for the third country in which the 
products have their origin, or, where  applicable, in which the last 
operation for the purposes of preparation has been carried out; or   
(b)  a control authority or control body listed in Annex IV to this Regulation 
for the products concerned and for the third country in which the 
products hav e their origin or in which the last operation for the purposes 
of preparation has been carried out.  
4. The control authority or control body issuing the certificate of inspection shall 
only issue the certificate of inspection and sign the declaration in bo x 18 of the 
certificate after it has carried out a documentary check on the basis of all 
relevant inspection documents, including in particular the production plan for 
the product concerned, transport docume nts and commercial documents  and, as 
appropriate according to its risk assessment , it has carried out a physical check 
of the consignment . 
 However, f or processed product s, if the  control authorit y or control body 
issuing the certificate of inspection is a control authority or control body listed 
in Anne x III , it shall only issue the certificate of inspection and sign the 
declarati on in box 18 of the certificate  after it has verified that all organic 
ingredients of the product have been controlled and certified by a control 
authority or control  body  recognised by the third country  concerned listed in 
that Annex , or if the  issuing control authority or control body is a control  
authorit y or control  body listed in Annex IV , it shall only issue the certificate 
of inspection and sign the declaration in bo x 18 of the certificate after it has 
verified that all organic ingredients of such products have been controlled and  
certified by a control authority or control body listed in Annex III or IV or have 
been produced and certified in the Union in accordance w ith Regulation  (EC) 
No 834/2007 . 
 Where  the operator carrying out  the last operation for the purposes of 
preparation is different from the producer or processor of the product, the 
control authority or control body issuing the certificate of inspection and listed 
in Annex IV  shall only issue the certificate of inspection and sign the 
declarati on in box 18 of the certificate  after it has carried out a documentary 
check on the basis of all relevant inspection documents, including transport 
documents and commercial documents, it has verified that the production or 
the processing of the product concerned has been controlled and  certified by a 
control body or control authority recognised for the products concerned and the 
country concerned in accordance with Article 33(3) of Regulation (EC) No 
834/2007 and it has carried out, as appropriate according to its risk assessment , 
a physical check  of the consignment.  
 At the request of the Commission or of the competent authority of a Member 
State, t he control authority or control body issuing the certificate of inspection 
in accordance with the second and third subparagraphs  shall make available 
without delay the list of all operators in the organic production chain and the 
control authorities or control bodies under whose control those operators have 
placed their operations.   
5. The certificate of inspection shall be made in one single original.  EN 10   EN The first consignee or, where relevant, the importer may make a copy of the 
certificate of inspection for the purpose of informing the control authorities and 
control bodies in accordance with Article 83 of Regulation (EC ) No 889/2008. 
Any such copy shall carry the indication ‘COPY’ printed or stamped thereon.  
6. At the verification of a consignment, the relevant Member State’s competent 
authority  shall endorse the original certificate of inspection in box 2 0 and shall 
return it to the person who submitted the certificate .  
7. The first consignee shall, at the reception of the consignment, complete box 2 1 
of the certificate of inspection, to certify that the reception of the consignment 
has been carried out in accordance with Article 34 of Regulation (EC) No  
889/2008.  
The first consignee shall then send the original of the certificate to the importer 
mentioned in box 11 of the certificate for the purpose s of the second 
subparagraph of Article 33(1) of Regulation (EC) No 834/2007.  
* Regulation (EU) No 952/2013  of the European Parliament and of the Council 
of 9 October 2013 laying down the Union Customs Code (OJ L 269, 
10.10.2013, p. 1).  
** Commission Decision 2003/24/EC of 30 December 2002 concerning the 
development of an integrated computerised veterinary syst em (OJ L 8, 
14.1.2003, p. 44).  
*** Regulation (EU) No 910/2014 of the European Parliament and of the 
Council of 23 July 2014 on electronic identification and trust services for 
electronic transactions in the internal market and repealing Directive 
1999/93/ EC (OJ L 257, 28.8.2014, p. 73).  
**** Commission Decision 2004/563/EC, Euratom of 7 July 2004 amending 
its Rules of Procedure (OJ L 251, 27.7.2004, p. 9). ’ 
(7) The following Articles 13a to 13 d are inserted : 
‘Article 13a  
Force majeure or exceptional circumstan ces 
1. In cases of force majeure  or exceptional circumstances preventing the 
electronic system from working, and in particular of malfunctioning of the 
system or a lack of a lasting connection, certificates of inspec tion and their 
extracts may be issued and endorsed pursuant to Article 13 (3) to (7)  without 
using TRACES in accordance with paragraphs 2 , 3 and  4 of this  Article, and on 
the basis of the model s and the notes set out in Annex V  or VI. The competent 
authorities, control authorities , control bodies and operators shall inform the 
Commission without delay and shall insert in TRACES all the necessary 
details within ten calendar days following the re -establishment of the system.  
2. When the certificate of inspection is issued without usi ng TRACES, it shall be 
drawn up in one of the official languages of the Union and filled in, except for 
the stamps and signatures, either entirely in capital letters or entirely in 
typescript.  EN 11   EN The certificate of inspection shall be in the official language  or one of the 
official languages of the Member State of clearance . Where necessary, the 
relevant Member State's competent authorities may request a translation of the 
certificate of inspection into its official la nguage or one of its official 
languages.  
Uncertified alterations or erasures shall invalidate the certificate.  
3. The control authority or control body issuing the certificate of inspection shall 
give a serial number to each issued certificate and keep a register of the issued  
certificates in chro nological order  and make the correspondence afterward with 
the serial number given by TRACES . 
4. Whe re the certificate of inspection is issued and endorsed without using 
TRACES, the second and third subparagraph s of Article 15(1) and Article 
15(5) shall no t apply.   
 Article 13 b 
Importer  
The importer shall i ndicate the  number of the certificate of inspection  in the customs 
declaration for release for free circulation as referred to in Article 158(1) of Regulation (EU) 
No 952/2013 . 
 Article 13 c 
Access rights  
The Commission shall be in charge of  granting and updating access rights to TRACES  of the 
competent authorities as defined  in Article 2(n) of Regulation (EC) No 834/2007 , of 
competent authorities of third countries recognised in accordance with Article 33( 2) of that 
Regulation and of control authorities and control bodies listed in Ann ex III or IV to this 
Regulation . Before granting access rights to TRACES , the Commission shall verify the 
identity of the competent authorities, control authorities and contro l bodies  concerned.  
The competent authorities as defined  in Article 2(n) of Regulation (EC) No 834/2007 shall be 
in charge of  granting and updating access rights to TRACES of operators , control authorities 
and control bodies in the Union.  Before granting access rights to TRACES , the competent 
authorities shall verify the identity of the operators, control authorities and control bodies  
concerned. Member States shall designate a single authority responsible to coordinate the 
cooperation and the contacts wit h the Commission  in this area.  
The competent authorities shall communicate the granted  access rights  to the Commission . 
The Commission shall activate those access rights  in TRACES . 
 Article 13 d 
Integrity and legibility of information  
TRACES  shall protect t he integrity of the information encoded  in accordance with this 
Regulation . 
In particular, it shall offer the following guarantees:  EN 12   EN (a) it shall allow each user to be unequivocally identified and shall incorporate effective 
control measures of access rights in  order to protect against illegal, malicious or 
unauthorised access, deletion, alteration or movement of the information, files and 
metadata;  
(b) it shall be equipped with physical protection systems against intrusions and 
environmental incidents and software protection against cyber -attacks;  
(c) it shall safeguard stored data in an environment which is secure in both physical and 
software terms;  
(d) it shall prevent, by various means, any unauthorised changes and incorporate 
integrity mechanisms to check if the inform ation has been altered over time;  
(e) it shall keep an audit trail for each es sential stage of the procedure;  
(f) it shall provide reliable format conversion and migration procedures in order to 
guarantee that the information is legible and accessible throughout t he entire storage 
period required;  
(g) it shall have sufficiently detailed and up -to-date functional and technical 
documentation on the operation and characteristics of the system, that documentation 
being accessible at all times to the organisational entities  responsible for the 
functional and/or technical specifications.  ’ 
(8)  Article 14 is amended as follows:  
(a) Paragraph 1 is replaced by the following:  
‘1. Where a consignment coming from a third country is placed under  
customs warehousing or inward processing as provided for in Regulation 
(EU) No 952/2013 , and subject to one or more preparations as referred to 
in the second subparagraph, the relevant Member State's competent 
authority shall carry out the verification of the consignment  as referred to 
in point ( b) of the first subparagraph of Article 13(1) of this Regulation 
before the first preparation is carried out. The reference number of the 
customs declaration by which the goods have been declared for customs 
warehousing or for inward processing procedure s hall be indicated in box 
19 of the certificate of inspection.  
The preparation shall be limited to the following types of operations:  
(a) packaging or repackaging; or  
(b) labelling concerning the presentation of the organic production 
method.  
After this preparation, the consignment shall be subject, before the 
release for free circulation, to the measures referred to in Article 13(1) of 
this Regulation.  
After this procedure, the original of the certificate of inspection shall, 
where relevant, be returned to the importer of the consignment, referred 
to in box 11 of the certificate for the purposes of  the second subparagraph 
of Article 33(1) of Regulation (EC) No 834/2007.’  
(b) Paragraph 2 is amended as follows:  
(i) the second subparagraph is replace d by the following:  EN 13   EN ‘For each of the batches which results from the splitting, the importer 
mentioned in box 11 of the certificate of inspection shall submit an 
extract of the certificate of inspection through TRACES  to the relevant 
Member State’s competen t authority , in accordance with the model and 
the notes set out in Annex VI. After verification of the batch, the relevant 
Member State's competent authority shall endorse the extract of the 
certificate of inspection in box 1 3 for the purpose of the releas e for free 
circulation . The verification of the batch and the endorsement of the 
extract of the certificate of inspection shall be carried out by the relevant 
Member State's competent authority  in that Member State where the 
batch  is released for free  circulation in the Union. ’; 
(ii) the fourth subparagraph is deleted.  
(9) Article 15 is amended as follows:  
(a) in paragraph 1, the following  second and third subparagraph s are added:  
‘When the verification of a consignment by a relevant Member State's 
competent a uthority leads to the detection of an infringement or an 
irregularity that leads to the refusal of the endorsement of the certificate 
and of the release for free circulation of products, that authority shall 
without delay notify that infringement or irregu larity to the Commission 
and to the other Member States through  TRACES.  
Member States shall ensure effective and efficient coordination amongst 
competent authorities performing official controls with a view to 
exchang ing without delay information on the de tection of consignments 
of products referred to in Article 1(2) of Regulation (EC) No 834/2007 
bearing terms referring to the organic production method , but not 
declared as intended to be imported in accordance with Regulation (EC) 
No 834/2007. The r elevan t Member State 's competent authorit y shall 
without delay notify the Commission and the other Member States of 
those findings through TRACES .’ 
(b) the following  paragraph 5 is added:  
‘5. The importer, the first consignee or their control authority or control 
body shall send the information on infringements or irregularities as 
regards imported products to the competent authorities of the Member 
States concerned via the computer system refe rred to in Article 94(1) of 
Regulation (EC) No 889/2008  through TRACE S.’ 
(10) In Article 17, paragraph 3 is replaced by the following : 
‘3. The computer system provided for in paragraph 1 shall be able to collect the 
requests, documents and information referred to in this Regulation where 
appropriate.’  
(11) In Article 18, the second paragraph is replaced by the following:  
‘The first list of recognised countries shall include Argentina, Australia, Costa Rica, 
India, Israel*, New Zealand and Switzerland. It shall not co ntain the code 
numbers referred to in Article 7(2)(f) of this Regulation. These code numbers 
shall be added before 1 July 2010 by updating the list in accordance with 
Article 17(2).  EN 14   EN * Hereafter understood as the State of Israel, excluding the territories u nder Israeli 
administration since June 1967, namely the Golan Heights, the Gaza Strip, East 
Jerusalem and the rest of the West Bank .’ 
(12) Article 19 is deleted.  
(13) The following  Article 19a is inserted : 
‘Transitional rules on the use of certificates of inspection  not issued in TRACES  
Until [ 6 months after the date of application of this amending Regulation ] certificates of 
inspection as referred to in Article 13(1)(a)  and their extracts  as referred to in Article 14(2) 
may be issued and endorsed pursuant to Article  13(3) to (7)  without using TRACES  in 
accordance with  Article 13a (1), (2) and (3)  and on the basis of the model s and the notes set 
out in Annex V  or VI.’ 
(14) Annex III is amended in accordance with Annex I to this Regulation.  
(15) In Annex IV , in the list of produc t categories, ‘C:  Aquaculture products and 
seaweeds’ is replaced by ‘C: Unprocessed aquaculture products  and algae ’. 
(16) Annex V is replaced by  the text set out in Annex I I to this Regulation . 
(17) Annex VI is replaced by the text set out in Annex II I to this Regulatio n. 
Article 2  
Amendment of Regulation (EC) No 889/2008  
(1) In Article 2, the following points are added:  
 ‘(t) ‘preserving ’ means any action, different from farming and harvesting, that is 
carried out on products, but which does not qualify as  processing as defined in 
point (u), including all actions referred to in point (n) of  Article 2(1) of 
Regulation (EC) No 852/2004 of the European Parliament and of the Council * 
and excluding packagi ng or labelling of the product;  
(u) ‘processing ’ means an y action referred to in point (m) of Article 2(1) of 
Regulation (EC) No 852/2004 , including the use of substances referred to in 
Article 19(2)(b) of Regulation (EC) No 834/2007. Packaging or labelling 
operations shall not be considered as processing.  
*  Regulation (EC) No 852/2004 of the European Parliament and of the Council 
of 29 April 2004 on the hygiene of foodstuffs  (OJ L 139, 30.4.2004, p. 1 ).’  
(2) The title of Title II is replaced by the following: ‘RULES ON PRODUCTION, 
PRESERVATION, PROCESSING, PACKAGI NG, TRANSPORT AND 
STORAGE OF ORGANIC PRODUCTS ’  
(3) The title of Chapter 3 of Title II is replaced by the following: ‘Preserved and 
processed products ’ 
(4) Article 26   is replaced by the following:  EN 15   EN ‘Article 26   
Rules for preserving  products and for the production of processed feed and food  
1. Operators preserving products or producing processed feed or food shall establish 
and update appropriate procedures based on a systematic identification of critical 
processing steps.  
 The application of th ose proce dures  shall guarantee at all times that preserved or 
processed products comply with the organic production rules.   
2. Operators shall comply with and implement the proce dures referred to in paragraph 
1. In particular, operators shall:  
(a) take prec autionary measures to avoid the risk of contamination by unauthorised 
substances or products;  
(b) implement suitable cleaning measures, monitor their effectiveness and record 
those measures ; 
(c) guarantee that non -organic products are not placed on the mar ket with an 
indication referring to the organic production method.  
 3. Where  non-organic products are also prepared or stored in the preparation unit 
concerned, the operator shall:  
(a) carry  out the operations continuously until the complete run has been dealt 
with, separated by place or time from similar operations carried out  on non -
organic products;  
(b) store organic products, before and after the operations, separate by place or 
time fro m non -organic products;  
(c) inform the control authority or control body of the operations referred to in 
points (a) and (b)and  keep available an updated register of all operations and 
quantities processed;  
(d) take the necessary measures to ensure identif ication of lots and to avoid 
mixtures or exchanges with non -organic products;  
(e)  carry out operations on organic products only after suitable cleaning of the 
production equipment.  
4. Additives, processing aids and other substances and ingredients used f or processing 
feed or f ood and any processing practice applied, such as smoking, shall respect the 
principles of good manufacturing practice. ’ 
(5) In Article 84, the following  third paragraph is added:  
‘The importer shall transmit the information referred to in the first and second 
paragraphs by using the electronic Trade Control and Expert System (TRACES) 
established by Commission Decision 2003/24/EC *. 
* Commission Decision 2003/24/EC of 30 December 2002  concerning the 
development of an integrated computerised veterinary system (OJ L 8, 14.1.2003, p. 
44).’ 
(6) Article 94(1) is amended as follows:  
(a) points (a) and (b) are replaced by the following:  EN 16   EN ‘(a) by 30 June 2017, the information referred to in Article 35( a) of 
Regulation (EC) No 834/2007, including e -mail address and Internet 
address, and afterwards any changes thereto ;  
(b) by 30 June 2017, the information referred to in Article 35(b) of 
Regulation (EC) No 834/2007 , including address, e -mail address and 
Internet address, and afterwards any changes thereto ; ’; 
(b) the following point (e) is added:  
‘(e) by 30 June 2017, the name, address, e -mail address and Internet address 
of the relevant Member State's competent authorities as defined  in point 
(6) of Article 2  of Regulation (EC) No 1235/2008 , and afterwards any 
changes thereto .’ 
Article 3  
This Regulation shall enter into force on the seventh  day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from [a date to be inserted which corresponds to 6 months following the date of 
publication of the Regulation].  However, point (2) of Article 1 shall apply from the date of 
entry into force of this Regulation and point ( 15) of Article 1 shall apply from 7 May 2017.  
This Regu lation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
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