title: COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2019/1715 as regards procedures for the establishment and use of ADIS and EUROPHYT, the issuance of electronic animal health certificates, official certificates, animal health/official certificates and commercial documents, the use of electronic signatures, and the functioning of TRACES, and repealing Decision 97/152/EC

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 29.3.2021

               amending Implementing Regulation (EU) 2019/1715 as regards procedures for the establishment and use of ADIS and EUROPHYT, the issuance of electronic animal health certificates, official certificates, animal health/official certificates and commercial documents, the use of electronic signatures, and the functioning of TRACES, and repealing Decision 97/152/EC

               (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 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 safety
                  1
               , and in particular Article 51 thereof,

               Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health
                  2
                (‘Animal Health Law’), and in particular points (b) to (f) of the first paragraph of Article 23, Article 30(1)(b)(ii) and point (c) of the first paragraph of Article 35 thereof,

               Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC
                  3
               , and in particular points (a), (b) and (c) of the first paragraph of Article 104 thereof,

               Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official 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
                  4
                (Official Controls Regulation), in particular point (a) of the first paragraph of Article 58, point (f) of the first paragraph of Article 90, points (a) and (b) of the first subparagraph of Article 102(6), Article 103(6) and points (a) to (d) and point (g) of the first paragraph of Article 134 thereof,

               Whereas:

               (1)Commission Implementing Regulation (EU) 2019/1715
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                lays down rules for the functioning of the information management system for official controls (IMSOC) and its system components, namely the system implementing the procedures for the Rapid Alert System for Food and Feed and Administrative Assistance and Cooperation (iRASFF), the system for notifying and reporting information on animal diseases (‘ADIS’), the system for notifying official confirmation of the presence of pests in plants and plant products on Member States’ territory (EUROPHYT) and the Trade Control and Expert System for exchanging data, information and documents (TRACES). It also lays down rules on the necessary links between those components.

               (2)It also lays down rules for the establishment of the network for the functioning of ADIS and the listing of notification and reporting regions for the purpose of Union notification and Union reporting of animal diseases.

               (3)In order to ensure uniform use of ADIS by Member States, Commission Implementing Regulation (EU) 2020/2002
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                lays down rules concerning the format and structure of the data for Union notifications and Union reporting of diseases to be entered into that system, the format and procedure for the reporting as well as the deadlines and frequencies of the notifications and reporting.

               (4)Common rules for the ADIS network contact points should be included in Implementing Regulation (EU) 2019/1715 with respect to the submission of Union notifications and Union reporting in accordance with Implementing Regulation (EU) 2020/2002. In order to comply with Union data protection rules, those rules should also include provisions on the maximum storage period of personal data in ADIS.

               (5)This Regulation should also lay down rules, to be included in Implementing Regulation (EU) 2019/1715, with respect to the links that are necessary between ADIS and TRACES in view of ensuring that relevant data concerning Union notifications is automatically exchanged or made available in both systems, and providing relevant information to network members.

               (6)Implementing Regulation (EU) 2019/1715 lays down rules on the use of TRACES for the submission to the EUROPHYT interception network of interception notifications of consignments of plants, plant products and other objects from other Member States or third countries that may present an imminent danger of introducing or spreading pests. It provides that interception notifications of consignments traded in the Union are to be submitted by the EUROPHYT interception network contact point, while interception notifications of consignments entering the Union are to be submitted by the official plant health officer taking the decision on those consignments.

               (7)Given that notifications of intercepted consignments of plants, plant products and other objects traded in the Union fall within the scope of the notifications of non-compliance of goods covered by Regulation (EU) 2017/625 and are to be exchanged in iRASFF between alert and cooperation network contact points, notifications of those intercepted consignments should be made in iRASFF.

               (8)In order to further ensure that iRASFF is also used to exchange notifications of non-compliant consignments of plants, plant products and other objects traded in the Union that may pose a risk to plant health, it is appropriate to rephrase the definition of the term ‘non-compliance notification’ laid down in Implementing Regulation (EU) 2019/1715.

               (9)In parallel, in order to avoid confusion about the meaning of the term ‘risk’ defined in Implementing Regulation (EU) 2019/1715, it is also necessary to delete that definition, adapt instead certain definitions of notifications in iRASFF and clarify in those definitions the different categories of risk.

               (10)Similarly, in order to avoid confusion about the meaning of the defined terms ‘food fraud network’ and ‘food fraud notification’ in Implementing Regulation (EU) 2019/1715 and better reflect the scope of Regulation (EU) 2017/625 in these defined terms, it is necessary to rename these defined terms respectively ‘fraud network’ and ‘fraud notification’ and adjust all provisions in Implementing Regulation (EU) 2019/1715 related to food fraud accordingly.

               (11)Implementing Regulation (EU) 2019/1715 also provides that the information on intercepted consignments entering the Union is to include the information recorded in the common health entry document (CHED) by the official plant health officer in accordance with Article 55(2) and Article 56 of Regulation (EU) 2017/625, additional information on the measures taken concerning the intercepted consignments and information regarding the quarantine imposed.

               (12)Since the CHED contains entries for recording information on the measures taken concerning intercepted consignments, including cases where a quarantine is imposed, it is not necessary to submit an interception notification containing the same information also in TRACES. Therefore, the obligation to submit an interception notification containing that same information in TRACES should be lifted and be replaced by the obligation to record the interception data in the CHED.

               (13)Moreover, since any non-compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625 concerning consignments entering the Union or traded in the Union is to be notified either in TRACES or in iRASFF, all provisions related to EUROPHYT interception notifications should be deleted from Implementing Regulation (EU) 2019/1715.

               (14)Implementing Regulation (EU) 2019/1715 lays down rules for the use of electronic CHEDs and the issuance of electronic certificates for consignments of animals and goods entering the Union. Those rules include high assurance levels related to certifying officers’ identity proofing prior to granting electronic signature capability and the application of a qualified electronic timestamp to the electronic signature generated by a trusted third party.

               (15)Experience has shown that those high assurance levels are not necessary since the authentication mechanism prior to login in TRACES, a Member State’s national system, a third country’s or an international organisation’s electronic certification system provides a sufficient degree of assurance of the signatory’s claimed identity. In addition, timestamping is not necessary. The secure flow of data within and between systems and the application of a qualified electronic seal designed to reliably prove correct timing, integrity and correctness of data provide sufficient guarantees that any subsequent alteration of the data is detectable.

               (16)This Regulation should therefore introduce amendments to Implementing Regulation (EU) 2019/1715 that allow official veterinarians, official plant health officers and certifying officers to use electronic signatures in electronic CHEDs and certificates with lower identity assurance levels and without recording timestamps, in line with Regulation (EU) No 910/2014 of the European Parliament and of the Council
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               .

               (17)This Regulation should also include amendments to the rules in Implementing Regulation (EU) 2019/1715 with regard to the issuance of electronic certificates or commercial documents accompanying consignments of animals and certain goods moved between Member States pursuant to Article 150, Article 161(5), Article 167(4), Article 217 and Article 223(5) of Regulation (EU) 2016/429, consignments of certain animal by-products and derived products not intended for human consumption and transported within the Union pursuant to Article 17 of Commission Regulation (EU) No 142/2011
                  8
               , and consignments of plants, plant products and other objects exported or re-exported from the Union pursuant to Articles 100(5) and 101(6) of Regulation (EU) 2016/2031. Those rules should be similar to the rules for the issuance of electronic certificates for consignments of animals and goods entering the Union.

               (18)As Regulation (EU) 2016/2031 provides that electronic phytosanitary certificates for export or re-export from the Union territory of plants, plant products and other objects are to be provided only through, or in electronic exchange with the IMSOC, this Regulation should provide for the incorporation in Implementing Regulation (EU) 2019/1715 of rules for the issuance of such certificates in line with that Regulation.

               (19)With the aim of strengthening enforcement of Union rules, Implementing Regulation (EU) 2019/1715 provides that the TRACES network contact points are to maintain and keep up to date in TRACES lists of certain reference data necessary for the good functioning of TRACES. The lists include food business establishments approved in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council
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                and establishments, plants and operators handling animal by-products or derived products, approved or registered in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council
                  10
               .

               (20)To the same end, this Regulation should extend further those lists of reference data to include registered and approved establishments and operators referred to in Regulation (EU) 2016/429 as well as certain professional operators registered pursuant to Regulation (EU) 2016/2031, in so far as they are involved in cross-border activities.

               (21)In view of providing support for the preparation of Member States’ risk analyses for inspections or audits regarding the transport of live animals, the lists of reference data should also include control posts approved pursuant to Council Regulation (EC) No 1255/97
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               , as well as authorised transporters, certified drivers and attendants, and approved means of transport pursuant to Council Regulation (EC) No 1/2005
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               .

               (22)As Regulation (EU) 2016/429 applies from 21 April 2021, the amendments concerning ADIS, the necessary links between ADIS and TRACES, and the extension of the lists of reference data to include registered and approved establishments and operators pursuant to Regulation (EU) 2016/429 should also apply from 21 April 2021.

               (23)Considering the importance of reference data for the good functioning of TRACES, the extension of the lists of reference data from Regulations (EC) No 1255/97, (EC) No 1/2005 and (EU) 2016/2031 should also apply from 21 April 2021.

               (24)Considering that it is necessary to further develop the iRASFF and TRACES systems with respect to notifications of interceptions, the date of application of the amendments to Section 3 of Chapter 3 of Implementing Regulation (EU) 2019/1715 should be deferred until 1 December 2021.

               (25)The Annex to Commission Decision 97/152/EC
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                sets out the information to be entered in the TRACES system of consignments of animals or animal products from third countries. That Decision is based on Article 12 of Council Decision 92/438/EEC
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               , which was repealed by Article 146(1) of Regulation (EU) 2017/625 with effect from 14 December 2019. The information set out in the Annex to Decision 97/152/EC is now included in the CHED-A and the CHED-P in Sections A and B of Part 2 of Annex II to Implementing Regulation (EU) 2019/1715. For the sake of clarity and consistency, Decision 97/152/EC should therefore be repealed.

               (26)The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council
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                and delivered an opinion on 14 January 2021.

               (27)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

               Amendments

               Implementing Regulation (EU) 2019/1715 is amended as follows:

               1.in Chapter 1, Article 2 is amended as follows:

               (a)point (8) is deleted;

               (b)point (9) is replaced by the following:

               ‘(9)
                     “RASFF network” means the Rapid alert system established as a network by Article 50 of Regulation (EC) No 178/2002 for the notifications referred to in points (15) to (20) of this Article;’;

               (c)point (11) is replaced by the following:

               ‘(11)
                     “fraud network” means the network composed of the Commission, Europol and the liaison bodies designated by the Member States in accordance with Article 103(1) of Regulation (EU) 2017/625 for the specific purpose of facilitating the exchange of information on fraud notifications as defined in point (21);’;

               (d)point (12) is replaced by the following:

               ‘(12)
                     “alert and cooperation network” means a network composed of the RASFF, AAC and fraud networks;’;

               (e)point (14) is replaced by the following:

               ‘(14)
                     “non-compliance notification” means a notification in iRASFF of a non-compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625 that does not represent a risk within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005;’;

               (f)point (20) is replaced by the following:

               ‘(20)
                     “border rejection notification” means a notification in iRASFF of a rejection of a batch, container or cargo of food, food contact material or feed due to a risk as referred to in point (c) of the first subparagraph of Article 50(3) of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005;’;

               (g)point (21) is replaced by the following:

               ‘(21)
                     “fraud notification” means a non-compliance notification in iRASFF concerning suspected intentional action by businesses or individuals for the purpose of deceiving purchasers and gaining undue advantage therefrom, in violation of the rules referred to in Article 1(2) of Regulation (EU) 2017/625;’;

               (h)point (22) is replaced by the following:

               ‘(22)
                     “original notification” means a non-compliance notification, an alert notification, an information notification, a news notification, a fraud notification or a border rejection notification;’;

               (i)points (33) and (34) are deleted;

               2.in Chapter 2, Article 6(2) is amended as follows:

               (a)point (b) is replaced by the following:

               ‘(b)
                     EUROPHYT and TRACES, allowing the exchange of data concerning EUROPHYT outbreak notifications;’;

               (b)point (c) is replaced by the following:

               ‘(c)
                     iRASFF and TRACES, allowing the exchange of data concerning operators’ past records as regards compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625;’;

               (c)the following point is added:

               ‘(d)
                     ADIS and TRACES, allowing the exchange of data and information concerning Union notifications.’;

               3.in Chapter 3, Section 1 is amended as follows:

               (a)Article 12 is replaced by the following:

               ‘Article 12

               Liaison bodies responsible for the exchange of certain types of information

               Member States shall indicate which of the liaison bodies designated in accordance with Article 103(1) of Regulation (EU) 2017/625 are responsible for exchanging information on fraud notifications.’;

               (b)in Article 13, paragraph 2 is replaced by the following:

               ‘2.
                     Member States may include their fraud network contact point in their single contact point.’;

               (c)Article 21 is replaced by the following:

               ‘Article 21

               Fraud notifications

               1.Fraud network contact points shall exchange fraud notifications including at least the following:

               (a)all the information required by Article 16(1);

               (b)a description of the suspected fraudulent practice;

               (c)the identification, where possible, of the operators involved;

               (d)information as to whether there are ongoing police or judicial investigations into the suspected fraudulent practice;

               (e)information on any instructions from the police or judicial authorities as soon as they are available and can be disclosed.

               2.Fraud network contact points shall communicate any information concerning health risks to their RASFF network contact point without undue delay.

               3.The Commission contact point shall verify each fraud notification after it has been exchanged, without undue delay.’;

               (d)in Article 23, paragraph 3 is replaced by the following:

               ‘3.
                     Without prejudice to the Commissions’ right of access pursuant to Article 8(2), only the notifying, notified and requested contact points of the fraud network shall have access to fraud notifications.’;

               (e)in Article 24, paragraph 2 is replaced by the following:

               ‘2.
                     By way of derogation from paragraph 1, verification of non-compliance, fraud and border rejection notifications shall cover points (b), (c) and (e) of that paragraph.’;

               (f)in Article 25(1), point (a) is replaced by the following:

               ‘(a)
                     a notifying contact point to withdraw a non-compliance, fraud or follow-up notification;’;

               (g)in Article 27, paragraph 2 is replaced by the following:

               ‘2.
                     Where a non-compliance or fraud notification concerns a product originating in or distributed to a third country that does not have access to iRASFF or TRACES, the Commission may inform that third country.’;

               (h)in Article 28(1), point (c) is replaced by the following:

               ‘(c)
                     the fraud network contact points shall exchange information on fraud notifications via email;’;

               4.in Chapter 3, Section 2 is replaced by the following:

               ‘Section 2

               ADIS

               Article 29

               ADIS network

               1.Each ADIS network member shall designate at least one contact point responsible for the submission in ADIS of data and information concerning Union notification and Union reporting in accordance with Articles 3, 4, 6, 7, 8, 11 and 13 of Commission Implementing Regulation (EU) 2020/2002*.

               2.Each ADIS network contact point shall maintain and keep up to date in ADIS the list of notification and reporting regions established by its Member State and laid down in Annex IV to Implementing Regulation (EU) 2020/2002.

               Article 29a

               Storage period of personal data

               Personal data from Union notifications and Union reports referred to in Article 29(1) shall be stored in ADIS for no more than 10 years.

               Article 29b

               Contingency arrangements for ADIS

               1.Where ADIS is unavailable, the ADIS network contact points shall submit the data and information concerning Union notifications and Union reports referred to in Article 29(1) via email or by other means specified on the Commission’s website.

               2.Once ADIS becomes available again, the ADIS network contact points shall insert in it the data and information submitted outside the system.

               -----------------------------------

               *Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system (OJ L 412, 8.12.2020, p.1).’;

               5.in Chapter 3, Section 3 is amended as follows:

               (a)Article 30 is replaced by the following:

               ‘Article 30

               EUROPHYT outbreak network

               Each EUROPHYT outbreak network member shall designate a contact point responsible for the submission of EUROPHYT outbreak notifications in EUROPHYT.’;

               (b)Articles 31 and 33 are deleted;

               6.in Chapter 3, Section 4 is amended as follows:

               (a)Article 35 is replaced by the following:

               ‘Article 35

               TRACES network

               Without prejudice to Article 4(2), each TRACES network member shall designate one or more contact points for the functionalities provided for in Article 132(d) and Article 133 of Regulation (EU) 2017/625, and in other Union legislation referring to TRACES.’;

               (b)Article 39 is replaced by the following:

               ‘Article 39

               Issuance of electronic certificates for consignments of animals and goods entering the Union and use of electronic signatures

               1.Electronic animal health certificates, official certificates and animal health/official certificates for consignments of animals and goods entering the Union shall meet all of the following requirements:

               (a)they shall be issued in one of the following systems:

               (i)TRACES;

               (ii)a Member State’s national system;

               (iii)a third country’s or an international organisation’s electronic certification system that is capable of exchanging data with TRACES;

               (iv)a third country’s or an international organisation’s electronic certification system that is capable of exchanging data with a Member State’s national system;

               (b)they shall be signed by an authorised officer with his/her electronic signature;

               (c)they shall bear the advanced or qualified electronic seal of the issuing competent authority, or the advanced or qualified electronic signature of its legal representative.

               2.Where electronic animal health certificates, official certificates and animal health/official certificates are issued in accordance with point (a)(iii) or (iv) of paragraph 1, the electronic signature of the authorised officer is not required.

               3.The Commission shall be notified in advance of the issuance of electronic animal health certificates, official certificates and animal health/official certificates in accordance with point (a)(iv) of paragraph 1.

               4.The competent authority shall accept electronic phytosanitary certificates, as required for the introduction of plants, plant products and other objects into the Union territory in accordance with Section 1 of Chapter VI of Regulation (EU) 2016/2031, only where they are issued in accordance with point (a)(i) or (iii) of paragraph 1 of this Article.’;

               (c)the following articles are inserted after Article 39:

               ‘Article 39a

               Issuance of electronic certificates and commercial documents for movements of animals and goods between Member States and use of electronic signatures

               Electronic animal health certificates, official certificates and animal health/official certificates for movements of animals, products of animal origin and germinal products between Member States, and electronic commercial documents for certain animal by-products and derived products, not intended for human consumption and transported to another Member State, shall meet all of the following requirements:

               (a)they shall be issued in TRACES;

               (b)they shall be signed by an official veterinarian or a certifying officer with his/her electronic signature;

               (c)they shall bear the advanced or qualified electronic seal of the issuing competent authority.

               Article 39b

               Issuance of electronic certificates for export and re-export of plants, plant products and other objects and use of electronic signatures

               Electronic phytosanitary certificates for export or re-export of plants, plant products and other objects from the Union territory to a third country shall be issued in one of the following systems:

               (a)TRACES, provided that the certificate meets all of the following requirements:

               (i)it is signed by a certifying officer with his/her electronic signature;

               (ii)it bears the advanced or qualified electronic seal of the issuing competent authority;

               (b)the national system of a Member State, provided that the certificate meets all of the following requirements:

               (i)it is signed by a certifying officer with his/her electronic signature;

               (ii)it is transmitted to TRACES at the latest at the time of electronic signature by the certifying officer and that transmission is sealed with the advanced or qualified electronic seal of the issuing competent authority.’;

               (d)Article 41 is replaced by the following:

               ‘Article 41

               Use of an electronic CHED

               An operator’s or a competent authority’s use of a CHED in an electronic format shall be by means of one of the following systems:

               (a)TRACES, provided that the CHED meets all of the following requirements:

               (i)it is signed by the operator responsible for the consignment with his/her electronic signature;

               (ii)it is signed by the official veterinarian, the official plant health officer or the certifying officer at border control posts or control points with his/her electronic signature;

               (iii)it bears the advanced or qualified electronic seal of the issuing competent authority;

               (b)the national system of a Member State, provided that the CHED meets all of the following requirements:

               (i)it is signed by the operator responsible for the consignment with his/her electronic signature;

               (ii)it is signed by the official veterinarian, the official plant health officer or the certifying officer at border control posts or control points with his/her electronic signature;

               (iii)it is transmitted to TRACES at the latest at the time when the decision on the consignment is taken on the basis of official controls and that transmission is sealed by the advanced or qualified electronic seal of the issuing competent authority.’;

               (e)in Article 42, paragraph 3 is deleted;

               (f)Article 45 is replaced by the following:

               ‘Article 45

               Lists of reference data

               1.Each TRACES network contact point shall maintain and keep up to date in TRACES lists of the following:

               (a)food business establishments that the competent authority of its Member State has approved in accordance with Article 6(3) of Regulation (EC) No 852/2004;

               (b)establishments, plants and operators handling animal by-products or derived products that the competent authority of its Member State has approved or registered in accordance with Article 47 of Regulation (EC) No 1069/2009;

               (c)control posts to which the competent authority of its Member State has granted an approval in accordance with Article 3 of Council Regulation (EC) No 1255/97*;

               (d)transporters carrying out long journeys to which the competent authority has granted an authorisation pursuant to Article 11(1) of Council Regulation (EC) No 1/2005**;

               (e)establishments included in the register of approved establishments referred to in point (b) of the first subparagraph of paragraph 1 of Article 101 of Regulation (EU) 2016/429 in so far as they move kept terrestrial animals and germinal products to another Member State or receive kept terrestrial animals and germinal products from a third country;

               (f)establishments included in the register of approved aquaculture establishments and disease control aquatic food establishments referred to in respectively Article 185(1)(b) and (c) of Regulation (EU) 2016/429 in so far as they move aquaculture animals to another Member State or receive aquaculture animals from a third country;

               (g)establishments and operators included in the register of registered establishments and operators referred to in point (a) of the first subparagraph of paragraph 1 of Article 101 of Regulation (EU) 2016/429 in so far as they move kept terrestrial animals and germinal products to another Member State or receive kept terrestrial animals and germinal products from a third country;

               (h)establishments included in the register of registered aquaculture establishments referred to in Article 185(1)(a) of Regulation (EU) 2016/429 in so far as they move aquaculture animals to another Member State or receive aquaculture animals from a third country;

               (i)transporters to which the competent authority has granted an authorisation pursuant to Article 10(1) of Regulation (EC) No 1/2005;

               (j)drivers and attendants of road vehicles transporting domestic Equidae or domestic animals of bovine, ovine, caprine or porcine species or poultry to which the competent authority has granted a certificate of competence pursuant to Article 17(2) of Regulation (EC) No 1/2005;

               (k)means of transport by road used for long journeys and livestock vessels to which the competent authority has granted a certificate of approval pursuant to respectively Articles 18(1) and 19(1) of Regulation (EC) No 1/2005;

               (l)operators included in the register of professional operators introducing into the Union plants, plant products and other objects for which a phytosanitary certificate is required as referred to in point (a) of the first subparagraph of Article 65(1) of Regulation (EU) 2016/2031;

               (m)quarantine stations and confinement facilities designated in accordance with Article 60 of Regulation (EU) 2016/2031 to carry out activities involving plants, plant products and other objects introduced into the Union territory from third countries.

               2.The contact points referred to in paragraph 1 shall insert in TRACES information concerning each list referred to in that paragraph using the technical specifications for the format of these lists provided by the Commission.

               3.The Commission shall assist the Member States in making the lists referred to in points (a) to (f) of paragraph 1 available to the public through publication on its website or through TRACES.

               ------------

               *Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC (OJ L 174, 2.7.1997, p. 1).

               **Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).’.

               Article 2

               Repeal

               Decision 97/152/EC is repealed.

               Article 3

               Entry into force and application

               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 21 April 2021, except for Article 1(5), which shall apply from 1 December 2021.

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 29.3.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 31, 1.2.2002, p. 1.

                     (2)

                        OJ L 84, 31.3.2016, p. 1.

                     (3)

                        OJ L 317, 23.11.2016, p. 4.

                     (4)

                        OJ L 95, 7.4.2017, p. 1.

                     (5)

                        Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (‘the IMSOC Regulation’) (OJ L 261, 14.10.2019, p. 37).

                     (6)

                        Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system (OJ L 412, 8.12.2020, p. 1).

                     (7)

                        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).

                     (8)

                        Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

                     (9)

                        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).

                     (10)

                        Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1).

                     (11)

                        Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for control posts and amending the route plan referred to in the Annex to Directive 91/628/EEC (OJ L 174, 2.7.1997, p. 1).

                     (12)

                        Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).

                     (13)

                        Commission Decision 97/152/EC of 10 February 1997 concerning the information to be entered in the computerized file of consignments of animals or animal products from third countries which are re-dispatched (OJ L 59, 28.2.1997, p. 50).

                     (14)

                        Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC (OJ L 243, 25.8.1992, p. 27).

                     (15)

                        Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 31.5.2021

               laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008

               (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 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
                  1
               , and in particular Article 74(1) and 132 thereof,

               Whereas:

               (1)Article 56(1) of Regulation (EC) No 1907/2006 sets out an authorisation requirement for the placing on the market and the use of substances of very high concern listed in Annex XIV to that Regulation. The compliance with that requirement, in certain cases, constitutes a significant administrative burden for undertakings. In its Communication of 18 June 2014 “Regulatory Fitness and Performance Programme (REFIT): State of Play and Outlook”
                  2
                the Commission announced that it was considering simplifying the authorisation process in some specific cases. Simplifying the applications for continued use of substances of very high concern in the production of legacy spare parts was identified as one of the actions in the Commission Communication of 5 March 2018 “Commission General Report on the operation of REACH and review of certain elements”
                  3
               .

               (2)The Commission Communication of 2 December 2015 “Closing the loop – An EU action plan for the Circular Economy”
                  4
                describes that the extension of the lifetime of products by way of repair helps avoid wastage. The Council conclusions of 20 June 2016 on that action plan
                  5
                invite the Commission to investigate what initiatives can be taken at Union level in the interest of extending the lifetime of products, in particular by promoting the availability of spare parts.

               (3)In order to avoid the premature obsolescence of articles or complex products
                  6
                that are no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC) No 1907/2006, spare parts as well as substances and mixtures that are necessary for the repair of such articles or complex products need to continue to be made available on the market and used. If a substance listed in Annex XIV to Regulation (EC) No 1907/2006 has been used to produce such articles or complex products and, if after the sunset date the spare part cannot be produced or the product cannot be repaired without the use of that substance, the requirements as regards the content of the application for authorisation and of the review report of an authorisation for such uses should be clarified in order to simplify such applications for authorisation.

               (4)As regards the analysis of alternatives referred to in Article 62(4)(e) of Regulation (EC) No 1907/2006, providing justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance, should be considered sufficient to conclude on the lack of suitable alternatives. As the use of the substance in the production of such spare parts or repair of such articles or complex products will gradually decrease  since its intended use is for a product that is no longer produced, while the substitution costs for research and development, testing, qualification, and industrialisation of possible alternatives for such uses are likely to be high in view of the expected decreasing trend, such provision is deemed justified.

               (5)Similarly, the justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance should be considered sufficient in order to demonstrate the socio-economic benefits of the use of the substance in the socio-economic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006. The non-availability of spare parts or the impossibility to repair articles or complex products no longer produced without that substance would lead to the premature obsolescence of those articles or complex products before the end of their lifetime use and therefore to their premature disposal, likely causing high costs to operators, consumers or society. Moreover, the number of uses and quantities of the substance used for such spare parts are expected to decrease, leading to a diminishing impact on human health and the environment associated with the exposure to or emission of the substance used. It is therefore appropriate that contents of the socio-economic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006 be provided by the applicant in a succinct form. This is without prejudice to the consideration of the risk posed by the use of the substance to human health or the environment and to the need for the applicant to demonstrate that socio-economic benefits outweigh that risk.

               (6)The clarification of the content of applications for authorisation for the use of a substance in the production of spare parts for repair or in the repair of articles and complex products no longer produced should result in a reduction of the workload for the European Chemicals Agency (‘the Agency’) in assessing applications for authorisation in those specific cases. The fees levied for such applications should be proportionate to the expected workload of the Agency in such cases and, hence, be reduced when compared to the fee levied for the applications for other uses. For the same reasons, the charges applicable to the review of authorisations granted for those uses should be reduced by the same proportion.

               (7)Commission Regulation (EC) No 340/2008
                  7
                should therefore be amended accordingly.

               (8)The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,

               HAS ADOPTED THIS REGULATION:

               Article 1

               This Regulation implements Articles 61(1), 62(4)(e) and 62(5)(a) of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for any of the following uses of a substance, on its own or in a mixture, listed in Annex XIV to that Regulation

               (a)the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance (‘production of legacy spare parts’);

               (b)the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance (‘repair of articles or complex products no longer produced’).

               Article 2

               1.An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (e) of Article 62(4) of that Regulation when it includes the following:

               (a)a description and analysis of the function of the substance, and

               (b)a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled.

               2.An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with  point (a) of Article 62(5) of that Regulation when it includes the following:

               (a)a succinct description of the human health or environmental impacts in accordance with the information provided in the chemical safety report;

               (b)a succinct description of the socio-economic benefits of the use applied for, including a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled;

               (c)a conclusion based on a comparison of the risks and benefits of the use of the substance applied for, as described in points (a) and (b) of this paragraph.

               3.Where the application for authorisation is submitted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced, information referred to in paragraphs 1 and 2 of this Article, together with any third party contributions on possible alternatives submitted in accordance with Article 64(2) of Regulation (EC) No 1907/2006, shall suffice for the purpose of assessing the socio-economic factors and the suitability of the alternatives associated with the use of the substance.

               4.Paragraphs 1, 2 and 3 of this Article shall apply mutatis mutandis to review reports submitted pursuant to Article 61(1) of Regulation (EC) No 1907/2006 concerning an authorisation granted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced.

               5.By [insert date - 14 days after date of entry into force] the European Chemicals Agency (‘the Agency’) shall make publicly available specific formats for the analysis of alternatives and the socio-economic analysis to be used in applications for authorisation for uses of substances in the production of legacy spare parts or in the repair of articles or complex products no longer produced as well as in review reports concerning an authorisation granted for such uses, submitted in accordance with this Regulation, reflecting the elements referred to in paragraphs 1 and 2.

               Article 3

               Regulation (EC) No 340/2008 is amended as follows:

               (1)In Article 8(2), the following subparagraph is added after the fourth subparagraph:

               ‘The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Commission Implementing Regulation …*
                  8+  and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation.

               _______________

               *
                     Commission Implementing Regulation .../... of … on ... (OJ ...).ʼ.

               (2)In Article 9(2), the following subparagraph is inserted after the fourth subparagraph:

               ʻThe Agency shall levy a reduced charge as set out in point 2 of Annex VII to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Implementing Regulation …+ and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation’.

               (3)Annexes VI and VII are replaced by the text as set out in the Annex to this Regulation.

               Article 4

               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 31.5.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 396, 30.12.2006, p. 1

                     (2)

                        COM(2014) 368 final

                     (3)

                        COM(2018) 116 final

                     (4)

                        COM(2015) 614 final

                     (5)

                        Closing the loop - An EU action plan for the Circular Economy - Council conclusions of 20 June 2016, ST 10518 2016 INIT.

                     (6)

                        ‘Complex products’ as described in the judgment of the Court of Justice of 10 September 2015, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB), C‑106/14, ECLI:EU:C:2015:576, paragraphs 48-54.

                     (7)

                        Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 107 17.4.2008, p. 6).

                     (8)
                  +
                        OJ Please insert in the text the number of this Implementing Regulation and insert the number, date, title and OJ reference of this Implementing Regulation in the footnote.

    ---documentbreak---

               ANNEX

               ‘ANNEX VI

               Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006

               1.
                     Fees for applications for an authorisation

               Table 1

               Standard fees

                        Base fee

                        EUR 54 100

                        Additional fee per substance

                        EUR 10 820

                        Additional fee per use

                        EUR 48 690

               Table 2

               Reduced fees for medium enterprises

                        Base fee

                        EUR 40 575

                        Additional fee per substance

                        EUR 8 115

                        Additional fee per use

                        EUR 36 518

               Table 3

               Reduced fees for small enterprises

                        Base fee

                        EUR 24 345

                        Additional fee per substance

                        EUR 4 869

                        Additional fee per use

                        EUR 21 911

               Table 4

               Reduced fees for micro enterprises

                        Base fee

                        EUR 5 410

                        Additional fee per substance

                        EUR 1 082

                        Additional fee per use

                        EUR 4 869

               2.
                     Fees for applications for an authorisation for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 8(2)

               Table 1

               Standard fees

                        Base fee

                        EUR 27 050

                        Additional fee per substance

                        EUR 5 410

                        Additional fee per use

                        EUR 24 345

               Table 2

               Reduced fees for medium enterprises

                        Base fee

                        EUR 20 287

                        Additional fee per substance

                        EUR 4 057

                        Additional fee per use

                        EUR 18 259

               Table 3

               Reduced fees for small enterprises

                        Base fee

                        EUR 12 172

                        Additional fee per substance

                        EUR 2 434

                        Additional fee per use

                        EUR 10 955

               Table 4

               Reduced fees for micro enterprises

                        Base fee

                        EUR 2 705

                        Additional fee per substance

                        EUR    541

                        Additional fee per use

                        EUR    2 434

               ANNEX VII

               Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006

               1.
                     Charges for the review of an authorisation

               Table 1

               Standard charges

                        Base charge

                        EUR 54 100

                        Additional charge per substance

                        EUR 10 820

                        Additional charge per use

                        EUR 48 690

               Table 2

               Reduced charges for medium enterprises

                        Base charge

                        EUR 40 575

                        Additional charge per substance

                        EUR 8 115

                        Additional charge per use

                        EUR 36 518

               Table 3

               Reduced charges for small enterprises

                        Base charge

                        EUR 24 345

                        Additional charge per substance

                        EUR 4 869

                        Additional charge per use

                        EUR 21 911

               Table 4

               Reduced charges for micro enterprises

                        Base charge

                        EUR 5 410

                        Additional charge per substance

                        EUR 1 082

                        Additional charge per use

                        EUR 4 869

               2.
                     Charges for the review of an authorisation granted for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 9(2)

               Table 1

               Standard charges

                        Base charge

                        EUR 27 050

                        Additional charge per substance

                        EUR 5 410

                        Additional charge per use

                        EUR 24 345

               Table 2

               Reduced charges for medium enterprises

                        Base charge

                        EUR 20 287

                        Additional charge per substance

                        EUR 4 057

                        Additional charge per use

                        EUR 18 259

               Table 3

               Reduced charges for small enterprises

                        Base charge

                        EUR 12 172

                        Additional charge per substance

                        EUR 2 434

                        Additional charge per use

                        EUR 10 955

               Table 4

               Reduced charges for micro enterprises

                        Base charge

                        EUR 2 705

                        Additional charge per substance

                        EUR    541

                        Additional charge per use

                        EUR    2 434

               ’