(1)

Annex III to Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators.

(2)

Rennet is a complex of enzymes used for the production of certain cheeses. It is collected from the stomachs of young ruminants. Based on the experience gained by food business operators, the specific hygiene requirements on stomachs for the production of rennet, laid down in Point 18(a) of Chapter IV to Section I to Annex III of Regulation (EC) No 853/2004, should be amended in order to optimise the collection of rennet from young sheep and goats. In particular, it is appropriate to allow such stomachs to leave the slaughterhouse without being emptied or cleaned.

(3)

Technological developments have resulted in a demand for heads and feet of domestic ungulates to be permitted to be skinned or scalded and depilated outside the slaughterhouse in specialised approved establishments for further processing of food. As a practical consequence, heads and feet of domestic ungulates should therefore be allowed to be transported to these establishments under certain conditions that ensure food safety. Point 18(c) of Chapter IV to Section I of Annex III to Regulation (EC) No 853/2004 should therefore be amended.

(4)

In accordance with Article 4 of Commission Delegated Regulation (EU) 2019/624 (2), the official veterinarian may perform ante-mortem inspection outside a slaughterhouse in the case of emergency slaughter of domestic ungulates. Point 2 of Chapter VI of Section I of Annex III to Regulation (EC) No 853/2004 requires a veterinarian to carry out ante mortem inspection in the case of emergency slaughter. That requirement should be amended so as to be consistent with that Article 4 of Delegated Regulation (EU) 2019/624 and refer instead to the official veterinarian.

(5)

Improving animal welfare is one of the actions proposed in the Commission’s Farm to Fork Strategy (3) for a fair, healthy and environmentally-friendly food system, as part of the European Green Deal. There is, in particular, a change in patterns of meat consumption with an increasing demand by the European Parliament, farmers and consumers that slaughter of certain domestic ungulates on the holding of provenance be authorised in order to avoid possible animal welfare concerns during collection and transport thereof.

(6)

Apart from emergency slaughter, domestic ungulates are required to be slaughtered in a slaughterhouse approved in accordance with Article 4(2) of Regulation (EC) No 853/2004 to ensure compliance with the hygiene requirements laid down in Chapters II and IV of Section I of Annex III to that Regulation. The competent authorities of Member States can approve mobile slaughterhouses in accordance with that Article. These mobile facilities may be placed in all appropriate locations, including farms, where groups of healthy animals can be slaughtered. In other circumstances, the transport of certain animals may create a risk for the handler or for the welfare of the animals. Slaughter and bleeding should therefore be permitted at the holding of provenance for a limited number of domestic bovine and porcine animals and domestic solipeds. Such practice should be subject to strict conditions to maintain a high level of food safety of the meat derived from such animal.

(7)

Domestic bovine and porcine animals and domestic solipeds slaughtered on the holding of provenance, should be accompanied by an official certificate, attesting that the hygiene requirements for slaughter have been complied with. Such an official certificate is provided for in Commission Implementing Regulation (EU) 2020/2235 (4).

(8)

On 27 September 2018, the European Food Safety Authority (EFSA) adopted a second scientific opinion on hazard analysis approaches for certain small retail establishments and food donations (5). That Opinion recommends freezing at retail level as an additional tool for guaranteeing the safe redistribution of food to those in need. The facilitation of safe food donation practices, both prevents food waste and contributes to food security, in line with the objectives laid down in the Commission’s Farm to Fork strategy and its overall aim to establish a fair, healthy and environmentally-friendly food system as part of the European Green Deal. The freezing of food can be an important means of ensuring its safe redistribution by food banks and other charities. The freezing of meat is currently not allowed in the case of retail to retail activity since meat intended for freezing is required to be frozen without undue delay after slaughter or cutting in accordance with point 4 of Chapter VII of Section I of Annex III to Regulation (EC) No 853/2004, as regards domestic ungulates and point 5 of Chapter V of Section II of that Annex as regards poultry and lagomorphs. The freezing of meat should therefore be allowed in the case of retail to retail activity under certain conditions to ensure the safe distribution for food donations.

(9)

Regulation (EC) No 854/2004 of the European Parliament and of the Council (6) defined ‘approved veterinarian’. Regulation (EU) 2017/625 of the European Parliament and of the Council (7) repealed Regulation (EC) No 854/2004, and defined ‘official veterinarian’. As the definition of ‘official veterinarian’ in Regulation (EU) 2017/625 encompasses ‘approved veterinarian’, the references to ‘approved veterinarian’ in Annex III to Regulation (EC) No 853/2004 should be amended to refer instead to ‘official veterinarian’

(10)

The specific hygiene requirements for the production and placing on the market of meat from even-toed farmed game mammals laid down in Section III of Annex III to Regulation (EC) No 853/2004 only apply to meat from Cervidae or Suidae. Similar requirements should also apply to meat from other even-toed farmed game mammals such as lamas to avoid a possible food safety risk from changes in consumption patterns due to an increased consumption of such meat.

(11)

The bodies and viscera of hunted wild game may be transported to and stored in a collection centre before transport to a game-handling establishment. Specific hygiene rules on the handling and storage of these bodies and viscera in such collection centres should be introduced to ensure the food safety of that meat by amending the hygiene requirements for wild game laid down in Section IV of Annex III to Regulation (EC) No 853/2004.

(12)

Wild game is required to be transported as soon as possible to a game handling establishment after examination by a trained person in accordance with point 3 of Chapter II of Section IV of Annex III to Regulation (EC) No 853/2004 as regards large wild game and point 3 of Chapter III of that Section as regards small wild game in order to allow chilling to take place within a reasonable time after killing. That requirement should also apply to wild game where no examination took place.

(13)

Point 3 of Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004, provides that whenever a food business operator moves a batch of live bivalve molluscs between establishments, the batch is required to be accompanied by a registration document. In order to harmonise the information required by point 4 of Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004, a common model of the registration document for the movement of live bivalve molluscs between establishments should be established. Moreover it is a common practice that batches of bivalve molluscs may also be sent to intermediate operators, therefore the registration document should also include this possibility.

(14)

In accordance with point 1 of Part A of Chapter IV of Section VII of Annex III to Regulation (EC) No 853/2004, live bivalve molluscs are to be washed with clean water, free of mud and accumulated debris before purification commences. However, in order to save water, washing of clean bivalve molluscs should not be mandatory. The point 1 of Part A of Chapter IV of Section VII should be modified accordingly.

(15)

Live bivalve molluscs placed on the market may not contain marine biotoxins that exceed the limits set out in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004. The EFSA has concluded in its Opinion on Marine biotoxins in shellfish – Pectenotoxin group (8) that there are no reports of adverse effects in humans associated with Pectenotoxins (PTX) group toxins. In addition, PTX in shellfish are always accompanied by toxins from the Okadaic acid group. It is therefore appropriate to delete the reference to PTX from point 2(c) of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004.

(16)

Article 11 of Delegated Regulation 2019/624 provides that the classification of production and relaying areas is not required in relation to the harvesting of holothuroidea when the competent authorities carry out official controls on such animals in fish auctions, dispatch centres and processing establishments. Chapter IX of Section VII of Annex III to Regulation (EC) No 853/2004 should be amended in order to allow the harvesting of Holothuroidea outside classified production and relaying areas.

(17)

Vessels should be designed and constructed so as not to cause contamination of fishery products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances. Also holds, tanks or containers used for storing, cooling or freezing fishery products should not be used for other purposes than the storage of fishery products. Freezer vessels and reefer vessels should be equipped with freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Storage holds should not be used for freezing products. The same requirements for freezing and storage equipment should also apply to cold stores on land. Part I of Chapter I and part B of Chapter III of Section VIII of Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.

(18)

Following recent frauds concerning tuna initially frozen in brine at – 9 °C and destined for the canning industry but diverted to be consumed as fresh fishery products, it is appropriate to clarify in point 7 of Part II of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004 that whole fishery products initially frozen in brine at – 9 °C and destined for the canning industry even if further frozen at a temperature of – 18 °C must not have a different destination than the canning industry.

(19)

Livers and roes of fishery products intended for human consumption are to be preserved under ice, at a temperature approaching that of melting ice, or are to be frozen. It is appropriate to allow that livers and roes be also refrigerated under different conditions than under ice, at a temperature approaching that of melting ice. Accordingly, point 6 of Part II of Chapter I of Section VIII of Annex III to Regulation (EC) No 853/2004 should be amended in order to allow that livers and roes of fishery products intended for human consumption may also be refrigerated not only under ice but under different conditions of refrigeration.

(20)

It is appropriate that in containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice, the melting water should not remain in contact with any fishery products. It is important, for hygiene reasons, to clarify that melt water not only should not remain in contact with fishery products but should be drained away. Accordingly, point 4 of part A of Chapter III of Section VIII of Annex III to Regulation (EC) No 853/2004 should be amended in order to clarify that melted water not only should not remain in contact with fishery products but should be drained away.

(21)

Specific hygiene rules on frogs’ legs laid down in Section XI of Annex III to Regulation (EC) No 853/2004 only apply to frogs’ legs of the species RNA (family Ranidae) in accordance with the definition of frogs’ legs laid down in point 6.1 of Annex I to that Regulation. Specific hygiene rules for snails in that Section only apply to terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and species of the family Achatinidae in accordance with the definition of snails laid down in point 6.2 of Annex I to Regulation (EC) No 853/2004. Due to changes in eating habits, frogs’ legs and snails of other species are also produced and placed on the market for human consumption. The specific hygiene rules should therefore be extended to cover those species to ensure the safety of food derived from these species.

(22)

Section XII of Annex III to Regulation (EC) No 853/2004 lays down specific temperature requirements for the storage of greaves intended for human consumption. Technological developments have allowed certain packaging techniques, such as vacuum-packaging for which the specific temperature requirements are not needed to ensure the safety of food derived from greaves. Those temperature conditions should therefore be deleted while the food business operator should ensure the safety of food derived from the greaves by good hygiene practices and procedures based on Hazard Analysis and Critical Control Point (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council (9).

(23)

Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly,

(1)

Commission Delegated Regulation (EU) 2019/33 (2), which replaced and repealed Commission Regulation (EC) No 607/2009 (3), lays down rules supplementing Regulation (EU) No 1308/2013 as regards protection, cancellation and modification of traditional terms.

(2)

Article 34 of Delegated Regulation (EU) 2019/33 lays down that the modification of a registered traditional term may only concern the elements referred to in points (b), (c) and (d) of Article 26(1), of that Regulation, which refer respectively to the type of the traditional term, the language in which the traditional term is expressed and the grapevine product category concerned by its use.

(3)

However, Article 42a of Regulation (EC) No 607/2009 provided for a longer list of possible modifications. In particular, it included the possibility to modify the traditional term itself, the language in which the traditional term is indicated, the wine or wines concerned and the summary of the definition or conditions of use of the traditional term. The modification possibilities under Regulation (EC) No 607/2009 were therefore broader and allowed wine producers to extend or limit, for example, the list of wines with protected designations of origin or protected geographical indications authorised to use a traditional term or to amend the conditions for the use of a traditional term, including the production methods of the concerned wines.

(4)

The provisions of Delegated Regulation (EU) 2019/33 concerning traditional terms were drafted with the intention of ensuring continuity of the common framework related to traditional terms established under Regulation (EC) No 607/2009, while completing and clarifying the existing procedures whenever necessary. Article 34 of Delegated Regulation (EU) 2019/33 makes direct references to the elements of a duly completed application form, as set out in Article 26(1) of that Regulation. However, due to an involuntary omission, point (a) of Article 26(1), referring to the name of the concerned traditional term, point (e) of Article 26(1), referring to the summary of the definition and conditions of use and point (f) of Article 26(1), referring to the protected designations of origin or protected geographical indications concerned, were not mentioned in the list set out in Article 34, even though these elements were included in Article 42a of Regulation (EC) No 607/2009. This has the unintended consequence that the possibilities for modifying a traditional term are restricted to modifying the type of traditional term, the language and the grapevine product category concerned.

(5)

In practical terms, the current wording of the first paragraph of Article 34 hinders the possibility to extend the use of a traditional term to new protected designations of origin or geographical indications or to exclude from the list of wines authorised to use a traditional term those that no longer comply with its conditions of use. Moreover, it does not allow, for example, to adapt the production methods mentioned in the specifications of a traditional term in case those methods evolve due to the changing environmental or climate conditions.

(6)

To correct this unintended omission and restore the flexibility granted to holders of traditional terms under Regulation (EC) No 607/2009, the list of possible modifications of a registered traditional term referred to in the first paragraph of Article 34 of Delegated Regulation (EU) 2019/33 should be extended to include the elements referred to in points (a), (e) and (f) of Article 26(1) of that Regulation.

(7)

Delegated Regulation (EU) 2019/33 should therefore be amended accordingly.

(8)

For reasons of legal clarity and in order to ensure equal treatment of all applications for modification of a registered traditional term, this Regulation should apply retroactively from 14 January 2019,

(1)

Council Regulation (EU) 2021/92 (2) lays down quotas for 2021.

(2)

According to the information received by the Commission, catches of the stock of redfishes in NAFO 3M area by vessels flying the flag of or registered in a Member State of the European Union have exhausted the quota allocated for 2021.

(3)

It is therefore necessary to prohibit directed fishing activities for that stock,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

The novel food ‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ has been authorised pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) for use in food supplements intended for the general population, as defined in Directive 2002/46/EC of the European Parliament and of the Council (4). The maximum authorised levels of the astaxanthin-rich oleoresin from Haematococcus pluvialis algae for the general population is currently 40-80 mg per day of oleoresin, resulting in ≤ 8,0 mg astaxanthin per day.

(5)

At the time of the establishment of the Union list of authorised novel foods in 2017, the Commission considered that, based on previous two opinions (5) , (6) of 2014 of the European Food Safety Authority (‘the Authority’), one on the use of astaxanthin in feed additives as defined in Regulation (EC) No 1831/2003 of the European Parliament and the Council (7) on feed additives for animal nutrition, that established an Acceptable Daily Intake (‘ADI’) of 0,034 mg/kg body weight per day for astaxanthin, and one on the safety of astaxanthin as a novel food ingredient, the intake of astaxanthin from food supplements containing the maximum authorised use levels of up to 8,0 mg per day, may exceed the ADI and may not be in accordance with the conditions set out in Article 7 of Regulation (EU) 2015/2283. The Commission considered that the Union list should be amended to adjust the authorised levels of astaxanthin in light of the 2014 Authority opinions.

(6)

The Commission also became aware of new scientific evidence in 2017, submitted by business operators during the public consultation of the draft Implementing Regulation establishing the Union list of authorised novel foods, pointing to a considerably higher ADI for astaxanthin than the one previously established by the Authority. In addition, evidence submitted during the same public consultation demonstrated that there already existed a considerable intake of astaxanthin from the normal diet as it is naturally present in some fish and crustaceans.

(7)

On 27 February 2018, the Commission, in accordance with Article 29(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8) requested the Authority to deliver an opinion on the safety of astaxanthin when used as a novel food in food supplements at levels of up to 8,0 mg/day, taking into account the overall cumulative intake of astaxanthin from all food sources.

(8)

On 18 December 2019, the Authority adopted its scientific opinion ‘Safety of astaxanthin for its use as a novel food in food supplements’ (9).

(9)

In its scientific opinion, the Authority concluded that on the basis of the new evidence, the ADI for astaxanthin is 0,2 mg/kg body weight per day. Taking into account the astaxanthin ADI and the intake of astaxanthin from the normal diet, the Authority concluded that the intake of the maximum currently authorised levels of up to 8,0 mg/day astaxanthin from food supplements containing astaxanthin-rich oleoresin from Haematococcus pluvialis algae is safe for adults and adolescents above 14 years old.

(10)

A clear designation of the novel food and a labelling requirement should be laid down for food supplements containing astaxanthin-rich oleoresin from Haematococcus pluvialis algae in order ensure that those food supplements are not consumed by children and adolescents aged less than 14 years of age.

(11)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(12)

Evidence form the market place seems to indicate that although food supplements containing ≤ 8,0 mg astaxanthin are currently authorised for the general population, in practice they are not used by children and adolsescents but are almost exclusively used by the adult population. In order to limit the administrative burden and to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional periods should be laid down to cover food supplements containing ≤ 8,0 mg astaxanthin which have been placed on the market or dispatched from third countries for the Union and are intended for the general population, before the date of entry into force of this Regulation. Those transitional measures should take into account the safety of consumers by providing them the information about the appropriate use in line with the requirements of this Regulation.

(13)

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

(1)

In accordance with point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, a product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as in-conversion product, if operators and groups of operators, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46 of that Regulation, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with Regulation (EU) 2018/848.

(2)

In order to give effect to point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, the content of the certificate referred to in that provision should be specified, as well as the technical means by which it is to be issued.

(3)

In addition, for the purposes of point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, it is appropriate to establish in this Regulation the list of recognised control authorities and control bodies that are competent to carry out those controls and to issue that certificate in third countries.

(4)

In the interest of clarity and legal certainty, this Regulation should apply from the date of application of Regulation (EU) 2018/848.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee,

(a)

be issued in electronic form, in accordance with the model set out in Annex I to this Regulation, and by using the electronic Trade Control and Expert System (TRACES) referred to in point (36) of Article 2 of Commission Implementing Regulation (EU) 2019/1715 (2);

(b)

allow the identification of:

(c)

certify that the activity of the operator, group of operators or exporter complies with Regulation (EU) 2018/848; and

(d)

be updated whenever changes occur concerning the data included in it.

(1)

Commission Directive 2002/64/EC (2) included famoxadone as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance famoxadone, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2022.

(4)

An application for the renewal of the approval of famoxadone was submitted in accordance with Article 4 of Commission Implementing Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Implementing Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 15 July 2014.

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 3 July 2015 the Authority communicated to the Commission its conclusion (6) on whether famoxadone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that there is a high potential for all the representative uses assessed to exceed the acceptable operator exposure level (‘AOEL’) for workers during crop hand-harvesting even with the use of personal protective equipment (‘PPE’). The Authority further concluded that there is a high long-term risk for mammals and high risk for aquatic organisms from the use of famoxadone. In addition, the Authority stated that the available information is insufficient to conclude on the the long-term risk assessments for birds.

(9)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 17(1) of Implementing Regulation (EU) No 1141/2010, on the draft review report. The applicant submitted its comments, which have been carefully examined.

(10)

However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

(11)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance famoxadone in accordance with Article 20(1)(b) of that Regulation.

(12)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(13)

Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing famoxadone.

(14)

For plant protection products containing famoxadone, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and not exceed 12 months from the date of entry into force of this Regulation.

(15)

Implementing Regulation (EU) 2021/745 (7) extended the approval period of famoxadone to 30 June 2022 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.

(16)

This Regulation does not prevent the submission of a further application for the approval of famoxadone pursuant to Article 7 of Regulation (EC) No 1107/2009.

(17)

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

(1)

Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.

(2)

Regulation (EU) 2021/953 allows for the acceptance of COVID-19 certificates issued by third countries to Union citizens and their family members where the Commission finds that those COVID-19 certificates are issued in accordance with standards that are to be considered as equivalent to those established pursuant to that Regulation. Furthermore, in accordance with Regulation (EU) 2021/954 of the European Parliament and of the Council (2), Member States have to apply the rules laid down in Regulation (EU) 2021/953 to third-country nationals who do not fall within the scope of that Regulation, but who are legally staying or residing in their territory and who are entitled to travel to other Member States in accordance with Union law. Therefore, any equivalence findings laid down in this Decision should apply to COVID-19 vaccination certificates issued by Ukraine to Union citizens and their family members. Similarly, on the basis of Regulation (EU) 2021/954, such equivalence findings should also apply to COVID-19 vaccination certificates issued by Ukraine to third-country nationals legally staying or residing in the territory of the Member States under the conditions laid down in that Regulation.

(3)

On 16 July 2021, Ukraine provided the Commission with detailed information on the issuance of interoperable COVID-19 vaccination, test and recovery certificates under the system entitled ‘Single State portal of electronic services’ (Diia portal and mobile application)Ukraine informed the Commission that it considered that its COVID-19 certificates are being issued in accordance with a standard and a technological system that are interoperable with the trust framework established by Regulation (EU) 2021/953 and that allow for the verification of the authenticity, validity and integrity of the certificates. In this regard, Ukraine informed the Commission that COVID-19 certificates issued by Ukraine in accordance with the ‘Single State portal of electronic services’ (Diia portal and mobile application) system contain the data set out in the Annex of Regulation (EU) 2021/953.

(4)

On 4 August 2021, following a request by Ukraine, the Commission carried out technical tests that demonstrated that the COVID-19 vaccination, test and recovery certificates are issued by Ukraine in accordance with a system, the ‘Single State portal of electronic services’ (Diia portal and mobile application), that is interoperable with the trust framework established by Regulation (EU) 2021/953 and allows for the verification of their authenticity, validity and integrity. The Commission also confirmed that the COVID-19 vaccination, test and recovery certificates issued by Ukraine in accordance with the ‘Single State portal of electronic services’ (Diia portal and mobile application) system contain the necessary data.

(5)

In addition, the Ukraine informed the Commission that it will issue interoperable vaccination certificates for COVID-19 vaccines. These currently include Vaxzevria, Comirnaty, Spikevax, COVID-19 Vaccine Janssen, CoronaVac-COVID-19 Vaccine (Vero Cell) Inactivated, Covishield, and NVX-CoV2373.

(6)

Ukraine also informed the Commission that it will issue interoperable test certificates only for nucleic acid amplification tests or for rapid antigen tests listed in the common and updated list of COVID-19 rapid antigen tests agreed by the Health Security Committee, established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (3), on the basis of the Council Recommendation of 21 January 2021 (4).

(7)

Furthermore, Ukraine informed the Commission that it issues interoperable certificates of recovery at the earliest 14 days after a positive test. Those certificates are valid for not more than 180 days after the date of the first positive test.

(8)

Ukraine also informed the Commission that it accepts vaccination, test and recovery certificates issued by the Member States, EEA countries, and other countries in respect of which an implementing decision is adopted pursuant to Article 8(2) of Regulation (EU) 2021/953. Ukraine also informed the Commission that people with EU Digital COVID Certificate test certificate for negative NAAT test and EU Digital COVID Certificate test certificate for negative RAT test are allowed to enter Ukraine, but like for the Ukrainian citizens, it is required for them to make additional NAAT\RAT test within 72 hours.

(9)

In addition, Ukraine informed the Commission that when verifiers in Ukraine verify certificates, the personal data included in them will be processed only to verify and confirm the holder’s vaccination, test result or recovery status and will not be retained afterwards.

(10)

The necessary elements for establishing that COVID-19 certificates issued by Ukraine in accordance with the ‘Single State portal of electronic services’ (Diia portal and mobile application) system are to be considered as equivalent to those issued in accordance with Regulation (EU) 2021/953 are thus fulfilled.

(11)

Therefore, COVID-19 certificates issued by Ukraine in accordance with the ‘Single State portal of electronic services’ (Diia portal and mobile application) system should be accepted under the conditions referred to in Article 5(5), Article 6(5), and Article 7(8) of Regulation (EU) 2021/953.

(12)

In order for this Decision to be operational, Ukraine should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

(13)

In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend or terminate this Decision if the conditions of Article 8(2) of Regulation (EU) 2021/953 are no longer met.

(14)

In the light of the need to connect Ukraine to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the Official Journal of the European Union.

(15)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,

(1)

Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.

(2)

Regulation (EU) 2021/953 allows for the acceptance of COVID-19 certificates issued by third countries to Union citizens and their family members where the Commission finds that those COVID-19 certificates are issued in accordance with standards that are to be considered as equivalent to those established pursuant to that Regulation. Furthermore, in accordance with Regulation (EU) 2021/954 of the European Parliament and of the Council (2), Member States have to apply the rules laid down in Regulation (EU) 2021/953 to third-country nationals who do not fall within the scope of that Regulation, but who are legally staying or residing in their territory and who are entitled to travel to other Member States in accordance with Union law. Therefore, any equivalence findings laid down in this Decision should apply to COVID-19 vaccination, test and recovery certificates issued by North Macedonia to Union citizens and their family members. Similarly, on the basis of Regulation (EU) 2021/954, such equivalence findings should also apply to COVID-19 vaccination, test and recovery certificates issued by North Macedonia to third-country nationals legally staying or residing on the territory of the Member States under the conditions laid down in that Regulation.

(3)

On 8 July 2021, North Macedonia provided the Commission with detailed information on the issuance of interoperable COVID-19 vaccination, test and recovery certificates under the National e-Health System. North Macedonia informed the Commission that it considered that its COVID-19 vaccination, test and recovery certificates are being issued in accordance with a standard and a technological system that are interoperable with the trust framework established by Regulation (EU) 2021/953 and that allow for the verification of the authenticity, validity and integrity of the certificates. In this regard, North Macedonia informed the Commission that COVID-19 vaccination, test and recovery certificates issued by North Macedonia in accordance with the National e-Health System contain the data referred to in the Annex to Regulation (EU) 2021/953.

(4)

On 26 July 2021, following a request by North Macedonia, the Commission carried out technical tests that demonstrated that the COVID-19 vaccination, test and recovery certificates are issued by North Macedonia in accordance with a system, the National e-Health System, that is interoperable with the trust framework established by Regulation (EU) 2021/953 and allows for the verification of the authenticity, validity and integrity of the certificates. The Commission also confirmed that the COVID-19 vaccination, test and recovery certificates issued by North Macedonia in accordance with the National e-Health System contain the necessary data.

(5)

In addition, North Macedonia informed the Commission that it will issue interoperable vaccination certificates for COVID-19 vaccines Vaxzevria, Comirnaty, Sputnik V, Sinopharm and Sinovac.

(6)

Furthermore, North Macedonia informed the Commission that it will issue interoperable test certificates only for nucleic acid amplification tests or for rapid antigen tests listed in the common and updated list of COVID-19 rapid antigen tests agreed by the Health Security Committee, established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (3), on the basis of the Council Recommendation of 21 January 2021 (4).

(7)

North Macedonia also informed the Commission that it accepts vaccination, test and recovery certificates issued by the Member States, EEA countries and other countries in respect of which an implementing decision is adopted pursuant to Article 8(2) of Regulation (EU) 2021/953.

(8)

In addition, North Macedonia informed the Commission that when verifiers in North Macedonia verify certificates, the personal data included in them will be processed only to verify and confirm the holder’s vaccination, test result or recovery status and will not be retained afterwards.

(9)

The necessary elements for establishing that COVID-19 vaccination, test and recovery certificates issued by North Macedonia in accordance with the National e-Health System are to be considered as equivalent to those issued in accordance with Regulation (EU) 2021/953 are thus fulfilled.

(10)

Therefore, COVID-19 vaccination, test and recovery certificates issued by North Macedonia in accordance with the National e-Health System should be accepted under the conditions referred to in Article 5(5), Article 6(5), and Article 7(8) of Regulation (EU) 2021/953.

(11)

In order for this Decision to be operational, North Macedonia should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

(12)

In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend or terminate this Decision if the conditions of Article 8(2) of Regulation (EU) 2021/953 are no longer met.

(13)

In light of the need to connect North Macedonia to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the Official Journal of the European Union.

(14)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,

(1)

Regulation (EU) 2021/953 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (‘EU Digital COVID Certificate’) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic. It is also to contribute to facilitating the gradual lifting of restrictions to free movement put in place by Member States, in accordance with Union law, to limit the spread of SARS-CoV-2, in a coordinated manner.

(2)

Regulation (EU) 2021/953 allows for the acceptance of COVID-19 certificates issued by third countries to Union citizens and their family members where the Commission finds that those COVID-19 certificates are issued in accordance with standards that are to be considered as equivalent to those established pursuant to that Regulation. Furthermore, in accordance with Regulation (EU) 2021/954 of the European Parliament and of the Council (2), Member States have to apply the rules laid down in Regulation (EU) 2021/953 to third-country nationals who do not fall within the scope of that Regulation, but who are legally staying or residing in their territory and who are entitled to travel to other Member States in accordance with Union law. Therefore, any equivalence findings laid down in this Decision should apply to COVID-19 vaccination certificates issued by the Republic of Turkey to Union citizens and their family members. Similarly, on the basis of Regulation (EU) 2021/954, such equivalence findings should also apply to COVID-19 vaccination certificates issued by the Republic of Turkey to third-country nationals legally staying or residing in the territory of the Member States under the conditions laid down in that Regulation.

(3)

On 9 July 2021, the Republic of Turkey provided the Commission with detailed information on the issuance of interoperable COVID-19 vaccination, test and recovery certificates under the system entitled ‘Health Pass’. The Republic of Turkey informed the Commission that it considered that its COVID-19 certificates are being issued in accordance with a standard and a technological system that are interoperable with the trust framework established by Regulation (EU) 2021/953 and that allow for the verification of the authenticity, validity and integrity of the certificates. In this regard, the Republic of Turkey informed the Commission that COVID-19 certificates issued by the Republic of Turkey in accordance with the ‘Health Pass’ system contain the data set out in the Annex to Regulation (EU) 2021/953.

(4)

On 26 July 2021, following a request by the Republic of Turkey, the Commission carried out technical tests that demonstrated that the COVID-19 vaccination, test and recovery certificates are issued by the Republic of Turkey in accordance with a system, the ‘Health Pass’, that is interoperable with the trust framework established by Regulation (EU) 2021/953, and allows for the verification of the authenticity, validity and integrity of the certificates. The Commission also confirmed that the COVID-19 vaccination, test and recovery certificates issued by the Republic of Turkey in accordance with the ‘Health Pass’ system contain the necessary data.

(5)

In addition, the Republic of Turkey informed the Commission that it will issue interoperable vaccination certificates for COVID-19 vaccines. These currently include Sinovac, Comirnaty and Sputnik V.

(6)

The Republic of Turkey also informed the Commission that it will issue interoperable test certificates only for nucleic acid amplification tests or for rapid antigen tests listed in the common and updated list of COVID-19 rapid antigen tests agreed by the Health Security Committee, established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council (3), on the basis of the Council Recommendation of 21 January 2021 (4).

(7)

Furthermore, the Republic of Turkey informed the Commission that it issues interoperable certificates of recovery at the earliest 21 days after a positive test. Those certificates are valid for not more than 180 days after the date of the first positive test.

(8)

The Republic of Turkey also informed the Commission that it accepts vaccination, test and recovery certificates issued by the Member States, EEA countries and other countries in respect of which an implementing decision is adopted pursuant to Article 8(2) of Regulation (EU) 2021/953.

(9)

In addition, the Republic of Turkey informed the Commission that when verifiers in Turkey verify certificates, the personal data included in them will be processed only to verify and confirm the holder’s vaccination, test result or recovery status and will not be retained afterwards.

(10)

The necessary elements for establishing that COVID-19 certificates issued by the Republic of Turkey in accordance with the ‘Health Pass’ system are to be considered as equivalent to those issued in accordance with Regulation (EU) 2021/953 are thus fulfilled.

(11)

Therefore, COVID-19 certificates issued by the Republic of Turkey in accordance with the ‘Health Pass’ system should be accepted under the conditions referred to in Article 5(5), Article 6(5), and Article 7(8) of Regulation (EU) 2021/953.

(12)

In order for this Decision to be operational, the Republic of Turkey should be connected to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953.

(13)

In order to protect the Union’s interests, in particular in the area of public health, the Commission may use its powers to suspend or terminate this Decision if the conditions of Article 8(2) of Regulation (EU) 2021/953 are no longer met.

(14)

In the light of the need to connect the Republic of Turkey to the EU Digital COVID Certificate trust framework established by Regulation (EU) 2021/953 as rapidly as possible, this Decision should enter into force on the day of its publication in the Official Journal of the European Union.

(15)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 14 of Regulation (EU) 2021/953,