(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-tryptophan produced by Escherichia coli KCCM 80210. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The application concerns the authorisation of L-tryptophan produced by Escherichia coli KCCM 80210 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2021 (2) that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli KCCM 80210 does not have an adverse effect on the health of non-ruminant animals, consumer safety or the environment. To be safe for ruminants, the L-tryptophan should be protected against degradation in the rumen. The Authority stated that the additive under assessment is considered a mild eye irritant. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(5)

The Authority considered that L-tryptophan produced by Escherichia coli KCCM 80210 is an efficacious source of the essential amino acid tryptophan for non-ruminant animals; for the supplemental L-tryptophan produced by Escherichia coli KCCM 80210 to be as efficacious in ruminants as in non-ruminants, it should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of L-tryptophan produced by Escherichia coli KCCM 80210 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

(7)

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 (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 March 2021 (2) that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.366, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of that additive, the Authority could neither exclude a risk by inhalation, nor that L-valine might be irritant to skin or eyes, or a dermal sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

(6)

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) 2017/745 requires the Commission to lay down the detailed arrangements necessary for the setting up and maintenance of the European database on medical devices (‘Eudamed’).

(2)

Regulation (EU) 2017/746 of the European Parliament and of the Council (2) requires the Commission to set up, maintain and manage Eudamed, in accordance with the conditions and detailed arrangements established by Regulation (EU) 2017/745.

(3)

As provided for in Regulations (EU) 2017/745 and (EU) No 2017/746, the Commission, competent authorities, authorities responsible for notified bodies, notified bodies, manufacturers, authorised representatives, importers, natural or legal persons referred to in Article 22(1) of Regulation (EU) 2017/745 (system or procedure pack producers) and sponsors of clinical investigations and performance studies should have access to and use Eudamed for the purpose of complying with their obligations and carrying out their tasks under those Regulations. It is, therefore, necessary to provide for the accessibility of Eudamed via a restricted website. In addition, Eudamed should provide the public with adequate information about devices placed on the market, the corresponding certificates issued by notified bodies, the relevant economic operators and clinical investigations. It is, therefore, also necessary to make Eudamed accessible via a public website. Moreover, in order to allow for the exchange of data between Eudamed and national databases, it is necessary to make Eudamed accessible through machine-to-machine data exchange services.

(4)

As regards natural and legal persons that need to be able to access Eudamed via the restricted website, it is necessary to specify the conditions and the procedure for granting such access.

(5)

The Commission has established the European Medical Device Nomenclature (EMDN) as provided for in Regulations (EU) 2017/745 and (EU) No 2017/746. The EMDN should therefore be made available in Eudamed free of charge and used for providing information on medical devices in Eudamed.

(6)

In order to ensure that users of Eudamed receive the support needed when using the database, the Commission should provide them with timely technical and administrative assistance on Eudamed.

(7)

In case of technical unavailability or malfunction of Eudamed, authorised users should still be able to fulfil their obligations. It is therefore necessary to specify alternative mechanisms to be used to exchange data in such events and to lay down contingency rules for such mechanisms.

(8)

Rules on IT security set out in Commission Decision (EU, Euratom) 2017/46 (3) apply to Eudamed. In order for Eudamed to function in a secure manner, protected against threats to the availability, integrity and confidentiality of its functions and data, additional security rules should be laid down.

(9)

In order to mitigate risks and address potential fraudulent use of Eudamed, specific provisions on fraudulent user activity in Eudamed should be laid down.

(10)

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 (4) and delivered an opinion on 9 July 2021.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

(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)

On 29 July 2019, the company MBio, Monaghan Mushrooms (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place vitamin D2 mushroom powder on the Union market as a novel food. The applicant requested vitamin D2 mushroom powder to be used in number of foods intended for the general population. The applicant also requested the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), excluding in food supplements for infants, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), excluding foods for special medical purposes intended for infants. During the application process, the applicant agreed to exclude children under 3 years of age from the request for authorisation of the novel food in food supplements.

(4)

The applicant also submitted a request to the Commission for the protection of proprietary data for a number of original data submitted in support of the application, namely, data concerning the production process (5); compositional data: particle size (6), physico-chemical properties (7), vitamin D analysis (8), nutritional analysis (9), vitamin D2 analysis (10), vitamin D analysis validation (11), stability studies (12), toxicological analysis (13), data concerning tachysterol and lumisterol (14), ergosterol ratio analysis (15), vitamin D ratio analysis (16), data concerning ergosterol (17); specifications of fresh mushrooms (18); data concerning allergenicity (19).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 24 January 2020, requesting it to provide a scientific opinion by carrying out an assessment of the safety of vitamin D2 mushroom powder as a novel food.

(6)

On 24 February 2021, the Authority adopted its scientific opinion on the ‘Safety of Vitamin D2 mushroom powder (Agaricus bisporus) as a novel food pursuant to Regulation (EU) 2015/2283’ (20). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In that opinion, the Authority concluded that vitamin D2 mushroom powder is safe at the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that vitamin D2 mushroom powder under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

A labelling requirement should be provided in order to properly inform the consumers that infants and children under 3 years of age should not consume food supplements containing vitamin D2 mushroom powder.

(9)

In its opinion, the Authority considered that the data concerning the production process and compositional data served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the conclusions on the safety of vitamin D2 mushroom powder could not have been reached without that data.

(10)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to those data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.

(11)

The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.

(12)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data concerning the production process; compositional data: particle size, physico-chemical properties, vitamin D analysis, nutritional analysis, vitamin D2 analysis, vitamin D analysis validation, stability studies, toxicological analysis, data concerning tachysterol and lumisterol, ergosterol ratio analysis, vitamin D ratio analysis, data concerning ergosterol contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place vitamin D2 mushroom powder on the market within the Union during that period.

(13)

However, restricting the authorisation of vitamin D2 mushroom powder and the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such an authorisation under Regulation (EU) 2015/2283.

(14)

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

(15)

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 (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 (2) that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 does not have an adverse effect on animal health, consumers safety or the environment. The Authority also concluded for the additive in question that it was not possible to conclude on the potential for the additive to be toxic if inhaled, an irritant to eyes or a skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of the essential amino acid histidine and efficacious as a flavouring compound.

(5)

The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

(7)

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

(1)

Commission Directive 2006/10/EC (2) included indoxacarb 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 indoxacarb, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2022.

(4)

An application for the renewal of the approval of indoxacarb was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft 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 28 November 2016.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 15 December 2017, the Authority communicated to the Commission its conclusion (6) on whether indoxacarb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The ecotoxicology section of this conclusion was amended in 2018 to clarify the risk assessment for bees according to the relevant European Commission Guidance (SANCO/10329/2002-rev.2). On 15 May 2019, the Commission requested the Authority for an updated peer review concerning the risk to mammals and bees of indoxacarb. On 28 October 2019, the Authority adopted a statement on the updated peer review concerning the risk to mammals and bees posed by the active substance indoxacarb (7) which was reflected in a second update of the Authority’s conclusion on whether indoxacarb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

A critical area of concern was identified by the Authority in relation to the high long-term risk to wild mammals, in particular the long-term risk to small herbivorous mammals.

(10)

Additionally, a high risk to consumers and workers was identified for the representative use in lettuce and a high risk to bees was identified for the representative use in maize, sweet corn and lettuce for seed production.

(11)

Furthermore, several areas of the risk assessment could not be finalised due to insufficient data in the dossier. In particular, the consumer risk assessment could not be finalised due to lack of data on rotational crop metabolism, data regarding the metabolism in poultry, the magnitude of residues in primary and rotational crops and data on the effect of water treatment processes on the nature of residues in drinking water. In addition, the assessment concerning groundwater exposure for soil metabolite IN-U8E24 could not be finalised due to lack of data on soil degradation and adsorption. Similarly, the ecotoxicological risk assessment for several metabolites could not be finalised.

(12)

On 14 November 2018, the applicant informed the Commission of its decision to withdraw from the renewal application the representative use in lettuce.

(13)

The Commission invited the applicant to submit its comments on the conclusion of the Authority, the revised conclusion and the statement. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(14)

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

(15)

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 indoxacarb in accordance with Article 20(1)(b) of that Regulation.

(16)

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

(17)

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

(18)

For plant protection products containing indoxacarb, 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.

(19)

Commission Implementing Regulation (EU) 2021/1449 (8) extended the expiry date of indoxacarb to 31 October 2022 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

(20)

This Regulation does not prevent the submission of a further application for the approval of indoxacarb in accordance with Article 7 of Regulation (EC) No 1107/2009.

(21)

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 Regulation (EU) No 376/2014 Member States and the European Union Aviation Safety Agency (‘the Agency’) are each required to establish a mechanism to independently collect, evaluate, process, analyse and store details of aviation safety occurrences. The competent authorities of the Member States have to draw up occurrence reports on the basis of details of occurrences and store them in a national database. The same obligation exists for the Agency to draw up occurrence reports on the basis of details of occurrences and store them in a database.

(2)

In accordance with Article 9(1) of Regulation (EU) No 376/2014, Member States and the Agency are to participate in an exchange of information by making all information relating to safety stored in their respective reporting databases available through the European Central Repository (ECR).

(3)

Pursuant to Regulation (EU) No 376/2014, occurrence reports are to contain a safety risk classification that is subject to review by the competent authorities of the Member States or the Agency, and are to be transferred into the ECR.To ensure that the occurrence reports contained in the ECR are all classified in a harmonised manner, the competent authorities of the Member States and the Agency should ensure that the classification in those reports is determined in accordance with the common European risk classification scheme (ERCS) as set out in Commission Delegated Regulation (EU) 2020/2034 (2).

(4)

It is now necessary to lay down the arrangements for a harmonised and consistent implementation of the ERCS by the Agency and Member States.

(5)

When occurrence reports contain a risk classification determined by using methodologies other than the ERCS, the competent authorities of the Member States or the Agency should classify the risk of the occurrence concerned in accordance with the ERCS as defined in Commission Delegated Regulation (EU) 2020/2034.

(6)

In cases where the competent authorities of the Member States or the Agency decide to use a conversion procedure to convert the risk classifications referred to in recital 5 into an ERCS classification, and where such methodologies are ARMS-ERC 4x4 or RAT ‘ATM Overall’, the competent authorities of the Member States or the Agency should use the direct conversion procedure provided in this Regulation.

(7)

Where the direct conversion procedure set out in the Annex is not applicable, the competent authorities of the Member States and the Agency should be allowed to use other conversion procedures as long as an equivalent ERCS classification is achieved.

(8)

Continuous monitoring and improvement of the ERCS is necessary to ensure its effective application. It is necessary to lay down detailed rules for such monitoring and improvement and the Agency should assist the Commission in that review and monitoring. For that purpose, Member States should report regularly and within prescribed deadlines to the Agency and the Commission on the use of the ERCS and its assessment.

(9)

The competent authorities of the Member States, and the Agency need to prepare for the application of the ERCS, in particular by adjusting their internal processes and possibly allocating additional resources. However, Article 24(3) of Regulation (EU) No 376/2014 provides that Article 7(2) of that Regulation, which mandates the use of the ERCS by the Member States and the Agency, is to apply once the delegated and implementing acts specifying and developing the ERCS enter into force. Commission Delegated Regulation (EU) 2020/2034 defining the ERCS already entered into force on 31 December 2020. Therefore, it is not possible to delay the applicability of the obligation to use the ERCS beyond the date of the entry into force of this Regulation. Moreover, for the purposes of the annual safety review published by the Agency in accordance with Article 72(7) of Regulation (EU) 2018/1139 of the European Parliament and of the Council (3), it is essential that occurrence reports uploaded to the ECR within a 1 year period are scored in a harmonised way. The obligation to classify the occurrences in accordance with the ERCS should start to apply as of the date of entry into force of this Regulation. Therefore, this Regulation should enter into force on 1 January 2023.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127 of Regulation (EU) 2018/1139,

(1)

On 20 June 2018, the Commission adopted Implementing Regulation (EU) 2018/886 (2) on certain commercial policy measures concerning certain products originating in the United States of America that provides for the application of additional customs duties on imports into the Union of a number of products originating in the United States as follows:

(2)

On 7 April 2020, the Commission adopted Implementing Regulation (EU) 2020/502 (3) that provides for the application of additional customs duties on imports into the Union of certain products originating in the United States, as follows:

(3)

On 31 May 2021, following the EU-US Joint Statement published on 17 May 2021, the Commission adopted Implementing Regulation (EU) 2021/866 (4) on commercial policy measures concerning certain products originating in the United States of America, which suspended the application of the additional ad valorem duties on products listed in Annex II to Implementing Regulation (EU) 2018/886 until 30 November 2021.

(4)

The Commission, on behalf of the Union, may amend Implementing Regulations (EU) 2018/886 (5) and (EU) 2020/502 (6), should it deem that appropriate, to account for any modification of or amendment to the United States’ safeguard measures.

(5)

On 31 October 2021, the United States announced the following amendments to their respective safeguard measures, to take effect from 1 January 2022:

(6)

Accordingly, the Union should suspend the application of the additional ad valorem duties imposed by Implementing Regulations (EU) 2018/886 and (EU) No 2020/502 for a period until 31 December 2023. The suspension should take place as follows:

(7)

This suspension would allow the Union and the United States to significantly advance their ongoing cooperation, including with a view of eliminating the respective tariffs. However, it should be noted that the application of the exclusions from the US measures would last only until 31 December 2023. Such exclusions granted to importers in the United States when importing Union products significantly reduce the negative impact of the United States’ safeguard measures. Therefore, a suspension until 31 December 2023 is considered as a sufficient and reasonable period and takes due account of the United States’ announcements of 31 October 2021.

(8)

Article 4(2)(c) of Regulation (EU) No 654/2014 requires the Union’s action to be substantially equivalent to the level of concessions or other obligations affected by the safeguard measures of the third country.

(9)

The Commission should keep the suspension under review in light of new developments, for instance developments that could deteriorate the situation for the Union exports that remain subject to the safeguard measures of the United States, including any impediments affecting the Union exports. The Commission may amend this Regulation to account for such developments, any modification of or amendment to the United States’ safeguard measures.

(10)

The suspension is without prejudice to the Union’s position that the safeguard measures by the United States remain incompatible with the WTO Agreement.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Trade Barriers Committee, established by Regulation (EU) 2015/1843 of the European Parliament and of the Council (7),