(1)

Regulation (EU) 2017/625 lays down general rules for the performance of official controls to verify compliance with rules aimed at preventing, eliminating or reducing, to acceptable levels, the risks to which humans and animals are exposed either directly or through the environment.

(2)

In particular, Regulation (EU) 2017/625 lays down general conditions for the entry into the Union of animals and goods from third countries or regions thereof, including food intended for human consumption. Article 129 of Regulation (EU) 2017/625 empowers the Commission to recognise that measures applied by third countries, or regions thereof, are equivalent to the requirements laid down in certain rules referred to in Article 1(2) of that Regulation, if the third countries offer objective proof in this respect. It also empowers the Commission to set out the conditions governing the entry into the Union of such animals and goods from such third countries or regions thereof, in particular with regard to the nature and content of the official certificates or attestations that are to accompany those commodities.

(3)

In accordance with Commission Implementing Regulation (EU) 2020/1641 (3), the measures applied in the States of Massachusetts and Washington of the United States for the protection of public health in relation to the production and placing on the market of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

(4)

Implementing Regulation (EU) 2020/1641 establishes a model official certificate for imports from the United States of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption. The model official certificate requires an official inspector to certify that the measures applied to the production and placing on the market of those commodities are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

(5)

In line with the measures agreed with the department of the Food and Drug Administration of the United States responsible for the export to the Union of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, the model official certificate established in Implementing Regulation (EU) 2020/1641 should be adapted to the appropriate format for the export to the Union of those commodities. In particular, the model official certificate should inform about the date of departure of the consignments. Furthermore, information should be provided on whether the commodities are certified for human consumption or for the final consumer.

(6)

In addition to the public health requirements of the model official certificate established in Implementing Regulation (EU) 2020/1641, live bivalve molluscs of species listed in Commission Implementing Regulation (EU) 2018/1882 (4), which are intended for human consumption, and products of animal origin from those molluscs, which are intended for further processing in the Union before human consumption, should enter the Union only if they are accompanied by an official certificate that includes the appropriate animal health attestations. Consequently, in order to fulfil animal health requirements that provide guarantees equivalent to those provided for in Union legislation, the model official certificate should include the general animal health requirements for entry into the Union, as set out in Article 6(1), points (a) and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (5), and the specific animal health requirements for entry into the Union of those commodities as set out in Article 167, points (a), (c)(ii), (c)(iii) and (d), and Article 169(1) and (2) of Delegated Regulation (EU) 2020/692.

(7)

Implementing Regulation (EU) 2020/1641 should therefore be amended accordingly.

(8)

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 Article 7(1) of Regulation (EC) No 1107/2009, Danstar Ferment AG and Comercial Quimica Masso submitted to France, on 26 June 2017, an application for the approval of the active substance Bacillus amyloliquefaciens strain IT-45.

(2)

In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicants, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 1 December 2017 of the admissibility of the application.

(3)

On 15 May 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, concluding that the active substance Bacillus amyloliquefaciens strain IT-45 could be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority also set a time limit for the applicants to supply additional information to the Member States, the Commission and the Authority

(5)

In its Conclusion, communicated to the applicants, the Member States and the Commission, following a peer review of the pesticide risk assessment pursuant to Article 12 (2) of Regulation (EC) No 1107/2009, the Authority held that the active substance Bacillus amyloliquefaciens strain IT-45 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public (2).

(6)

On 21-22 October 2021, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed its review report on the active substance Bacillus amyloliquefaciens strain IT-45 and a draft of this Regulation regarding Bacillus amyloliquefaciens strain IT-45.

(7)

The applicants were given the possibility to submit comments on the review report.

(8)

It has been established with respect to one representative use of at least one plant protection product containing the active substance, as examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(9)

Since the Commission considers that Bacillus amyloliquefaciens strain IT-45 is a low-risk active substance, pursuant to Article 22 of Regulation (EC) No 1107/2009, and since plant protection products containing that substance may be expected to pose only a low risk to human and animal health and the environment, it may be approved for up to 15 years. No critical area of concerns were identified for humans, animals and the environment.

(10)

Bacillus amyloliquefaciens strain IT-45 is a microorganism, which also fulfils the conditions established by Article 22 (2) of Regulation (EC) No 1107/2009, in conjunction with point 5.2. of Annex II to that Regulation. It is therefore appropriate to approve Bacillus amyloliquefaciens strain IT-45 as a low-risk substance.

(11)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should therefore be amended accordingly.

(12)

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) 2017/625 lays down general rules for official controls performed by the competent authority for the verification of compliance with rules in a number of areas, including animal health, on a risk basis and with appropriate frequencies. That Regulation also lays down methods and techniques for official controls, which include, among others, inspections of premises, animals and goods under the control of operators.

(2)

Regulation (EU) 2017/625 provides for uniform practical arrangements for the performance of official controls regarding uniform minimum frequencies of official controls to be laid down, where necessary to respond to specific hazards and risks to animal health and to verify compliance with disease prevention and control measures.

(3)

Before the entry into application of Regulation (EU) 2016/429 of the European Parliament and of the Council (2), a number of legal acts on animal health laid down rules for minimum frequencies for official controls, in particular inspections. Regulation (EU) 2016/429 repealed those legal acts with effect from 21 April 2021.

(4)

Commission Delegated Regulation (EU) 2019/2035 (3) lays down requirements for approval, among others, of hatcheries and establishments keeping poultry, establishments for assembly operations for ungulates and poultry, assembly centres of dogs, cats and ferrets, animal shelters for dogs, cats and ferrets, control posts, environmentally isolated production establishments for bumble bees, quarantine establishments and confined establishments of terrestrial animals.

(5)

Commission Delegated Regulation (EU) 2020/686 (4) lays down requirements for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals may be moved to another Member State.

(6)

Commission Delegated Regulation (EU) 2020/691 (5) lays down requirements for approval of certain aquaculture establishments and groups of aquaculture establishments keeping aquatic animals posing a significant animal health risk.

(7)

It is important that the competent authority verifies by way of regular official controls, in particular by way of inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625, that the animals and germinal products are continued to be kept and produced under the uniform approval conditions for establishments, that are intended to mitigate risks and hazards associated with diseases listed in Regulation (EU) 2016/429 and with emerging diseases. To respond to those uniform hazards and risks to human and animal health posed by those diseases, uniform minimum frequencies for inspections in certain approved establishments should be laid down in this Regulation.

(8)

For approved germinal product establishments any uniform minimum frequency for inspections should take into account the non-seasonal nature of collecting semen of bovine and porcine animals.

(9)

Any uniform minimum frequency for inspections in certain approved aquaculture establishments and approved groups of aquaculture establishments should take into account the risk ranking of that establishment or group of establishments in accordance with Commission Delegated Regulation (EU) 2020/689 (6).

(10)

As regards identification and registration of certain animals, Commission Regulations (EC) No 1082/2003 (7) and Commission Regulation (EC) No 1505/2006 (8) lay down the minimum level of controls or checks to be carried out in establishments keeping bovine, ovine and caprine animals each year as well as the number of animals to be inspected in each of those establishment.

(11)

Delegated Regulation (EU) 2019/2035 also lays down detailed requirements for the identification and registration of bovine, ovine and caprine animals to ensure their traceability.

(12)

Bovine, ovine or caprine animals that are not identified or registered in accordance with the requirements laid down in Delegated Regulation (EU) 2019/2035 may play a role in spreading diseases listed in Regulation (EU) 2016/429 and in emerging diseases. To mitigate that uniform hazard and risk to human and animal health, to regularly verify compliance of operators with the requirements laid down in Delegated Regulation (EU) 2019/2035 and to ensure the uniform implementation of Regulation (EU) 2017/625, uniform minimum frequencies for inspections during the performance of official controls on identification and registration of bovine, ovine, and caprine animals should be laid down.

(13)

Delegated Regulation (EU) 2019/2035 did not explicitly repeal Regulations (EC) No 1082/2003 and (EC) No 1505/2006. To ensure legal certainty, this Regulation should repeal those Regulations.

(14)

The rules laid down in this Regulation should apply to the United Kingdom in respect of Northern Ireland, in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community in conjunction with Annex 2 to that Protocol.

(15)

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

(a)

approved establishments for kept terrestrial animals and hatching eggs referred to in Article 1(1), point (a), of Delegated Regulation (EU) 2019/2035;

(b)

approved germinal product establishments referred to in Article 3 of Delegated Regulation (EU) 2020/686;

(c)

certain aquaculture establishments approved pursuant to Article 176(1), of Regulation (EU) 2016/429 and groups of aquaculture establishments approved pursuant to Article 177, of that Regulation;

(d)

registered establishments for kept terrestrial animals referred to in Article 1(1) point (a), of Delegated Regulation (EU) 2019/2035 that keep bovine, ovine or caprine animals.

(a)

‘establishment’ as defined in Article 4, point (27), of Regulation (EU) 2016/429;

(b)

‘hatchery’ as defined in Article 4, point (47), of Regulation (EU) 2016/429;

(c)

‘assembly operation’ as defined in Article 4, point (49), of Regulation (EU) 2016/429;

(d)

‘assembly centre of dogs, cats and ferrets’ as defined in Article 2, point (7), of Delegated Regulation (EU) 2019/2035;

(e)

‘animal shelter’ as defined in Article 2, point (8), of Delegated Regulation (EU) 2019/2035;

(f)

‘control post’ as defined in Article 2, point (9), of Delegated Regulation (EU) 2019/2035;

(g)

‘environmentally isolated production establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2019/2035;

(h)

‘approved quarantine establishment’ as defined in Article 3, point (9), of Delegated Regulation (EU) 2020/688;

(i)

‘confined establishment’ as defined in Article 4, point (48), of Regulation (EU) 2016/429;

(j)

‘approved germinal product establishment’ as defined in Article 2, point (2), of Delegated Regulation (EU) 2020/686;

(k)

‘approved aquaculture establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2020/990;

(l)

‘approved group of aquaculture establishments’ as defined in Article 2, point (11), of Delegated Regulation (EU) 2020/990.

(a)

hatcheries and establishments keeping poultry;

(b)

establishments for assembly operations for ungulates and poultry;

(c)

assembly centres of dogs, cats and ferrets;

(d)

animal shelters for dogs, cats and ferrets;

(e)

control posts;

(f)

environmentally isolated production establishments for bumble bees;

(g)

approved quarantine establishments;

(h)

confined establishments.

(a)

at least twice every calendar year, semen collection centres for bovine and porcine animals;

(b)

at least once every calendar year:

(a)

high-risk establishments shall be inspected at least once every calendar year;

(b)

medium-risk establishments shall be inspected at least once every two calendar years;

(c)

low-risk establishments shall be inspected at least once every three calendar years.

(1)

Directive (EU) 2019/904 lays down an obligation on Member States to take measures to achieve an ambitious and sustained reduction in the consumption of the single-use plastic products listed in Part A of the Annex to that Directive (‘single-use plastic products’). The Commission is to lay down the methodology for the calculation and verification of that consumption reduction.

(2)

Directive (EU) 2019/904 also sets out an obligation on Member States to report to the Commission data on the single-use plastic products that have been placed on the market each year and information on the measures taken in order to reduce the consumption of such products, including a quality check report. The Commission is to lay down the format for that reporting.

(3)

Directive (EU) 2019/904 gives Member States a wide margin of discretion in deciding which measures to adopt in order to achieve an ambitious and sustained reduction in the consumption of single-use plastic products. Those measures may vary depending on the environmental impact of the single-use plastic products over their life cycle, including when they become litter, and they shall be proportionate and non-discriminatory.

(4)

Measuring consumption reduction on the basis of the weight of plastic content in single-use plastic products placed on the market is an appropriate measurement method since it reflects the environmental impact of such products in terms of environmental pollution by plastic littering. That method also takes into consideration the measurement methods and reporting formats for packaging and packaging waste set out in Commission Decision 2005/270/EC (2) which are based on weight and material.

(5)

Measuring consumption reduction on the basis of a number of single-use plastic products placed on the market is also an appropriate methodology to monitor the impact, at a product level, of consumption reduction on waste prevention and therefore the potential reduction of plastic pollution in the environment.

(6)

Given the wide margin of discretion given to Member States by Article 4 of Directive (EU) 2019/904, Member States should be given the choice between calculating the consumption reduction based on either the total weight of the plastic contained in the single-use plastic products placed on the market or the number of such products placed on the market. Since both methodologies provide suitable data to monitor consumption trends and the impact of the measures taken on prevention of waste generation as well as on substitution of the products with alternatives that are re-usable or do not contain plastic, Member States should be given the option to choose from those two methodologies the methodology that is compatible with their consumption reduction policies and measures taken under Article 4 of Directive (EU) 2019/904.

(7)

Where, in a certain Member State, the number or the weight of single-use plastic products placed on the market is not representative for the consumption of single-use plastic products in that Member State due to significant movements within the Union of single-use plastic products at wholesale level, that Member State should be allowed to adjust the weight or number in order to take account of such movements.

(8)

Where a Member State chooses to apply the weight-based methodology, it should also report data on the total weight of single-use plastic products partly made of plastic that have been placed on the market, as such information contributes to data comparability and makes it possible to obtain a broader overview of the impact of the consumption reduction requirement set out in Directive (EU) 2019/904.

(9)

In order to facilitate the Commission’s overview of the measures taken by the Member States to achieve a reduction in the consumption of the single-use plastic products in accordance with Directive (EU) 2019/904, the reporting format should contain an indicative list of different categories of such measures. Member States are, however, required to report all the measures undertaken even if not explicitly mentioned in the indicative list.

(10)

In order to ensure accuracy and verification of data, the reporting format should ensure that all the parameters relevant for the calculation and verification of the reduction in the consumption of single-use plastic products, for the reporting of data on such products placed on the market and for the reporting of measures taken to achieve the consumption reduction are identified and should set out the methodology to be applied for the calculation and verification of the consumption reduction.

(11)

The methodology for the calculation and verification of the reduction in the consumption of single-use plastic products, referred to in Article 4(2) of Directive (EU) 2019/904, and the formats for reporting data on the single-use plastic products placed on the market as well as information on the measures taken by the Member States, referred to in Article 13(4) of that Directive, are closely linked in view of their subject-matter. It is therefore appropriate to adopt this act on the basis of both of those provisions in order to ensure coherence between the rules on calculation, verification and reporting of the reduction in the consumption of single-use plastic products and to facilitate access to those rules.

(12)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 39 of Directive 2008/98/EC of the European Parliament and of the Council (3),