(1)

On 6 December 2018, the Council authorised the Commission to open negotiations pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (‘GATT’) 1994 on an adequate compensation following Switzerland’s decision to modify the tariff concession in Schedule LIX — Switzerland-Liechtenstein for meat not further prepared than seasoned.

(2)

The negotiations have been concluded and an Agreement in the form of an Exchange of Letters between the European Union and the Swiss Confederation in the context of negotiations under Article XXVIII of the GATT 1994 on the modification of Switzerland’s WTO concessions with regard to seasoned meat (hereinafter referred to as ‘the Agreement’) was initialled on 17 July 2019.

(3)

This Decision relates exclusively to Union trade policy and implements an agreement following negotiations in the framework of the Article XXVIII of the GATT 1994, a Union right under the Agreement establishing the World Trade Organization (WTO).

(4)

The Agreement should therefore be signed,

(1)

The Romanian language version of Commission Delegated Regulation (EU) 2015/35 (2) contains an error in Annex XVII, Part F, point 2(g) as regards the inverse meaning of a sentence.

(2)

Delegated Regulation (EU) 2015/35 should therefore be corrected accordingly. The other language versions are not affected,

(1)

Pursuant to Article 32(1) of Regulation (EU) No 1286/2014, management companies as defined in Article 2(1)(b) of Directive 2009/65/EC of the European Parliament and of the Council (2), investment companies as referred to in Article 27 thereof and persons advising on, or selling, units of UCITS as referred to in Article 1(2) thereof are exempt from the obligations under that Regulation until 31 December 2019. When a Member State applies rules on the format and content of the key information document, as laid down in Articles 78 to 81 of Directive 2009/65/EC, to non-UCITS funds offered to retail investors, the exemption laid down in Article 32(1) of Regulation (EU) No 1286/2014 applies to management companies, investment companies and persons advising on, or selling, units of such funds to retail investors. To provide those funds with a consistent transitional legal regime, the third paragraph of Article 18 of Commission Delegated Regulation (EU) 2017/653 (3) allows manufacturers of packaged retail and insurance-based investment products (‘PRIIP manufacturers’) to continue using such documents drawn up in accordance with those Articles until 31 December 2019, where at least one of the underlying investment options is a UCITS or non-UCITS fund.

(2)

Regulation (EU) No 1286/2014 has been amended to extend the transitional arrangements referred to in Article 32 thereof until 31 December 2021 (4). In order to enable PRIIP manufacturers to determine their obligations with certainty, the date set out in the third paragraph of Article 18 of Delegated Regulation (EU) 2017/653 should be changed accordingly.

(3)

Delegated Regulation (EU) 2017/653 should therefore be amended accordingly.

(4)

This Regulation is based on draft regulatory technical standards submitted to the Commission by the European Banking Authority, the European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority (the ‘European Supervisory Authorities’).

(5)

The European Supervisory Authorities have not conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, nor analysed potential related costs and benefits, as an impact assessment has already been produced for regulatory technical standards laid down in Delegated Regulation (EU) 2017/653. This Regulation neither alters the substance of Delegated Regulation (EU) 2017/653 nor creates new obligations for PRIIPs manufacturers or persons advising on or selling PRIIPs, including those referred to in Article 32 of Regulation (EU) No 1286/2014. The European Supervisory Authorities have requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (5), the Insurance and Reinsurance Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (6) and the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7),

(1)

With a view to simplifying the use of the European Regional Development Fund (‘ERDF’), the European Social Fund (‘ESF’), the Cohesion Fund, the European Agricultural Fund for Rural Development (‘EAFRD’) and the European Maritime and Fisheries Fund (‘EMFF’) financing and reducing both administrative burden and the risk of error, it is appropriate to lay down a flat rate for the reimbursement of costs to one or more beneficiaries of operations supported under technical assistance, without the need to justify the rate. This includes cases where the managing authority or the paying agency or another body is implementing technical assistance operations.

(2)

The level of the flat rate is based on the ceilings and the actual allocation for technical assistance in programmes as well as absorption data from past programming periods. The use of the flat-rate reimbursement method does not have an impact on the financial allocation for technical assistance in the adopted programmes. It may also be used in programmes supported by more than one fund even if the technical assistance priority receives support from a different fund than the one providing support for priorities other than technical assistance in the same programme.

(3)

In addition, in order to facilitate financial management within the existing programming arrangements, it should be specified for the ERDF, the ESF and the Cohesion Fund as well as for the EMFF that the basis for the application of the rate is the eligible expenditure under priority axes other than the technical assistance priority axis of the programme in which this flat-rate reimbursement method is used. Therefore, this flat rate is not to be used where a programme covers exclusively technical assistance. Furthermore, for the aforementioned Funds there is no requirement to amend the programme where this flat-rate reimbursement method is used.

(4)

It is necessary to specify that the basis for the application of the flat rate is the eligible expenditure for which the managing authority or the relevant control body has completed the management verifications or, in the case of the EAFRD, the relevant administrative checks.

(5)

In order to avoid the risk of double-financing where Member States make use of this option, the flat-rate financing should only be applied to expenditure that has been subject to management verification after this Regulation has entered into force and then until the end of the eligibility period. For the same reason, for the EAFRD, the flat-rate financing should only be applied to expenditure which has been subject to administrative checks as from the beginning of the agricultural financial year, as provided for in Article 39 of Regulation EU (No) 1306/2013 of the European Parliament and of the Council (2), starting on 16 October 2019 or from any subsequent agricultural financial year and then until the end of the eligibility period. In order to ensure sound financial management, Member States need to make sure that the amounts reimbursed in form of flat-rate financing are calculated based on expenditure of non-technical assistance projects, which is legal and regular.

(6)

The flat-rate financing mechanism can only be used in accounting years which at the date of entry into force of this Regulation have not yet been closed. In order to allow for checks in the context of Article 9 and Article 47 of Regulation (EU) No 1306/2013 of the basis for the calculation of the flat-rate financing, for the EAFRD the flat-rate financing mechanism may only be used for expenditure as from the beginning of the agricultural financial year starting on 16 October 2019 or from any subsequent agricultural financial year.

(7)

In order to allow for prompt application of the measures provided for in this Regulation, in view of making use of it early enough in the current accounting year, and in the case of the EAFRD in the agricultural financial year starting on 16 October 2019, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,

(1)

Since 2012, emission allowances are auctioned in accordance with Commission Regulation (EU) No 1031/2010 (2). The auctioning of allowances is conducted by a common auction platform for 25 Member States and three EEA EFTA states and by a small number of opt-out platforms.

(2)

Directive 2003/87/EC has been amended by Directive (EU) 2018/410 of the European Parliament and of the Council (3) to enhance cost-effective emission reductions and low-carbon investments through the system for greenhouse gas emission allowance trading within the Union (‘EU ETS’) as from 2021. The auctioning of allowances remained the general rule for allocation of allowances whereby the share of allowances to be auctioned should be 57 % of the total quantity of allowances.

(3)

It is appropriate to incorporate the new elements introduced by Directive (EU) 2018/410, related to the determination of the annual auction volume, into Regulation (EU) No 1031/2010. In particular, it is necessary to take into account the possibility to reduce the auction volume by up to 3 % of the total quantity of allowances to increase the amount available for free allocation (free allocation buffer). Furthermore, the revised Directive 2003/87/EC allows for changes to be made to the annual auction volumes due to: voluntary cancellation of allowances by the Member States in the event of closure of electricity generation capacity; the reintroduction into the EU ETS of installations that emit less than 2 500 tonnes of carbon dioxide; and the flexibility established between the ETS and non-ETS sectors to facilitate the achievement of Member States national reduction targets in non-ETS sectors as provided for by Article 6 of Regulation (EU) 2018/842 of the European Parliament and of the Council (4).

(4)

Directive 2003/87/EC establishes the Modernisation Fund to improve energy efficiency and modernise the energy systems of certain Member States and the Innovation Fund to support investments in innovative technologies. Both funds are financed through the auctioning of allowances on the common auction platform by the European Investment Bank (‘EIB’). To this end, the EIB should become the auctioneer for the two funds without becoming part of the joint procurement procedure for the common auction platform. The relevant volumes of allowances should be auctioned at the same auctions as the volumes auctioned by the Member States and the EEA EFTA states participating in the common auction platform.

(5)

In view of establishing the Modernisation Fund, Directive 2003/87/EC provides that 2 % of the total quantity of allowances are to be auctioned and, in addition, the eligible Member States may add to this fund allowances under Articles 10(2)(b) and 10c of Directive 2003/87/EC. The EIB is required to ensure that those allowances are auctioned in accordance with the principles and modalities of the auctioning process, where the equal distribution of auction volumes is a key element.

(6)

To ensure the availability of funds for innovation in low carbon technologies and the proper functioning of the carbon market, the volumes of the Innovation Fund should in principle be auctioned in equal annual volumes. However, the Commission should review in two-year intervals the distribution of allowances to be auctioned for the Innovation Fund taking into account the results of each call for proposals. The first review should be carried out no later than by 30 June 2022.

(7)

With a view to enable that a Member State can cancel allowances from its auction volumes in the event of closure of electricity generation capacity in its territory, a notification procedure should be established. The Member State concerned should notify the Commission of its intention to cancel allowances using a uniform template providing evidence and information about the closed installation, the intended volume and timing of the cancellation. To preserve the functioning of the market stability reserve (‘MSR’) established by Decision (EU) 2015/1814 of the European Parliament and of the Council (5), the volume of the cancellation should be deducted from the auction volumes of the Member State only after the MSR adjustments are made for the respective year. To ensure transparency, the Commission should publish the information provided by the Member States in accordance with the template, except where this information is protected for reasons of confidentiality.

(8)

In order to reinforce the integrity of the carbon market, since 2018, allowances are classified as financial instruments by Directive 2014/65/EU of the European Parliament and of the Council (6). Previously, Directive 2004/39/EC of the European Parliament and of the Council (7) recognised only derivatives of allowances as financial instruments. The new classification brings the secondary market spot trade in allowances in the scope of, inter alia, Directive 2014/65/EU, Regulation (EU) No 596/2014 of the European Parliament and of the Council (8) and Regulation (EU) No 600/2014 of the European Parliament and of the Council (9). However, the process of auctioning of allowances (primary market) is only in the scope of Regulation (EU) No 596/2014.

(9)

To align the auctioning of allowances with the new financial market regulatory regime, the system established for monitoring and reporting of auctions should be revised. Because the scope of Regulation (EU) No 596/2014 has been extended and applies also to the auctioning of allowances, the functions of monitoring and preventing market abuse with respect to auctions are a responsibility of the competent national authorities. The competent national authorities are required by Regulation (EU) No 596/2014 to actively detect and investigate occurrences of market abuse. The necessary auction monitoring functions should be carried out by the auction platforms, the Commission, the Member States and the competent national authorities and the provisions laying down an obligation to appoint an auction monitor should be deleted. Further, as Regulation (EU) No 596/2014 applies directly to auctions, the specific market abuse provisions of Regulation (EU) No 1031/2010 have become redundant and should be deleted.

(10)

To provide the necessary reporting data to the competent national authorities responsible for surveillance of market abuse in a cost-efficient and proportionate manner, Regulation (EU) No 1031/2010 should mirror the necessary transaction reporting obligations set out in Regulation (EU) No 600/2014 and make them applicable to auction platforms with respect to reporting on auction transactions. This is necessary since Regulation (EU) No 596/2014 that is now applicable to auctions, does not establish a self-standing transaction reporting mechanism, but relies on data collection under Regulation (EU) No 600/2014.

(11)

It is essential to ensure a competitive procurement process for auction platforms and that the relevant criteria are set accordingly. In relation to the fees to be paid by the successful bidders, it should be possible to increase the current maximum fee level in a limited manner where this is foreseen by the procurement procedure and the annual auction volumes are reduced by more than 200 million allowances due to the operation of the market stability reserve.

(12)

The public procurement for the common auction platform may provide for expanding the selection criteria also to regulated markets in energy products which have not yet established a secondary market in emission allowances. In case such regulated market is selected to become an auction platform, it should be required to put it in place at least 60 trading days prior to the first auction. This is necessary to establish the price of the secondary market at the time of the auctions (‘reserve price’) for the cases of cancellation of auctions, and the bidder’s fees, which are linked to the comparable fee paid in the secondary market. In addition, the Commission and the participating Member States should be able to extend the current five years maximum duration of the contracts to seven years in accordance with the provisions of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (10) (‘Financial Regulation’) in circumstances which would be difficult to foresee by a diligent contracting authority. In order to verify the market conditions and to prepare the new procurements during the contract duration, the Commission should be able to undertake preliminary market consultation in accordance with the Financial Regulation.

(13)

To simplify the auction process, the setting of the annual auction volumes should be made more flexible in case changes up to 50 000 allowances are needed. Any change below that threshold should not lead to changing the auction volume of the subsequent year, unless a Member State explicitly requests so. Furthermore, the procedure for the determination and publication of auction calendars should be simplified in the sense that the Commission would no longer provide an opinion thereon. However, the auction calendar should be published after the Commission takes an internal decision on the auction table corresponding to the auction calendar under the delegated acts adopted pursuant to Article 19(3) of Directive 2003/87/EC.

(14)

To simplify the reappointment of opt-out platforms, an amendment to Annex III to Regulation (EU) No 1031/2010 should be required only for the listing of new entities as opt-out platforms, or for a re-listing under changed conditions. Thus, in case the same opt-out platform is appointed by its Member State under the same conditions, its listing should be prolonged under the same terms and conditions as the initial listing without an amendment to Annex III to Regulation (EU) No 1031/2010. This should be subject to a confirmation from the Member State and the Commission that the requirements of this Regulation and the objectives of Article 10(4) of Directive 2003/87/EC are satisfied.

(15)

To avoid accumulation of cancelled volumes in case several auctions are cancelled, it should be made possible that the cancelled volumes are distributed evenly over the next auctions that do not include cancelled volumes from previously cancelled auctions.

(16)

Regulation (EU) No 1031/2010 should therefore be amended accordingly,

(1)

Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited.

(2)

Data have been received from competent authorities and concerned feed business operators indicating that the general maximum level of 2 mg/kg for arsenic in feed materials of plant origin, is not achievable in the specific feed materials leonardite and peat. It is therefore appropriate to increase the maximum level for total arsenic in these feed materials to ensure the supply. The increase does not adversely affect the animal or public health as the maximum level laid down for arsenic in complementary feed and complete feed remains unchanged.

(3)

Data have been received from concerned feed business operators indicating that the general maximum level of 30 mg/kg for arsenic in feed additives belonging to the functional group of compounds of trace elements is not achievable for the trace element dimanganese chloride trihydroxide. It is therefore appropriate to increase the maximum level for arsenic in dimanganese chloride trihydroxide,, based on the data obtained by the analytical method Inductively Coupled Plasma Mass Spectrometry (ICP-MS). The European Reference Laboratory for metals and nitrogenous compounds has confirmed that this method provides the correct results as regards the presence of arsenic in trace elements. This increase does not adversely affect the animal or public health as the maximum level laid down for arsenic in complementary feed and complete feed remains unchanged.

(4)

The Joint Research Centre of the European Commission has examined in cooperation with the concerned parties certain findings concerning fluorine in calcareous marine algae. That examination has established that the background presence of fluorine in calcareous marine algae in some instances exceeds the maximum level laid down for fluorine in calcareous marine algae. It is therefore appropriate to increase the maximum level for fluorine in calcareous marine algae from 1 000 mg/kg to 1 250 mg/kg. This increase does not adversely affect the animal or public health as the maximum level established for fluorine in complementary feed and complete feed remains unchanged.

(5)

Commission Regulation (EU) 2017/2229 (2) amended Annex I to Directive 2002/32/EC as regards, inter alia, lead. For reasons of clarity the whole entry for lead was replaced. In this replacement, in the list of feed materials for which the maximum level of 15 mg/kg is applicable, the feed material calcareous marine shells was erroneously omitted. Regulation (EU) 2017/2229 established also a new maximum level for lead in dicopper oxide. However, the International Union of Pure and Applied Chemistry (IUPAC) name of the additive is copper(I) oxide. In line with the European Food Safety Authority’s (‘EFSA’) recommendation in its opinion on cupric oxide (3) the additive should be named copper(I) oxide, which was not done in the English, Italian and Slovak language versions of the Regulation. Those errors should be corrected.

(6)

Certain feed materials belonging to the category of ‘fish, other aquatic animals and products derived thereof’ are placed on the market as canned wet feed material for direct feeding of dogs and cats. As this canned wet feed material replaces the compound feed, it is therefore appropriate to apply the same maximum level of mercury to this canned wet feed material as the maximum level applicable to compound feed as this change does not adversely affect the animal health.

(7)

EFSA adopted a scientific statement on the presence of free gossypol in whole cottonseed (4). It concluded that an update to the Scientific opinion as regards the animal health risks of the presence of gossypol as an undesirable substance in animal feed was not necessary,. Taking into account the occurrence data referred to in that statement, it is appropriate to establish a higher maximum level for free gossypol in the feed material cottonseed. This increase does not adversely affect the animal health as the maximum level laid down for free gossypol in complete feed remains unchanged.

(8)

Directive 2002/32/EC establishes a maximum level for dioxins, sum of dioxins and dioxin-like PCBs and non-dioxin-like PCBs only in certain feed additives belonging to the functional groups of binders and anti-caking agents. However, recent findings notified through the Rapid Alert System for Food and Feed show high levels of dioxins and dioxin-like PCBs, in other feed additives belonging to that functional group. It is therefore appropriate to establish the maximum level for dioxins and PCBs to all feed additives belonging to the functional groups of binders and anti-caking agents. Furthermore, those maximum levels should also apply where the same feed additives are authorised in the functional groups ‘Substances for the control of radionuclide contamination’ and ‘Substances for reduction of the contamination of feed by mycotoxins’.

(9)

Directive 2002/32/EC should therefore be amended accordingly.

(10)

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 Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants in foodstuffs, including for erucic acid in certain foodstuffs.

(2)

On 21 September 2016, the Scientific Panel on Contaminants in the Food Chain (CONTAM) of the European Food Safety Authority (EFSA) adopted a scientific opinion on erucic acid in feed and food (3). EFSA established a tolerable daily intake (TDI) of 7 mg/kg body weight (bw) per day for erucic acid. The highest dietary exposure levels were observed for infants and other children with exposure levels above the TDI. This may indicate a risk for young individuals with high erucic acid exposure.

(3)

Data on the presence of erucic acid in vegetable oils and fats indicate that for most vegetable oils and fats, lower levels can be achieved by applying good practices, e.g. by using varieties low in erucic acid. Therefore, it is appropriate to lower the maximum level for vegetable oils, with the exception of camelina oil, mustard oil and borage oil, to the level established by Codex Alimentarius for low-erucic acid rapeseed oil (4).

(4)

For camelina oil, mustard oil and borage oil, evidence has been provided demonstrating that it is not possible to achieve lower levels by applying good practices as for these species there are no varieties of which the vegetable oils extracted from these plants contain levels of erucic acid lower than the maximum level proposed for the other vegetable oils. Therefore and given that these oils are of less significance for the human exposure than other vegetable oils, the maximum level for erucic acid in camelina oil, mustard oil and borage oil should remain the same. Furthermore, in order to avoid the closure of small and micro size enterprises in certain Member States, it is appropriate to exempt mustard oil produced and consumed locally in small quantities of the application of the maximum level, with acceptance of the competent authority.

(5)

Given that the maximum level for vegetable oils and fats applies also to vegetable oils used as ingredient in food, there is no need to establish a maximum level for erucic acid in foods containing added vegetable oils and fats.

(6)

Given the high concentration of erucic acid in mustard there is a risk of significant exposure to erucic acid through consumption of mustard. Therefore, it is appropriate to establish a maximum level for erucic acid in mustard.

(7)

A maximum level for erucic acid in infant formulae and follow-on formulae has already been established by Commission Delegated Regulation (EU) 2016/127 (5). For reasons of clarity, the maximum level for erucic acid in infant formulae and follow-on formulae established by Regulation (EC) No 1881/2006 should be deleted.

(8)

In Commission Regulation (EU) 2017/1237 (6), no unit of measurement is set for the maximum level for hydrocyanic acid. It is therefore appropriate to correct this error in order to provide legal certainty.

(9)

Regulation (EC) No 1881/2006 should therefore be amended accordingly.

(10)

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

(1)

Where necessary for the purpose of official controls of food of animal origin, the Commission may establish reference values (‘reference points for action’) for residues of pharmacologically active substances in food of animal origin, for which no maximum residue limit has been laid down. Reference points for action should apply to food of animal origin imported from third countries and to food of animal origin produced in the Union.

(2)

Following a request from the Commission, the EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) has adopted guidance on methodological principles and scientific methods to be taken into account when assessing the safety of reference points for action (‘EFSA guidance’) (2). EFSA guidance describes a process for assessing whether the analytical concentration of a pharmacologically active substance, which can be determined by official control laboratories using a validated analytical method, is low enough to adequately protect human health.

(3)

EFSA guidance further specifies situations, in which a substance-specific risk assessment should be undertaken by EFSA in accordance with Regulation (EC) No 470/2009. In particular, in order to ensure an adequate level of health protection, substance-specific risk assessments should be performed for pharmacologically active substances, which cause blood dyscrasias (aplastic anaemia) or allergy (excluding skin sensitisation) or which are high potency carcinogens or inorganic substances.

(4)

Methodological principles and scientific methods for assessing the safety of reference points for action should therefore be adopted.

(5)

Commission Decision 2002/657/EC (3) lays down the minimum required performance limits of analytical methods used for detecting a limited number of substances, for which the use is not allowed, or is specifically prohibited in the Union. Those minimum required performance limits correspond to the average limit above which the detection of a substance or its residues can be considered as methodologically meaningful. The minimum required performance limits apply to the matrixes specified in Annex II to that Decision.

(6)

Pursuant to Commission Decision 2005/34/EC (4), the minimum required performance limits laid down in Decision 2002/657/EC are to be used as reference points for action irrespective of the food matrix tested for food of animal origin, imported from third countries. Food of animal origin, containing residues of a pharmacologically active substance in a concentration at or above the reference point for action, is to be considered not to comply with Union legislation, while food of animal origin containing concentrations below the reference points for action are not to be prohibited from entering the food chain. However, the setting of reference points for action should in no way serve as a pretext for condoning the illegal use of prohibited or non-allowed substances. Therefore any residues of those substances in food of animal origin should be considered undesirable. The reference points for action laid down in Decision 2005/34/EC have been based solely on analytical considerations, taking into account the lowest residue concentration, which can be detected and confirmed with a validated analytical method, without consideration of the toxic potential of the substances in question.

(7)

For chloramphenicol, malachite green and nitrofuran metabolites reference points for action have been laid down in Decision 2005/34/EC. For these substances, however, EFSA concluded that following EFSA guidance instead of the standard risk assessment methodology a substance-specific risk assessment was needed. Therefore, following the request of the Commission, the EFSA CONTAM Panel adopted scientific opinions on chloramphenicol in food and feed (5), on nitrofurans and their metabolites in food (6) and on malachite green in food (7).

(8)

It is therefore appropriate to lay down reference points for action for these substances, which take into account both the analytical considerations and the toxic potential of these substances. In view of the uncertainties, which EFSA identified in its risk assessments for chloramphenicol and the nitrofuran metabolites, the sensitivity of analytical methods should be improved, in order to enable enforcement of the lowest possible concentrations.

(9)

Detection of residues of prohibited or non-allowed substances, even below established reference points for action, could be a signal of misuse of such substances. In such cases Regulation (EC) No 470/2009 requires Member States and, as appropriate, the Commission, to take follow-up measures. To this end, information should be available to the Member States and the Commission through the Rapid Alert System for Food and Feed (8).

(10)

In order to allow official laboratories to adapt their methods to the updated reference points for action for chloramphenicol, malachite green and nitrofuran metabolites, a period of three years should be allowed to elapse before these lowered reference points for action become applicable.

(11)

As this Regulation takes over the provisions of Decision 2005/34/EC, updates and further expands them, for reasons of legal certainty Decision 2005/34/EC should be repealed.

(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)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‛the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

(3)

Japan is listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of eggs and egg products are authorised from the whole of its territory.

(4)

Japan had also requested to be authorised for imports into and transit through the Union of meat of poultry and has submitted the relevant information. The Commission has carried out an audit in Japan to evaluate the animal health controls in place for meat of poultry intended for export to the Union with favourable outcome. However, due to an outbreak of HPAI of subtype H5N6 in January 2018, the country could not satisfy the conditions laid down in Article 9 of Regulation (EC) No 798/2008 for being considered free from that disease and was therefore not authorised for that commodity.

(5)

More than 12 months have now past since HPAI was present in the territory of Japan and the country can now be considered free from that disease in accordance with Article 9 of Regulation (EC) No 798/2008. On the basis of the current epidemiological situation, it is therefore appropriate to amend the entry for Japan in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 to authorise that third country for imports into and transit through the Union of meat of poultry.

(6)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(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 (EU) 2017/625 subjects certain categories of animals and goods to systematic controls at border control posts prior to their entry into the Union.

(2)

It follows from Article 65(4) of Regulation (EU) 2017/625 that in case of suspected fraudulent or deceptive practices by an operator or in the case of serious or repeated infringements of the rules referred to in Article 1(2) of that Regulation, official controls on consignments with the same use or origin performed by the competent authorities at the border control posts should be intensified. Pursuant to Article 65(5) of Regulation (EU) 2017/625, the competent authorities’ decision to perform such intensified controls is to be notified to the Commission and the Member States through the information management system for official controls (IMSOC) referred to in Article 131 of that Regulation.

(3)

In order to ensure a harmonised approach to the coordinated performance of intensified official controls on certain goods entering the Union, detailed procedures for the coordinated performance of those controls should be established, including rules on the role of the IMSOC in this respect. For practical reasons, the coordinated performance of intensified controls at borders should be limited to the categories of consignments for which there is an identifiable listed establishment of origin, i.e. consignments of products of animal origin, germinal products, animal by-products and composite products.

(4)

When receiving notifications from the competent authorities in accordance with Article 65(5) of Regulation (EU) 2017/625, the Commission should in particular assess whether the non-compliance is based on suspected fraudulent or deceptive practices or on a potentially serious or repeated infringement of the rules referred to in Article 1(2) of Regulation (EU) 2017/625, for instance the placing on the market of products of animal origin containing levels of contaminants or residues of veterinary medicinal products which exceed the maximum residue limit, or of products which do not comply with Commission Regulation (EC) No 2073/2005 (2).

(5)

In order to reduce the risk of fraudulent or deceptive practices by way of presenting small consignments for official controls, the total weight of compliant consignments required to end the coordinated performance of intensified official controls should amount to at least ten times the weight of the consignment that initially triggered the measure. However, in order to avoid an unacceptable administrative and financial burden for the competent authorities and for operators, a maximum total weight of compliant consignments required to end the coordinated performance of intensified official controls should be set.

(6)

If, during the coordinated performance of intensified official controls, three consignments entering the Union reveal the same type of infringement indicated in the notification in accordance with Article 65(5) of Regulation (EU) 2017/625, the coordinated performance of intensified official controls should be maintained until its results and the action of the competent authorities of the third countries concerned are satisfactory. In that case, the Commission should request the competent authorities of the third countries to carry out the necessary investigations and measures in order to remedy the situation in the establishment of origin and report back to the Commission.

(7)

For reasons of the efficiency of the control system, it should be possible for the Member States to exclude certain consignments from the coordinated performance of intensified official controls, in cases where the consignments are to be refused entry into the Union on grounds other than the infringement for which the coordinated intensified official controls are performed.

(8)

Since Regulation (EU) 2017/625 applies from 14 December 2019, this Regulation should also apply from that date.

(9)

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

(1)

Under Article 47(1) of Directive 2006/43/EC, Member States may allow the transfer of audit working papers or other documents held by statutory auditors or audit firms approved by them, and of inspection or investigation reports relating to the audits in question, to the competent authorities of a third country only if those authorities meet requirements that have been declared adequate by the Commission and there are working arrangements on the basis of reciprocity between them and the competent authorities of the Member States concerned. Member States have a growing interest in further developing cooperation with the competent authorities of the People’s Republic of China in the area of statutory audit. In light of that interest, it needs to be determined whether the competent authorities of the People’s Republic of China meet requirements that are adequate for those purposes.

(2)

A decision on adequacy under Article 47(3) of Directive 2006/43/EC does not address other specific requirements for the transfer of audit working papers and other documents held by statutory auditors or audit firms and of inspection or investigation reports, such as the agreement on working arrangements on the basis of reciprocity between the competent authorities set out in Article 47(1)(d) of Directive 2006/43/EC, or the requirements for the transfer of personal data set out in Article 47(1)(e) of that Directive.

(3)

Cooperation over the transfer of audit working papers or other documents held by statutory auditors or audit firms and of inspection or investigation reports to the competent authority of a third country reflects the substantial public interest in carrying out independent public oversight. Accordingly, the competent authorities of Member States should, in the framework of the working arrangements referred to in Article 47(2) of Directive 2006/43/EC, ensure that the competent authorities of the People’s Republic of China use any documents transferred to them in accordance with Article 47(1) of that Directive only to exercise their functions of public oversight, external quality assurance and investigations of auditors and audit firms.

(4)

When inspections or investigations are carried out, statutory auditors and audit firms are not allowed to grant access to or to transmit their audit working papers or other documents to the competent authorities of the People’s Republic of China under any other conditions than those set out in Article 47 of Directive 2006/43/EC and in this Decision.

(5)

Without prejudice to Article 47(4) of Directive 2006/43/EC, Member States should ensure that, for the purposes of public oversight, quality assurance and investigations of statutory auditors and audit firms, contacts between the statutory auditors or audit firms approved by them and the competent authorities of the People’s Republic of China take place via the competent authorities of the Member States concerned.

(6)

In accordance with Article 47(1)(d) of Directive 2006/43/EC, the possibility for Member States to allow the transfer to the competent authorities of the People’s Republic of China of audit working papers or other documents held by statutory auditors or audit firms approved by them and of inspection or investigation reports is subject to the condition that working arrangements are agreed between the competent authorities concerned.

(7)

Member States should ensure that such working arrangements between their competent authorities and the competent authorities of the People’s Republic of China are agreed on the basis of reciprocity and subject to the conditions of Article 47(1) and (2) of Directive 2006/43/EC, including the protection of any professional secrets and commercial interests, including industrial and intellectual property, contained in such papers relating to the entities audited or to the statutory auditors and audit firms that audited those entities.

(8)

Where a transfer of audit working papers or other documents held by statutory auditors or audit firms and of inspection or investigation reports to the competent authorities of the People’s Republic of China involves the transfer of personal data, such a transfer is lawful only if it also complies with the requirements for international data transfers laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council (2). Article 47(1)(e) of Directive 2006/43/EC therefore requires Member States to ensure that the transfer of personal data between their competent authorities and the competent authorities of the People’s Republic of China complies with any applicable data protection principles and rules and, in particular, with the provisions of Chapter V of Regulation (EU) 2016/679. Member States should ensure that appropriate safeguards for the transfer of personal data are provided for, in accordance with Article 46 of Regulation (EU) 2016/679. In addition, Member States should ensure that the competent authorities of the People’s Republic of China will not further disclose personal data contained in the documents transferred without the prior agreement of the competent authorities of the Member States concerned.

(9)

The Ministry of Finance and the Securities Regulatory Commission (CSRC) of the People’s Republic of China are the two public oversight bodies that have competence in investigating auditors and audit firms, under the Accounting Law, the Law of Certified Public accountants and the Securities law of the People’s Republic of China. The Ministry of Finance is responsible for issuing practice licences to accounting firms, enforcing accounting rules, setting auditing standards, carrying out inspections and investigations of accounting firms and certified public accountants, and entering into regulatory cooperative agreements relating to oversight of the profession of certified public accountants. The CSRC, under the auspices of the State Council, is responsible for performing supervision of the securities market and for enforcing the Securities Law. It has powers to inspect companies listed on either the Shanghai Stock Exchange or the Shenzhen Stock Exchange and the accounting firms that perform audits of those listed companies. It is the authority responsible for the supervision and administration of securities issued in either one of those stock exchanges. Among its supervisory duties, the CSRC is competent to administer international cooperation affairs of the securities and futures sector. The CSRC has the power to establish an oversight cooperation mechanism with corresponding authorities of other jurisdictions for the purpose of cross-border oversight of the securities markets including, cooperation on audit matters.

(10)

Both the Ministry of Finance and the CSRC will be involved in the signing of future bilateral agreements for the transfer of audit working papers. The Ministry of Finance takes the lead in concluding agreements with the Member States and determines the CSCR’s participation in the negotiations and in the signing of the agreements depending on the scope and content of the agreements. Existing and former staff of the Ministry of Finance and the CSRC have the obligation to keep confidential the State, trade and work secrets acquired during supervisory activities and not to use such information for any unrelated matters.

(11)

Under the laws and regulations of the People’s Republic of China, the Ministry of Finance and the CSRC may transfer to the competent authorities of the Member States documents equivalent to those referred to in Article 47(1) of Directive 2006/43/EC that relate to investigations it may perform on such auditors and audit firms.

(12)

On that basis, taking also into account the technical advice of the Committee of European Auditing Oversight Bodies referred to in Article 30(7)(c) of Regulation (EU) No 537/2014 of the European Parliament and of the Council (3), the Ministry of Finance and the CSRC meet requirements that should be declared adequate for the purposes of Article 47(1)(c) of Directive 2006/43/EC.

(13)

This Decision does not affect the cooperation arrangements referred to in Article 25(4) of Directive 2004/109/ECof the European Parliament and of the Council (4).

(14)

Any conclusion on the adequacy of the requirements met by the competent authorities of a third country pursuant to the first subparagraph of Article 47(3) of Directive 2006/43/EC does not pre-empt any decision that the Commission may adopt on the equivalence of the public oversight, quality assurance, investigation and penalty systems for auditors and audit entities of that third country pursuant to Article 46(2) of that Directive.

(15)

This Decision aims to facilitate effective cooperation between the competent authorities of the Member States and those of the People’s Republic of China. Its purpose is to allow those authorities to exercise their functions of public oversight, external quality assurance and investigations and, at the same time, to protect the rights of the parties concerned. Where a competent authority decides to enter into working arrangements on the basis of reciprocity with the competent authorities of the People’s Republic of China in order to enable the transfer of audit working papers and other documents held by statutory auditors or audit firms and of inspection or investigation reports, the Member State concerned is under the obligation to communicate to the Commission the reciprocal working arrangements concluded with those authorities to allow the Commission to assess whether cooperation is in accordance with Article 47 of Directive 2006/43/EC.

(16)

The ultimate objective of cooperation on audit oversight between Member States’ competent authorities and the competent authorities of the People’s Republic of China is to reach mutual reliance on each other’s oversight systems and to enhance convergence in audit quality. Such a mutual reliance and enhanced convergence would be based on the equivalence of the audit oversight systems of the Union and of the People’s Republic of China. As a consequence, transfers of audit working papers or other documents held by statutory auditors or audit firms and of inspection or investigation reports should ultimately become the exception.

(17)

This Decision reflects the growing interest of Member States in further developing cooperation with the competent authorities of the People’s Republic of China in the area of statutory audit as a means to facilitate access of Union entities to the capital market of the People’s Republic of China and to encourage capital market activities in the Member States of companies with a registered office in the People’s Republic of China.

(18)

Given the present lack of practical experience in supervisory cooperation with the competent authorities of the People’s Republic of China this Decision should be applicable for a limited period of time.

(19)

Notwithstanding the time limitation, the Commission will monitor on a regular basis the market developments, evolution of the supervisory and regulatory frameworks and the effectiveness of supervisory cooperation, taking into account experience gained during supervisory cooperation, also based on Member States’ input. In particular, the Commission may undertake a specific review of this Decision at any time before the end of its expiration period where relevant developments make it necessary to re-assess the declaration of adequacy granted by this Decision. Such re-assessment could lead to the repeal of this Decision.

(20)

The European Data Protection Supervisor delivered an opinion on 20 May 2019.

(21)

The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 48(1) of Directive 2006/43/EC,