14.2.2018   

EN

Official Journal of the European Union

L 41/1

(1)

Regulation (EU) No 1380/2013 aims to progressively eliminate discards in all Union fisheries through the introduction of a landing obligation for catches of species subject to catch limits.

(2)

In accordance with Article 15(1)(a) of Regulation (EU) No 1380/2013, the landing obligation applies in fisheries for salmon from 1 January 2015.

(3)

Article 15(6) of Regulation (EU) No 1380/2013 empowers the Commission, in the absence of multiannual plans established pursuant to Article 9 of that Regulation, to adopt a discard plan specifying details of the implementation of the landing obligation for an initial period of three years that may be renewed for another period of three years. Those discard plan are to be adopted on the basis of joint recommendations developed by Member States in consultation with the relevant Advisory Councils.

(4)

Commission Delegated Regulation (EU) No 1396/2014 (2) established a discard plan concerning fisheries for salmon, herring, sprat and cod in the Baltic Sea. That discard plan includes i.a. an exemption from the landing obligation for cod and salmon on account of high survival rates demonstrated for those species as provided for in Article 15(4)(b) of Regulation (EU) No 1380/2013. Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017.

(5)

Regulation (EU) 2016/1139 of the European Parliament and of the Council (3) establishes a multiannual plan concerning certain Baltic Sea fisheries for cod, herring and sprat. That multiannual plan does not cover salmon stocks and Baltic Sea fisheries for that stock.

(6)

In the absence of a multiannual plan applicable to salmon stocks and Baltic Sea fisheries for that stock, details for implementing the landing obligation after the expiry of Delegated Regulation (EU) No 1396/2014 are to be adopted in the framework of a new discard plan based on a joint recommendation submitted by the Member States.

(7)

Denmark, Germany, Estonia, Latvia, Lithuania, Poland, Finland and Sweden have a direct fisheries management interest in the Baltic Sea. On 31 May 2017 those Member States have submitted a joint recommendation (4) to the Commission, after consulting the Baltic Sea Advisory Council. Scientific contribution was obtained from relevant scientific bodies.

(8)

The joint recommendation suggests that the exemption from the landing obligation for salmon caught with trap-nets, creels/pots, fyke-nets and pound nets, provided for by Delegated Regulation (EU) No 1396/2014, should continue to apply after 31 December 2017.

(9)

The joint recommendation is based on scientific evidence of high survivability, provided by the Baltic Sea Fisheries Forum (BALTFISH) and has been reviewed by the Scientific, Technical and Economic Committee for Fisheries (STECF). STECF concluded that, based on the fact that such gears operate by trapping fish inside a static netting structure, as opposed to entangling or hooking for example, it may be reasonably assumed that mortality for these gears will be low.

(10)

The measures suggested by the joint recommendation comply with Article 15(6) of Regulation (EU) No 1380/2013 and therefore, in line with Article 18(3) of Regulation (EU) No 1380/2013, they should be included in this Regulation.

(11)

Since Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017, this Regulation should apply from 1 January 2018,

(1)

‘Baltic Sea’ means ICES divisions IIIb, IIIc and IIId, as specified in Annex III to Regulation (EC) No 218/2009 of the European Parliament and of the Council (5).

14.2.2018   

EN

Official Journal of the European Union

L 41/4

(1)

The Union must ensure an effective protection of the integrity and proper functioning of its financial system and the internal market from money laundering and terrorist financing. Hence Directive (EU) 2015/849 provides that the Commission should identify high-risk third countries which present strategic deficiencies in their regimes on anti-money-laundering and countering terrorist financing that pose significant threats to the financial system of the Union.

(2)

The Commission should review the list of high-risk third countries listed in Delegated Regulation (EU) 2016/1675 (2) at appropriate times in light of the progress made by those high-risk third countries in removing the strategic deficiencies in their regime on anti-money-laundering and countering terrorist financing (‘AML/CFT’). The Commission should take account in its assessments of new information from international organisations and standard-setters, such as those issued by the Financial Action Task Force (FATF). In light of this information, the Commission should also identify additional high-risk third countries presenting strategic deficiencies in their AML/CFT regime.

(3)

In line with the criteria set out in Directive (EU) 2015/849, the Commission took into account the recent available information, in particular recent FATF Public Statements and the FATF document ‘Improving Global AML/CFT Compliance: ongoing process’, and FATF reports of the International Cooperation Review Group in relation to the risks posed by individual third countries in line with Article 9(4) of Directive (EU) 2015/849.

(4)

The FATF identified Sri Lanka, Trinidad and Tobago, and Tunisia as having strategic AML/CFT deficiencies that pose a risk to the international financial system, for which they have developed an action plan with the FATF.

(5)

Considering the high level of integration of the international financial system, the close connection of market operators, the high volume of cross-border transactions to or from the Union, as well as the degree of market opening, the Commission hence considers that any AML/CFT threat posed to the international financial system also represents a threat for the Union financial system.

(6)

In accordance with the latest relevant information, the Commission's analysis has concluded that Sri Lanka, Trinidad and Tobago, and Tunisia should be considered third-country jurisdictions which have strategic deficiencies in their AML/CFT regime that pose significant threats to the financial system of the Union in accordance with the criteria set out in Article 9 of Directive (EU) 2015/849. However, these countries have provided a written high-level political commitment to address the identified deficiencies and have developed an action plan with FATF, which would allow the requirements laid down in Directive (EU) 2015/849 to be met. The Commission will reassess these countries' status in the light of the implementation of the above commitment.

(7)

Delegated Regulation (EU) 2016/1675 should therefore be amended accordingly,

14.2.2018   

EN

Official Journal of the European Union

L 41/6

(1)

The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 0000080-05-7), commonly known as bisphenol A (BPA) is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate plastic and epoxy resins used in varnishes and coatings. BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.

(2)

The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011 (2). The authorisation is subject to a specific migration limit (SML) of 0,6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food (3). The European Food Safety Authority (the Authority) has reviewed scientific information and updated its opinion on BPA in 2006 (4), 2008 (5), 2010 (6) and 2011 (7). A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.

(3)

After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated. The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence. In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8), the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs.

(4)

The Authority adopted an opinion on 11 December 2014 (9), having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013. In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8 960 μg/kg bw per day. It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 μg/kg bw per day. The HED was used as a reference point for establishing a health-based guidance value for BPA.

(5)

To establish this health-based guidance value, the Authority applied an uncertainty factor of 2,5 for inter-species differences and 10 for intra-species differences. It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems. As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 μg/kg bw per day. However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the United States of America (USA).

(6)

The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure. In its opinion adopted on 11 December 2014, the Authority also estimated non-dietary sources of exposure as well as those from the diet. Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics. The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure.

(7)

Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI. The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials. Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents. The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups. In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used.

(8)

Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20 % is considered appropriate when setting the SML. Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health.

(9)

While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion. With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 (10) that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA. Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time.

(10)

The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time.

(11)

The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated. In order to do so, BPA should not be used to manufacture polycarbonate drinking cups or bottles which are intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (11).

(12)

In addition to its use in plastic food contact materials, BPA is used extensively in epoxy resins for varnishes and coatings, particularly for application on the interior of food cans. While specific measures provided for in Article 5 of Regulation (EC) No 1935/2004 have been adopted as regards BPA in plastic materials and articles, such measures have not been adopted as regards BPA in varnishes and coatings at the Union level. Therefore, in accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national provisions on BPA in varnishes and coatings provided those measures comply with the rules laid down in the Treaties.

(13)

In light of the introduction by Member States of divergent national measures applicable to BPA in food contact materials and the resulting technical and practical burdens reported by industry, and having regard to the contribution to dietary exposure of BPA from canned food identified in the Authority's opinion of 2014 and the extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropriate to establish restrictions for BPA used in varnishes and coatings.

(14)

The same assumption concerning exposure to BPA from plastic materials and articles applies to varnishes and coatings. In order to ensure the effective functioning of the internal market and to ensure a high level of protection for human health, the SML established for BPA from plastic materials and articles should also apply to varnishes and coatings applied to materials and articles, where that varnish or coating has been produced using BPA. As BPA may be used in food packaging containing foods for infants and young children, BPA should not migrate from varnishes and coatings applied to materials or articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.

(15)

In conjunction with the establishment of restrictions for varnishes and coatings, it is also necessary to define rules for verification of compliance with the restrictions. In particular, rules for migration testing and rules for expression of migration testing results should be established. Therefore it is appropriate to establish such rules for checking compliance with the restrictions for varnishes and coatings applied to materials and articles where those varnishes or coatings have been produced using BPA.

(16)

Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results. As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions.

(17)

Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them. On production of the varnished or coated material or article, the responsible business operator should document compliance with the applicable rules in a declaration of compliance which is made available to their customers. In order to ensure that the declaration provides sufficient information to enable verification of compliance, it is appropriate to specify the information that must be included in the declaration. In addition, competent authorities should be able to verify compliance with the applicable rules. Business operators should therefore be required to make available for the competent authorities appropriate supporting documentation, substantiating the declaration of compliance.

(18)

In order to ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this Regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this Regulation to remain on the market until the exhaustion of stocks.

(19)

Regulation (EU) No 10/2011 should therefore be amended accordingly.

(20)

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

(1)

‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;

(2)

‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;

(3)

‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance.

14.2.2018   

EN

Official Journal of the European Union

L 41/13

(1)

The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Pla i Llevant’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

(2)

The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2).

(3)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(4)

The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

14.2.2018   

EN

Official Journal of the European Union

L 41/14

(1)

In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Mergelland’ sent by the Netherlands and has published it in the Official Journal of the European Union  (2).

(2)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3)

In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Mergelland’ should be protected and entered in the register referred to in Article 104 of that Regulation.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,