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Document L:2018:308:FULL

Official Journal of the European Union, L 308, 4 December 2018


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 308

European flag  

English edition

Legislation

Volume 61
4 December 2018


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances ( 1 )

1

 

*

Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases ( 1 )

21

 

*

Commission Implementing Regulation (EU) 2018/1883 of 3 December 2018 amending Regulation (EU) No 468/2010 establishing the EU list of vessels engaged in illegal, unreported and unregulated fishing

30

 

 

DECISIONS

 

*

Council Decision (CFSP) 2018/1884 of 3 December 2018 extending and amending Decision 2010/452/CFSP on the European Union Monitoring Mission in Georgia, EUMM Georgia

41

 

*

Commission Implementing Decision (EU, Euratom) 2018/1885 of 30 November 2018 amending Decision 96/566/Euratom, EC authorising Finland not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (notified under document C(2018) 7840)

43

 

*

Commission Implementing Decision (EU, Euratom) 2018/1886 of 30 November 2018 amending Decision 90/184/Euratom, EEC authorising Denmark not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (notification under document C(2018) 7854)

45

 

*

Commission Implementing Decision (EU, Euratom) 2018/1887 of 30 November 2018 amending Decision 90/176/Euratom, EEC authorising France not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (notified under document C(2018) 7866)

47

 

*

Commission Implementing Decision (EU) 2018/1888 of 3 December 2018 determining that a temporary suspension of the preferential customs duty pursuant to Article 15 of Regulation (EU) No 19/2013 of the European Parliament and of the Council and pursuant to Article 15 of Regulation (EU) No 20/2013 of the European Parliament and of the Council is not appropriate for imports of bananas originating in Guatemala and Peru

49

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

REGULATIONS

4.12.2018   

EN

Official Journal of the European Union

L 308/1


COMMISSION REGULATION (EU) 2018/1881

of 3 December 2018

amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 131 thereof,

Whereas:

(1)

Regulation (EC) No 1907/2006 lays down specific registration duties and obligations on manufacturers, importers and downstream users to generate data on substances they manufacture, import or use to assess the risks related to these substances and to develop and recommend appropriate risk management measures.

(2)

The Commission Communication on the Second Regulatory Review on Nanomaterials (2) concluded that Regulation (EC) No 1907/2006 sets the best possible framework for the risk management of nanomaterials when they occur as forms of substances or mixtures but more specific requirements within the framework are necessary.

(3)

The Commission performed an impact assessment (3) and further concluded that it is necessary to clarify the registration duties and obligations for nanomaterials. The term nanoform should be defined for the purposes of Regulation (EC) No 1907/2006 on the basis of Commission Recommendation of 18 October 2011 on the definition of nanomaterial.

(4)

Nanoforms may have specific toxicological profiles and exposure patterns and may therefore require specific risk assessment and adequate sets of risk management measures.

(5)

Without the minimum standard information in the technical dossier and the chemical safety report specifically addressing nanoforms, it is not possible to ascertain whether the potential risks have been adequately assessed. Clarifications to requirements for the registration of substances with nanoforms and related downstream user obligations should be included in the Annexes I, III and VI to XII to Regulation (EC) No 1907/2006. This should ensure a clear and effective implementation with proportionate costs, guaranteeing a high level of protection of human health and the environment without adversely affecting innovation and competitiveness. The adopted changes for nanoforms should be without prejudice to the performance and documentation of risk assessment of other forms of the registered substance, unless it has implicitly included nanoforms in the assessment.

(6)

Manufacturers and importers should assess and where relevant, generate the necessary information and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report. A use may modify the nanoforms of the substance, potentially changing one nanoform into another form or generating a new nanoform. Downstream users should provide this information up the supply chain to ensure that the use is adequately covered by the registration dossier of the manufacturer or importer, or alternatively cover the specific use in their own chemical safety report.

(7)

As the majority of nanomaterials are expected to be nanoforms of phase-in substances, the conditions for the requirements for generation of new toxicological and ecotoxicological information on phase-in low volume substances should be elaborated to ensure that the assessment criteria are based also on the predicted properties of nanoforms. The existing qualitative or quantitative structure-activity relationship (QSAR) and other tools do not yet enable prioritisation; therefore, the insolubility information should be applied as a surrogate for potential toxicological and ecotoxicological aspects for the nanoforms of a substance.

(8)

For nanoforms, specific minimum characterisation information should be provided as part of the composition information under the substance identification. Particle size, shape and surface properties of a nanoform may influence its toxicological or ecotoxicological profile, exposure as well as behaviour in the environment.

(9)

For reasons of workability and proportionality, it should be possible to group nanoforms with similar characteristics in sets of similar nanoforms. The characterisers of the different nanoforms within sets of similar nanoforms should be provided in ranges of values that clearly define the boundaries of the set of similar nanoforms. When set of similar nanoform is defined, a justification should be provided that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the individual nanoforms within the set of similar nanoforms.

(10)

All different nanoforms covered by the registration should be considered by the registrant in the demonstration of safety. Similarly, the information on manufacture, uses of and exposure to the different nanoforms should be provided separately to demonstrate their safe use. Where defined, a set of similar nanoforms may be used to document this information jointly for the nanoforms within the set.

(11)

Nanoforms or sets of nanoforms, where defined, should be identified in the joint submission using the same nanoform characterisation principles and should provide the link between the nanoforms identified in the individual registrations and the relevant information in the joint submission.

(12)

To allow for adequate assessment of the relevance of any physicochemical, toxicological and ecotoxicological information for the different nanoforms, the test material should be appropriately characterised. For the same reasons, test conditions documented and a scientific justification for the relevance and adequacy of the utilised test material as well as documentation for the relevance and adequacy of the information obtained from means other than testing for the different nanoforms should be provided.

(13)

The rate of dissolution in water as well as in relevant biological and environmental media should always be considered for nanoforms as it represents important complementary information to water solubility as a basic physico-chemical property of nanoforms that may determine the approach to their risk assessment and testing.

(14)

The partition coefficient in octanol-water is generally used as a proxy for adsorption or accumulation but may often not be applicable to nanoforms. In those cases, the study of dispersion stability in the different relevant test media that significantly influences these endpoints as well as any estimations of exposure to nanoforms, should be considered instead.

(15)

Certain physico-chemical properties such as water solubility or partition coefficient in octanol-water serve as input to well established QSARs and other predictive models that can be used for adaptations of some of the information requirements. As the underlying assumptions may not always apply to nanomaterials, such adaptations should be used for nanoforms only with scientific justification. In specific cases, the dissolution rate in the relevant test media may be used instead.

(16)

To allow efficient assessment of the potential exposure for inhalable nanoforms, in particular in workplaces, information on dustiness should be provided for the different nanoforms.

(17)

The specific properties of the nanoform may sometimes prevent their uptake through the cell wall of bacteria, rendering the in vitro gene mutation study in bacteria (the AMES test B.13-14, OECD TG 471) inappropriate. To ensure that the tiered strategy for mutagenicity can still be implemented also in such cases, one or more other in vitro mutagenicity study(ies) in mammalian cells or other internationally recognised in vitro methods should be provided in such cases also for low-volume substances.

(18)

Although acute toxicity testing for the lowest tonnage is required via the oral route, for nanoforms, inhalation is considered as more appropriate route of exposure and should be required instead, unless the exposure to humans is unlikely.

(19)

For the generation of information on short term repeated dose and sub-chronic toxicity via inhalation route, testing of a nanoform should always include histopathological determination of brain, lung tissues as well as examination of bronchoalveolar lavage (BAL) fluid, kinetics and an appropriate recovery period, in line with the OECD technical guidance.

(20)

Unless the nanoform dissolves fast once entering the organism, the distribution of a nanoform in the body may affect the toxicological profile when compared to other forms of the same substance. Therefore, an assessment of the toxicokinetic behaviour should be available for the chemicals safety assessment of a nanoform, when such assessment is required. This should allow the development of effective testing strategy or its adaptation for the substance with nanoforms with the aim of minimising animal testing. Where relevant, a study complementing the compilation of existing toxicokinetic information should be proposed by the registrant or may be requested by the European Chemicals Agency (the Agency) in accordance with Article 40 or 41 of the Regulation (EC) No 1907/2006.

(21)

A number of specific physico-chemical properties in addition to those used to identify the different nanoforms may be considered relevant for scientific understanding of the hazard and exposure of a nanomaterial, with the necessary parameters depending on the individual case. For reasons of workability and proportionality, only registrants for substances (including any nanoforms) that are placed on the market in higher volumes than 10 tonnes/year should be required to explicitly consider such further information in case other particle properties significantly influence hazard or exposure to those nanoforms.

(22)

The adaptation of the standard testing requirements in Annexes VII to X to Regulation (EC) No 1907/2006 applying general rules for adaptation under Section 1 of Annex XI should address different nanoforms separately. For grouping of different nanoforms, the molecular structural similarity alone cannot serve as justification for the application of read-across or grouping.

(23)

The Agency, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006.

(24)

Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(25)

Compliance with the provisions of this Regulation should not be required immediately in order to allow all registrants and downstream users adequate time to adapt to the more specific requirements for substances with nanoforms. However, it should be possible for registrants to comply with those provisions already before the date of application.

(26)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 are amended in accordance with the Annex to this Regulation.

Article 2

By way of derogation from the second paragraph of Article 3, manufacturers and importers registering substances with nanoforms either as non-phase-in or phase-in substances pursuant to Article 5 of Regulation (EC) No 1907/2006 as well as downstream users generating chemical safety reports may comply with this Regulation before 1 January 2020.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2020.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 December 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 396, 30.12.2006, p. 1.

(2)  COM(2012) 572 final.

(3)  Impact assessment on Possible amendments of Annexes to REACH for registration of nanomaterials [SWD(2018)474].


ANNEX

1.   

Annex I to Regulation (EC) No 1907/2006 is amended as follows:

(a)

Subsection 0.1. is replaced by the following:

‘0.1.

The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms. The requirements speof the following hazard classes or categories setcific to nanoforms of a substance in this Annex apply to all nanoforms covered by the registration and without prejudice to requirements applicable to other forms of that substance. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration.’;

(b)

Subsection 0.3. is replaced by the following:

‘0.3.

The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The assessment shall address all nanoforms that are covered by the registration. The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.’;

(c)

Subsection 0.4. is replaced by the following:

‘0.4.

Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or “category” of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or “category” of substances. The manufacturer or importer shall provide a justification for this. Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and risk management measures.’;

(d)

The last paragraph in subsection 0.5. is replaced by the following:

‘If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration.’;

(e)

Point 0.6.3 is replaced by the following:

‘0.6.3.

Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:

(a)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;

(b)

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;

(c)

hazard class 4.1;

(d)

hazard class 5.1.’;

(f)

After subsection 0.11. the following subsection 0.11.bis is added:

‘0.11.bis

When nanoforms are covered by the chemical safety assessment, an appropriate metric for the assessment and presentation of the results in steps 1-6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation, including mass metric information, is preferable. When possible, a method for reciprocal conversion shall be indicated.’;

(g)

The following sentence is added after the first paragraph of section 1.0.3:

‘The assessment shall address all nanoforms that are covered by the registration.’;

(h)

The second paragraph of point 1.3.1. is replaced by the following:

‘The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.’;

(i)

Point 1.3.2. is replaced by the following:

‘1.3.2.

If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrants shall indicate and justify the action or decision he has taken as a result.’;

(j)

The second paragraph of subsection 2.2. is replaced by the following:

‘If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.’;

(k)

The following sentence is added at the end of point 3.0.2.:

‘The assessment shall address all nanoforms that are covered by the registration.’;

(l)

Point 3.2.1. is replaced by the following:

‘3.2.1.

The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.

The presentation and justification is applied to all nanoforms covered by the registration.’;

(m)

Point 3.2.2. is replaced by the following:

‘3.2.2.

If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.’;

(n)

Point 4.0.2. is replaced by the following:

‘4.0.2.

The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report. The assessment shall address all nanoforms that are covered by the registration:

Step 1

:

Comparison with the Criteria.

Step 2

:

Emission Characterisation.

The assessment shall also be summarised in the Safety Data Sheet under heading 12.’;

(o)

Subsection 4.2. is replaced by the following:

‘4.2.

Step 2: Emission Characterisation

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address all nanoforms that are covered by the registration.’;

(p)

The first paragraph of subsection 5.0. is replaced by the following:

‘The objective of the exposure assessment shall be to make a quantitative and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The assessment shall address all nanoforms that are covered by the registration. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:’;

(q)

The following sentence is added at the end of point 5.2.2.:

‘When nanoforms are covered by the registration, the emission estimation for these shall, where relevant, take account of situations when the conditions outlined in Annex XI section 3.2 point (c) are fulfilled.’;

(r)

Point 5.2.3. is replaced by the following:

‘5.2.3.

A characterisation of possible degradation, transformation, or reaction processes, and an estimation of environmental distribution and fate shall be performed.

When nanoforms are covered by the registration, a characterisation of the dissolution rate, the particle aggregation, the agglomeration and of the particle surface chemistry changes shall be included.’

2.   

Annex III to Regulation (EC) No 1907/2006 is replaced by the following:

‘CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

Criteria for substances and, when applicable, for nanoforms thereof, registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):

(a)

substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;

(b)

substances:

(i)

with dispersive or diffuse use(s) particularly where such substances are used in consumer mixtures or incorporated into consumer articles; and

(ii)

for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008 or for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media.’

3.   

Annex VI to Regulation (EC) No 1907/2006 is amended as follows:

(a)

The subtitle and the introductory text under the current subtitle ‘Guidance note on fulfilling the requirements of annexes VI to XI’ are replaced by the following:

‘NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI

Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use, and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.

A substance is defined in accordance with Article 3(1) and identified in accordance with section 2 in this Annex. A substance is always manufactured or imported in at least one form. A substance can also occur in more than one form.

For all nanoforms covered by the registration certain specific information items shall be provided. Nanoforms shall be characterised as provided for in this Annex. The registrant shall justify why the information provided in the joint registration, covering the information requirements for the registered substances with nanoforms, is adequate for assessing the nanoforms. Information relevant to cover information requirements for such a substance can also be submitted separately by individual registrants, where justified in accordance with Article 11(3).

More than one dataset may be required for one or more information requirements whenever there are significant differences in the properties relevant for the hazard, exposure and risk assessment and management of nanoforms. The information shall be reported in such a manner that it is clear which information in the joint submission pertains to which nanoform of the substance.

Where technically and scientifically justified, the methodologies set out in Annex XI.1.5 shall be used within a registration dossier when two or more forms of a substance are “grouped” for the purposes of one, more or possibly all the information requirements.

The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance.

Definition of a nanoform and a set of similar nanoforms:

 

On the basis of the Commission Recommendation of 18 October 2011 on the definition of nanomaterial (1), a nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.

 

For this purpose, “particle” means a minute piece of matter with defined physical boundaries; “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and “aggregate” means a particle comprising of strongly bound or fused particles.

 

A nanoform shall be characterised in accordance with section 2.4 below. A substance may have one or more different nanoforms, based on differences in the parameters in points 2.4.2 to 2.4.5.

 

A “set of similar nanoforms” is a group of nanoforms characterised in accordance with section 2.4 where the clearly defined boundaries in the parameters in the points 2.4.2 to 2.4.5 of the individual nanoforms within the set still allow to conclude that the hazard assessment, exposure assessment and risk assessment of these nanoforms can be performed jointly. A justification shall be provided to demonstrate that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the similar nanoforms in the set. A nanoform can only belong to one set of similar nanoforms

 

The term “nanoform”, when it is referred to in the other Annexes, shall refer to a nanoform or a set of similar nanoforms, when one has been defined, as defined in this Annex.’;

(b)

Step 1 is replaced by the following:

‘STEP 1 — GATHER AND SHARE EXISTING INFORMATION

The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance.

Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance including on all nanoforms of the substance that are covered by the registration, regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.

In addition, information on exposure, use and risk management measures in accordance with article 10 and this Annex should be collected. Considering all this information together, the registrant will be able to determine the need to generate further information.’;

(c)

Step 3 is replaced by the following:

‘STEP 3 — IDENTIFY INFORMATION GAPS

The registrant shall then compare the information needs for the substance with the information already available and the extent to which currently available information can be applied to all nanoforms covered by the registration and identify where there are gaps.

It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.’;

(d)

Step 4 is replaced by the following:

‘STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY

In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted.

The above approach shall also apply if there is a gap of available information for one or more nanoforms of the substance included in the jointly submitted registration dossier.

In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.

NOTES

Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions.

Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justification.’;

(e)

The introductory text in Section 2 Identification of the substance is replaced by the following:

‘For each substance, the information given in this section shall be sufficient to enable each substance to be identified and the different nanoforms to be characterised. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.’;

(f)

Subsection 2.3. is replaced by the following:

2.3.   Composition of each substance. Where a registration covers one or more nanoforms, these nanoforms shall be characterised pursuant to section 2.4 of this Annex.

2.3.1.   Degree of purity (%)

2.3.2.   Nature of impurities, including isomers and by-products

2.3.3.   Percentage of (significant) main impurities

2.3.4.   Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)

2.3.5.   Spectral data (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)

2.3.6.   High-pressure liquid chromatogram, gas chromatogram

2.3.7.   Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced.

2.4.   Characterisation of nanoforms of a substance: For each of the characterisation parameters, the information provided may be applicable to either an individual nanoform or a set of similar nanoforms provided that the boundaries of the set are clearly specified.

The information in points 2.4.2 – 2.4.5 shall be clearly assigned to the different nanoforms or sets of similar nanoforms identified in point 2.4.1.

2.4.1.   Names or other identifiers of the nanoforms or sets of similar nanoforms of the substance

2.4.2.   Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm.

2.4.3.   Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number.

2.4.4.   Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate

2.4.5.   Surface area (specific surface area by volume, specific surface area by mass or both)

2.4.6.   Description of the analytical methods or the appropriate bibliographical references for the information elements in this sub-section. This information shall be sufficient to allow the methods to be reproduced.’;

(g)

In section 3, the following introductory text is added after the title ‘INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)’:

‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information on manufacture and use under 3.1-3.7 shall include separate information on the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4.’;

(h)

In section 5, the introductory text is replaced by the following:

‘This information shall be consistent with that in the Safety Data Sheet where such a Safety Data Sheet is required according to Article 31.

Where a substance being registered is also manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 where relevant.’;

(i)

In section 6, the following introductory text is added after the title ‘INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFACTURER OR IMPORTER’:

‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 separately.’

4.   

Annex VII to Regulation (EC) No 1907/2006 is amended as follows:

(a)

In the introductory text, the following text is added after the third paragraph:

‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’;

(b)

Subsection 7.7 is replaced by the following:

‘7.7.

Water solubility

For nanoforms, in addition the testing of dissolution rate in water as well as in relevant biological and environmental media shall be considered.

7.7.

The study does not need to be conducted if:

the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or

the substance is readily oxidisable in water.

If the substance appears “insoluble” in water, a limit test up to the detection limit of the analytical method shall be performed.

For nanoforms the potential confounding effect of dispersion shall be assessed when conducting the study.’;

(c)

Subsection 7.8 is replaced by the following:

‘7.8.

Partition coefficient n-octanol/water

7.8.

The study does not need to be conducted if the substance is inorganic. If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.

For nanoforms the potential confounding effect of dispersion in octanol and water shall be assessed when conducting the study.

For nanoforms, whether of inorganic or organic substances, for which the partition coefficient n-octanol/water is not applicable the study of dispersion stability shall be considered instead.’;

(d)

After subsection 7.14., the following is added:

‘7.14bis

Dustiness

For nanoforms

7.14bis.

The study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.’;

(e)

Point 8.4.1. is replaced by the following:

‘8.4.1.

In vitro gene mutation study in bacteria

8.4.1.

The study does not need to be conducted for nanoforms where it is not appropriate. In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.’;

(f)

Point 8.5.1 is replaced by the following:

‘8.5.1.

By oral route

8.5.1.

The study need not be conducted if

a study on acute toxicity by the inhalation route (8.5.2) is available.

For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.’;

(g)

Point 9.1.1. is replaced by the following:

‘9.1.1.

Short-term toxicity testing on invertebrates (preferred species Daphnia)

The registrant may consider long-term toxicity testing instead of short-term.

9.1.1.

The study does not need to be conducted if:

there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes,

a long-term aquatic toxicity study on invertebrates is available, or

adequate information for environmental classification and labelling is available.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.’;

 

 

(h)

Point 9.1.2. is replaced by the following:

‘9.1.2.

Growth inhibition study aquatic plants (algae preferred)

9.1.2.

The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.’;

5.   

Annex VIII to Regulation (EC) No 1907/2006 is amended as follows:

(a)

In the introductory text, the following text is added after the first paragraph:

‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’;

(b)

A new section is inserted:

‘7.   INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

7.14ter.

Further information on physicochemical properties

Only for nanoforms

Further testing for nanoforms covered by the registration shall be considered by the registrant or may be required by the Agency in accordance with Article 41, if there is an indication that specific additional particle properties significantly influence the hazard of or the exposure to those nanoforms.’;

(c)

Subsection 8.5. is replaced by the following:

‘8.5.

Acute toxicity

8.5.

The study/ies do(es) not generally need to be conducted if:

the substance is classified as corrosive to the skin.

In addition to the oral route (8.5.1.) or to the inhalation route (8.5.2) for nanoforms, for substances other than gases, the information mentioned under 8.5.1. to 8.5.3. shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided.’;

(d)

Point 8.6.1 is replaced by the following:

‘8.6.1.

Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

8.6.1.

The short-term toxicity study (28 days) does not need to be conducted if:

a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administration were used, or

where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products, or

relevant human exposure can be excluded in accordance with Annex XI Section 3.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

inhalation of the substance is unlikely, and

skin contact in production and/or use is likely, and

the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

For nanoforms toxicokinetics shall be considered including recovery period and, where relevant, lung clearance.

The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate;

and one of the following conditions is met:

other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or

appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short-term toxicity study but which are liable to result in adverse effects after prolonged exposure.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of:

failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or

toxicity of particular concern (e.g. serious/severe effects), or

indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, and in particular for nanoforms indirect genotoxicity), or

the route of exposure used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made, or

particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected), or

effects shown in substances with a clear relationship in molecular structure with the substance being studied, were not detected in the 28 or the 90 days study.’;

(e)

Subsection 8.8. is replaced by the following:

‘8.8.

Toxicokinetics

 

8.8.1.

Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information.

For nanoforms without high dissolution rate in biological media a toxicokinetics study shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case such an assessment cannot be performed on the basis of relevant available information, including from the study conducted in accordance with 8.6.1.

The choice of the study will depend on the remaining information gaps and the results of the chemical safety assessment.’;

(f)

Point 9.1.3 is replaced by the following:

‘9.1.3.

Short-term toxicity testing on fish: the registrant may consider long-term toxicity testing instead of short-term.

9.1.3.

The study does not need to be conducted if:

there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

a long-term aquatic toxicity study on fish is available.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.’;

(g)

Point 9.1.4. is replaced by the following:

‘9.1.4.

Activated sludge respiration inhibition testing

9.1.4.

The study does not need to be conducted if:

there is no emission to a sewage treatment plant, or

there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or

the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.’;

(h)

Subsection 9.2. is replaced by the following:

‘9.2.

Degradation

9.2.

Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance.

For nanoforms that are not soluble, nor have high dissolution rate, such test(s) shall consider morphological transformation (e.g. irreversible changes in particle size, shape and surface properties, loss of coating), chemical transformation (e.g. oxidation, reduction) and other abiotic degradation (e.g. photolysis).

The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.’;

(i)

Section 9.2.2 is replaced by the following:

‘9.2.2.

Abiotic

9.2.2.1.

Hydrolysis as a function of pH.

9.2.2.1.

The study does not need to be conducted if:

the substance is readily biodegradable, or

the substance is highly insoluble in water.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.’;

(j)

Point 9.3.1. is replaced by the following:

‘9.3.1.

Adsorption/desorption screening

9.3.1.

The study does not need to be conducted if:

based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient), or

the substance and its relevant degradation products decompose rapidly.

For nanoforms, use of any physicochemical property (e.g. octanol-water partition coefficient) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.’;

6.   

Annex IX to Regulation (EC) No 1907/2006 is amended as follows:

(a)

In the introductory text, the following text is added after the second paragraph:

‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’;

(b)

Point 8.6.2 is replaced by the following:

‘8.6.2.

Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure.

8.6.2.

The sub-chronic toxicity study (90 days) does not need to be conducted if:

a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure, or

a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or

a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake), or

the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day “limit test”, particularly if such a pattern is coupled with limited human exposure.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1)

skin contact in production and/or use is likely; and

(2)

the physicochemical properties suggest a significant rate of absorption through the skin; and

(3)

one of the following conditions is met:

toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, or

systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, or

in vitro tests indicate significant dermal absorption, or

significant dermal toxicity or dermal penetration is recognised for structurally-related substances.

Testing by the inhalation route is appropriate if:

exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

For nanoforms toxicokinetics shall be considered including recovery period and, where relevant, lung clearance.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:

failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a NOAEL is absence of adverse toxic effects, or

toxicity of particular concern (e.g. serious/severe effects), or

indications of an effect for which the available evidence is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, and in particular for nanoforms indirect genotoxicity), or

particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity to humans may be expected).’;

(c)

Point 9.2.1.2. is replaced by the following:

‘9.2.1.2.

Simulation testing on ultimate degradation in surface water

9.2.1.2.

The study need not be conducted if:

 

the substances is highly insoluble in water, or

 

the substance is readily biodegradable.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.’;

(d)

Subsection 9.3. is replaced by the following:

‘9.3.

Fate and behaviour in the environment

 

9.3.2.

Bioaccumulation in aquatic species, preferably fish

9.3.2.

The study need not be conducted if:

 

the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or

 

direct and indirect exposure of the aquatic compartment is unlikely.

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for bioaccumulation or unlikely direct and indirect exposure of the aquatic compartment.

9.3.3.

Further information on adsorption/desorption depending on the results of the study required in Annex VIII

9.3.3.

The study need not be conducted if:

 

based on the physicochemical properties, the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or

 

the substance and its degradation products decompose rapidly.

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.’;

(e)

Subsection 9.4 is replaced by the following:

‘9.4.

Effects on terrestrial organisms

9.4.

These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified.

The choice of the appropriate tests depends on the outcome of the chemical safety assessment.

In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term.’;

7.   

Annex X to Regulation (EC) No 1907/2006 is amended as follows:

(a)

In the introductory text, the following text is added after the second paragraph:

‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’;

(b)

Point 8.6.3. is replaced by the following:

 

‘8.6.3.

A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:

serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or

effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or

the substance may have a dangerous property that cannot be detected in a 90-day study.

If nanoforms are covered by the registration, physicochemical characteristics, in particular particle size, shape and other morphological parameters, surface functionalisation and surface area, as well as molecular structure shall be taken into consideration when determining if one of the conditions above are met.’;

8.   

Annex XI to Regulation (EC) No 1907/2006 is amended as follows:

(a)

In the introductory text, the following text is added after the last paragraph:

‘The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.’;

(b)

Point 1.1.3. is replaced by the following:

‘1.1.3.   Historical human data

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.

The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:

(1)

the proper selection and characterisation of the exposed and control groups;

(2)

adequate characterisation of exposure;

(3)

sufficient length of follow-up for disease occurrence;

(4)

valid method for observing an effect;

(5)

proper consideration of bias and confounding factors; and

(6)

a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’;

(c)

Subsection 1.2. is replaced by the following:

‘1.2.   Weight of evidence

There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.

There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.

Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:

 

further testing on vertebrate animals for that property shall be omitted,

 

further testing not involving vertebrate animals may be omitted.

In all cases adequate and reliable documentation shall be provided.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’;

(d)

Subsection 1.3. is replaced by the following:

‘1.3.   Qualitative or Quantitative structure-activity relationship ((Q)SAR)

Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

results are derived from a (Q)SAR model whose scientific validity has been established,

the substance falls within the applicability domain of the (Q)SAR model,

results are adequate for the purpose of classification and labelling and/or risk assessment, and

adequate and reliable documentation of the applied method is provided.

The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’;

(e)

The last paragraph in Section 1.4 is replaced by the following:

‘Such confirmation may be waived if the following conditions are met:

(1)

results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

(2)

results are adequate for the purpose of classification and labelling and/or risk assessment; and

(3)

adequate and reliable documentation of the applied method is provided.

When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.’;

(f)

The first paragraph in Section 1.5 is replaced by the following:

‘Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint. The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately. For grouping different nanoforms of the same substance the molecular structural similarities alone cannot serve as a justification.

If nanoforms covered by a registration are grouped or placed in a “category” with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner.’

9.   

Annex XII to Regulation (EC) No 1907/2006 is amended as follows:

(a)

The introductory text is replaced by the following:

‘INTRODUCTION

The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a mixture or in an article.

The assessment shall address all nanoforms that are covered by the registration. Justifications and conclusions drawn from the assessment shall be relevant to the nanoforms, from their receipt by the downstream user, for his own uses and for his identified uses further down the supply chain.

In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation.

When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, an appropriate metric for the assessment and presentation of the results in steps 1- 6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation is preferable, ensuring availability of mass metric information.

Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account.

The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps:’;

(b)

Under Step 2, the following text is added after the first paragraph:

‘When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, the assessment shall cover the hazard, PBT and vPvB assessment of nanoforms(s) as used.’;

(c)

Under Step 2, the third paragraph is replaced by the following:

‘In those cases where the downstream user considers that information, in addition to that provided by the supplier, is necessary for producing his Chemical Safety Report, the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting for results of further testing, he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that he has put in place. The above record taking shall address all nanoforms that are covered by his own uses or his identified uses down the supply chain. Such information shall be relevant to the nanoforms.’


(1)  OJ L 275, 20.10.2011, p. 38.


4.12.2018   

EN

Official Journal of the European Union

L 308/21


COMMISSION IMPLEMENTING REGULATION (EU) 2018/1882

of 3 December 2018

on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Articles 8(2) and 9(2) thereof,

Whereas:

(1)

Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to animals or humans, including rules for the prioritisation and categorisation of listed diseases that are of concern at Union level. Article 5 of Regulation (EU) 2016/429 provides that disease-specific rules for the prevention and control of diseases apply to the listed diseases, as referred to in that Article and in Annex II to that Regulation. Annex II to Regulation (EU) 2016/429 was amended by Commission Delegated Regulation (EU) 2018/1629 (2), and those amendments apply from 21 April 2021.

(2)

Rules for the prevention and control of listed diseases should only apply to species and groups of species which can transmit such listed diseases, by virtue of either being susceptible to them or by acting as vectors.

(3)

Listed diseases require different types of management measures, as set out in the disease prevention and control rules provided for in Article 9 of Regulation (EU) 2016/429, and having regard to the potential seriousness of their impact on public or animal health, the economy, society or on the environment. Those measures range from basic responsibilities and obligations, such as reporting and the notification of the occurrence or suspicion of a listed disease and eradication programmes, to in–depth Union–wide disease-specific surveillance and eradication measures, as well as measures related to the movement of animals and products of animal origin in the Union and their entry into the Union.

(4)

Certain criteria are laid down in Articles 8(2) and (3) and 9(1) and (2) of Regulation (EU) 2016/429 and in Annex IV thereto, for the purpose of listing specific species or groups of species subject to the disease prevention and control rules laid down in that Regulation, as well as the methods of applying the disease prevention and control rules to the listed diseases.

(5)

The Commission, with the assistance of the European Food Safety Authority (EFSA) and with the benefit of scientific knowledge provided by the EU Animal Health Reference Laboratories, carried out a systematic assessment of listed diseases which require Union intervention. It also took into account available information from the World Organisation for Animal Health.

(6)

The systematic assessment by the Commission also took into account various factors, such as the species susceptible to certain listed diseases, disease reservoirs and disease vectors, and whether or not the listed disease is currently present in the Union, and how the listed disease is transmitted between animals, and from animals to humans, and its potential impact on animal and human health, including its morbidity and mortality rates. The systematic assessment also considered the wider impact of these listed diseases, such as their impact on the economy, society, animal welfare, the environment and biodiversity.

(7)

For the purposes of the systematic assessment, EFSA delivered scientific opinions on infection with Brucella abortus, B. melitensis and B. suis (3), infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis(4), infection with bluetongue virus (serotypes 1-24) (5), anthrax (6), surra (Trypanosoma evansi(7), Ebola virus disease (8), paratuberculosis (9), Japanese encephalitis (10), West Nile fever (11), infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) (12), infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (13), bovine viral diarrhoea (14), bovine genital campylobacteriosis (15), trichomonosis (16), enzootic bovine leukosis (17), contagious caprine pleuropneumonia (18), ovine epididymitis (Brucella ovis(19), Venezuelan equine encephalomyelitis (20), equine encephalomyelitis (Eastern and Western) (21), infection with Aujeszky's disease virus (22), infection with porcine reproductive and respiratory syndrome virus (23), avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis(24), infection with Salmonella Pullorum, S. Gallinarum and S. arizonae (25), infection with low pathogenic avian influenza viruses (26), infestation with Varroa spp. (Varroosis) (27), infection with Batrachochytrium salamandrivorans (28) and Koi herpes virus disease (29) in accordance with Article 8(3) of the Regulation (EU) 2016/429 and Annex IV thereto, and it followed the method set out in its Scientific Opinion, adopted on 5 April 2017, on an ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law (30).

(8)

As Regulation (EU) 2016/429 applies from 21 April 2021, the measures provided for in 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,

HAS ADOPTED THIS REGULATION:

Article 1

For the purposes of this Regulation, the following definitions apply:

(1)   ‘category A disease’: means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1)(a) of Regulation (EU) 2016/429;

(2)   ‘category B disease’: means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1)(b) of Regulation (EU) 2016/429;

(3)   ‘category C disease’: means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in Article 9(1)(c) of Regulation (EU) 2016/429;

(4)   ‘category D disease’: means a listed disease for which measures are needed to prevent it from spreading on account of its entry into the Union or movements between Member States, as referred to in Article 9(1)(d) of Regulation (EU) 2016/429;

(5)   ‘category E disease’: means a listed disease for which there is a need for surveillance within the Union, as referred to in Article 9(1)(e) of Regulation (EU) 2016/429.

Article 2

The disease prevention and control rules for listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 shall apply to the categories of listed diseases for the listed species and groups of listed species referred to in the table set out in the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 21 April 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 December 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 84, 31.3.2016, p. 1.

(2)  Commission Delegated Regulation (EU) 2018/1629 of 25 July 2018 amending the list of diseases set out in Annex II to Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 272, 31.10.2018, p. 11).

(3)  EFSA Journal 2017;15(7):4889.

(4)  EFSA Journal 2017;15(8):4959.

(5)  EFSA Journal 2017;15(8):4957.

(6)  EFSA Journal 2017;15(7):4958.

(7)  EFSA Journal 2017;15(7):4892.

(8)  EFSA Journal 2017;15(7):4890.

(9)  EFSA Journal 2017;15(7):4960.

(10)  EFSA Journal 2017;15(7):4948.

(11)  EFSA Journal 2017;15(8):4955.

(12)  EFSA Journal 2017;15(10):4995.

(13)  EFSA Journal 2017;15(7):4947.

(14)  EFSA Journal 2017;15(8):4952.

(15)  EFSA Journal 2017;15(10):4990.

(16)  EFSA Journal 2017;15(10):4992.

(17)  EFSA Journal 2017;15(8):4956.

(18)  EFSA Journal 2017;15(10):4996.

(19)  EFSA Journal 2017;15(10):4994.

(20)  EFSA Journal 2017;15(8):4950.

(21)  EFSA Journal 2017;15(7):4946.

(22)  EFSA Journal 2017;15(7):4888.

(23)  EFSA Journal 2017;15(7):4949.

(24)  EFSA Journal 2017;15(8):4953.

(25)  EFSA Journal 2017;15(8):4954.

(26)  EFSA Journal 2017;15(7):4891.

(27)  EFSA Journal 2017;15(10):4997.

(28)  EFSA Journal 2017;15(11):5071.

(29)  EFSA Journal 2017;15(7):4907.

(30)  EFSA Journal 2017;15(7):4783.


ANNEX

TABLE REFERRED TO IN ARTICLE 2

Name of listed disease

Category of listed disease

Listed species

Species and group of species

Vector species

Foot and mouth disease

A+D+E

Artiodactyla, Proboscidea

 

Infection with rinderpest virus

A+D+E

Artiodactyla

 

Infection with Rift Valley fever virus

A+D+E

Perissodactyla, Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae, Moschidae, Proboscidea

Culicidae

Infection with Brucella abortus, B. melitensis, B. suis

B+D+E

Bison ssp., Bos ssp., Bubalus ssp., Ovis ssp., Capra ssp.

 

D+E

Artiodactyla others than Bison ssp., Bos ssp., Bubalus ssp., Ovis ssp., Capra ssp.

E

Perissodactyla, Carnivora, Lagomorpha

Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae, M. tuberculosis)

B+D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

D+E

Artiodactyla others than Bison ssp., Bos ssp., Bubalus ssp.

E

Mammalia (terrestrial)

Infection with rabies virus

B+D+E

Carnivora, Bovidae, Suidae, Equidae, Cervidae, Camelidae

 

E

Chiroptera

Infestation with Echinococcus multilocularis

C+D+E

Canidae

 

Infection with bluetongue virus (serotypes 1-24)

C+D+E

Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae, Tragulidae

Culicoides spp.

Infection with epizootic haemorrhagic disease virus

D+E

Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Moschidae, Tragulidae

Culicoides spp.

Anthrax

D+E

Perissodactyla, Artiodactyla, Proboscidea

 

Surra (Trypanosoma evansi)

D+E

Equidae, Artiodactyla

Tabanidae

Ebola virus disease

D+E

Non-human primates (apes)

 

Paratuberculosis

E

Bison ssp., Bos ssp., Bubalus ssp., Ovis ssp., Capra ssp., Camelidae, Cervidae

 

Japanese encephalitis

E

Equidae

Culicidae

West Nile fever

E

Equidae, Aves

Culicidae

Q fever

E

Bison ssp., Bos ssp., Bubalus ssp., Ovis ssp., Capra ssp.

 

Infection with lumpy skin disease virus

A+D+E

Bison ssp., Bos ssp., Bubalus ssp.

Haematophagous arthropods

Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia)

A+D+E

Bison ssp., Bos ssp., Bubalus ssp., Syncerus cafer

 

Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis

C+D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

D+E

Camelidae, Cervidae

Bovine viral diarrhoea

C+D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

Bovine genital campylobacteriosis

D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

Trichomonosis

D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

Enzootic bovine leukosis

C+D+E

Bison ssp., Bos ssp., Bubalus ssp.

 

Sheep pox and goat pox

A+D+E

Ovis ssp., Capra ssp.

 

Infection with peste des petits ruminants virus

A+D+E

Ovis ssp., Capra ssp., Camelidae, Cervidae

 

Contagious caprine pleuropneumonia

A+D+E

Ovis ssp., Capra ssp., Gazella ssp.

 

Ovine epididymitis (Brucella ovis)

D+E

Ovis ssp., Capra ssp.

 

African horse sickness

A+D+E

Equidae

Culicoides spp.

Infection with Burkholderia mallei (Glanders)

A+D+E

Equidae, Capra ssp., Camelidae

 

Infection with equine arteritis virus

D+E

Equidae

 

Equine infectious anaemia

D+E

Equidae

Tabanidae

Dourine

D+E

Equidae

 

Venezuelan equine encephalomyelitis

D+E

Equidae

Culicidae

Contagious equine metritis

D+E

Equidae

 

Equine encephalomyelitis (Eastern and Western)

E

Equidae

Culicidae

Classical swine fever

A+D+E

Suidae, Tayassuidae

 

African swine fever

A+D+E

Suidae

Ornithodoros

Infection with Aujeszky's disease virus

C+D+E

Suidae

 

Infection with porcine reproductive and respiratory syndrome virus

D+E

Suidae

 

Highly pathogenic avian influenza

A+D+E

Aves

 

Infection with Newcastle disease virus

A+D+E

Aves

 

Avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis)

D+E

Gallus gallus, Meleagris gallopavo

 

Infection with Salmonella Pullorum, S. Gallinarum, S. arizonae

D+E

Gallus gallus, Meleagris gallopavo, Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.

 

Infection with low pathogenic avian influenza viruses

D+E

Aves

 

Avian chlamydiosis

D+E

Psittaciformes

 

Infestation with Varroa spp. (Varroosis)

C+D+E

Apis

 

Infestation with Aethina tumida (Small hive beetle)

D+E

Apis, Bombus ssp.

 

American foulbrood

D+E

Apis

 

Infestation with Tropilaelaps spp.

D+E

Apis

 

Infection with Batrachochytrium salamandrivorans

D+E

Caudata

 

Epizootic haematopoietic necrosis

A+D+E

Rainbow trout (Oncorhynchus mykiss), redfin perch (Perca fluviatilis)

Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (Carassius carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophthalmichthys molitrix), chub (Leuciscus spp.), roach (Rutilus rutilus), rudd (Scardinius erythrophthalmus), tench (Tinca tinca)

Viral haemorrhagic septicaemia

C+D+E

Herring (Clupea spp.), whitefish (Coregonus ssp.), pike (Esox lucius), haddock (Melanogrammus aeglefinus), Pacific cod (Gadus macrocephalus), Atlantic cod (Gadus morhua), Pacific salmon (Oncorhynchus spp.) rainbow trout (Oncorhynchus mykiss), rockling (Onos mustelus), brown trout (Salmo trutta), turbot (Scophthalmus maximus), sprat (Sprattus sprattus), grayling (Thymallus thymallus), olive flounder (Paralichthys olivaceus), marble trout (Salmo marmoratus), lake trout (Salvelinus namaycush), wrasse (Labridae spp., lumpfish (Cyclopteridae spp.)

Beluga (Huso huso), Danube sturgeon (Acipenser gueldenstaedtii), sterlet sturgeon (Acipenser ruthenus), starry sturgeon (Acipenser stellatus), sturgeon (Acipenser sturio), Siberian sturgeon (Acipenser baerii), bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (Carassius carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophthalmichthys molitrix), chub (Leuciscus spp.), roach (Rutilus rutilus), rudd (Scardinius erythrophthalmus), tench (Tinca tinca), North African catfish (Clarias gariepinus), pike (Esox lucius), catfish (Ictalurus spp.), black bullhead (Ameiurus melas), channel catfish (Ictalurus punctatus), pangas catfish (Pangasius pangasius), pike perch (Sander lucioperca), wels catfish (Silurus glanis), European seabass (Dicentrarchus labrax), striped bass (Morone chrysops x Morone saxatilis), flathead grey mullet (Mugil cephalus), red drum (Sciaenops ocellatus), meagre (Argyrosomus regius), shi drum (Umbrina cirrosa), true tuna (Thunnus spp.), Atlantic bluefin tuna (Thunnus thynnus), white grouper (Epinephelus aeneus), dusky grouper (Epinephelus marginatus), Senegalese solea (Solea senegalensis), common sole (Solea solea), common pandora (Pagellus erythrinus), common dentex (Dentex dentex), gilthead seabream (Sparus aurata), white seabream (Diplodus sargus), black spot seabream (Pagellus bogaraveo), red sea bream (Pagrus major), sharpsnout seabream (Diplodus puntazzo), common two-banded seabream (Diplodus vulgaris), red porgy (Pagrus pagrus), tilapia spp. (Oreochromis), brook trout (Salvelinus fontinalis), arctic charr (Salvelinus alpinus)

Infectious haematopoietic necrosis

C+D+E

Chum salmon (Oncorhynchus keta), coho salmon (Oncorhynchus kisutch), Masou salmon (Oncorhynchus masou), rainbow trout (Oncorhynchus mykiss), sockeye salmon (Oncorhynchus nerka), pink salmon (Oncorhynchus rhodurus), chinook salmon (Oncorhynchus tshawytscha), Atlantic salmon (Salmo salar), lake trout (Salvelinus namaycush), marble trout (Salmo marmoratus), brook trout (Salvelinus fontinalis), arctic charr (Salvelinus alpinus), whitespotted charr (Salvelinus leucomaenis)

Beluga (Huso huso), Danube sturgeon (Acipenser gueldenstaedtii), sterlet sturgeon(Acipenser ruthenus), starry sturgeon (Acipenser stellatus), sturgeon (Acipenser sturio), Siberian sturgeon (Acipenser Baerii), bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (Carassius carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophthalmichthys molitrix), chub (Leuciscus spp.), roach (Rutilus rutilus), rudd (Scardinius erythrophthalmus), tench (Tinca tinca), North African catfish (Clarias gariepinus), catfish (Ictalurus spp.), black bullhead (Ameiurus melas), channel catfish (Ictalurus punctatus), pangas catfish (Pangasius pangasius), pike perch (Sander lucioperca), wels catfish (Silurus glanis), Atlantic halibut (Hippoglossus hippoglossus), flounder (Platichthys flesus), Atlantic cod (Gadus morhua), haddock (Melanogrammus aeglefinus), noble crayfish (Astacus astacus), signal crayfish (Pacifastacus leniusculus), redswamp crayfish (Procambarus clarkii)

Infection with HPR-deleted infectious salmon anaemia virus

C+D+E

Rainbow trout (Oncorhynchus mykiss), Atlantic salmon (Salmo salar), brown and sea trout (Salmo trutta)

 

Koi herpes virus disease

E

Common carp and koi carp (Cyprinus carpio)

Goldfish (Carassius auratus), grass carp (Ctenopharyngodon idella)

Infection with Mikrocytos mackini

A+D+E

Pacific oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica), Olympia flat oyster (Ostrea conchaphila), European flat oyster (Ostrea edulis)

 

Infection with Perkinsus marinus

A+D+E

Pacific oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica)

European lobster (Homarus gammarus), marine crabs (Brachyura spp.), Yabi crayfish (Cherax destructor), giant river prawn (Macrobrachium rosenbergii), spiny lobsters (Palinurus spp.), swimming crab (Portunus puber), Indopacific swamp crab (Scylla serrata), Indian white prawn (Penaeus indicus), kuruma prawn (Penaeus japonicus), caramote prawn (Penaeus kerathurus), blue shrimp (Penaeus stylirostris), whiteleg shrimp (Penaeus vannamei)

Infection with Bonamia exitiosa

C+D+E

Australian mud oyster (Ostrea angasi), Chilean flat oyster (Ostrea chilensis), European flat oyster (Ostrea edulis)

Portuguese oyster (Crassostrea angulata), Pacific cupped oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica)

Infection with Bonamia ostreae

C+D+E

Australian mud oyster (Ostrea angasi), Chilean flat oyster (Ostrea chilensis), Olympia flat oyster (Ostrea conchaphila), Asian oyster (Ostrea denselammellosa), European flat oyster (Ostrea edulis), Argentinian oyster (Ostrea puelchana)

Common edible cockle (Cerastoderma edule), wedge shell (Donax trunculus), sand gaper (Mya arenaria), northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), European aurora venus clam (Venerupis aurea), pullet carpet shell (Venerupis pullastra), warty venus (Venus verrucosa), Great Atlantic scallop (Pecten maximus)

Infection with Marteilia refringens

C+D+E

Australian mud oyster (Ostrea angasi), Chilean flat oyster (Ostrea chilensis), European flat oyster (Ostrea edulis), Argentinian oyster (Ostrea puelchana)

Common edible cockle (Cerastoderma edule), wedge shell (Donax trunculus), sand gaper (Mya arenaria), northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), European aurora venus clam (Venerupis aurea), pullet carpet shell (Venerupis pullastra), warty venus (Venus verrucosa)

Infection with Taura syndrome virus

A+D+E

Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (Penaeus stylirostris), Pacific white shrimp (Penaeus vannamei)

Penshells (Atrina spp.), common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica), wedge shell (Donax trunculus), Ezo abalone (Haliotis discus hannai), tuberculate abalone (Haliotis tuberculata), periwinkles (Littorina littorea), northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), sand gaper (Mya arenaria), blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), common cuttlefish (Sepia officinalis), stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), pullet carpet shell (Venerupis pullastra), warty venus (Venus verrucosa), European lobster (Homarus gammarus), marine crabs (Brachyura spp.), Yabi crayfish (Cherax destructor), giant river prawn (Macrobrachium rosenbergii), spiny lobsters (Palinurus spp), swimming crab (Portunus puber), Indopacific swamp crab (Scylla serrata), Indian white prawn (Penaeus indicus), kuruma prawn (Penaeus japonicus), caramote prawn (Penaeus kerathurus)

Infection with yellow head virus

A+D+E

Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (Penaeus duorarum), kuruma prawn (Penaeus japonicus), black tiger shrimp (Penaeus monodon), Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (Penaeus stylirostris), Pacific white shrimp (Penaeus vannamei)

Penshells (Atrina spp.), common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica), wedge shell (Donax trunculus), Ezo abalone (Haliotis discus hannai), tuberculate abalone (Haliotis tuberculata), periwinkles (Littorina littorea), northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), sand gaper (Mya arenaria), blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), common cuttlefish (Sepia officinalis), stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), pullet carpet shell (Venerupis pullastra), warty venus (Venus verrucosa)

Infection with white spot syndrome virus

C+D+E

All decapod crustaceans (order Decapoda)

Penshells (Atrina spp.), common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), eastern oyster (Crassostrea virginica), wedge shell (Donax trunculus), Ezo abalone (Haliotis discus hannai), tuberculate abalone (Haliotis tuberculata), periwinkles (Littorina littorea), northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), sand gaper (Mya arenaria), blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), common cuttlefish (Sepia officinalis), stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), pullet carpet shell (Venerupis pullastra), warty venus (Venus verrucosa)


4.12.2018   

EN

Official Journal of the European Union

L 308/30


COMMISSION IMPLEMENTING REGULATION (EU) 2018/1883

of 3 December 2018

amending Regulation (EU) No 468/2010 establishing the EU list of vessels engaged in illegal, unreported and unregulated fishing

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (1), and in particular Article 30 thereof,

Whereas:

(1)

Chapter V of Regulation (EC) No 1005/2008 lays down procedures for the identification of fishing vessels engaged in illegal, unreported and unregulated fishing (‘IUU’) as well as procedures for establishing a Union list of such vessels (‘the Union list’). Article 37 of that Regulation provides for actions to be taken against fishing vessels included in that list.

(2)

The Union list was established by Commission Regulation (EU) No 468/2010 (2) and subsequently amended by Implementing Regulations (EU) No 724/2011 (3), (EU) No 1234/2012 (4), (EU) No 672/2013 (5), (EU) No 137/2014 (6), (EU) 2015/1296 (7), (EU) 2016/1852 (8) and (EU) 2017/2178 (9).

(3)

According to Article 30(1) of Regulation (EC) No 1005/2008, vessels included in the IUU vessel lists adopted by regional fisheries management organisations are to be included in the Union list.

(4)

All regional fishery management organisations provide for the establishment and regular up-date of IUU vessel lists in accordance with their respective rules (10).

(5)

According to Article 30 of Regulation (EC) No 1005/2008, upon the receipt from regional fisheries management organisations of the lists of fishing vessels presumed or confirmed to be involved in IUU fishing, the Commission is to update the Union list. Since the Commission has received new lists from the regional fisheries management organisations, the Union list should now be updated.

(6)

Considering that the same vessel might be listed under different names and/or flags depending on the time of its inclusion on the regional fisheries management organisations lists, the updated Union list should include the different names and/or flags as established by the relevant regional fisheries management organisations.

(7)

The vessels ‘Itziar II’ (11) and ‘Tchaw’ (12), which are currently included in the Union list, have been removed from the list established by the Commission for the Conservation of Antarctic Marine Living Resources (‘CCAMLR’), since they have been decommissioned. Those vessels should thus be removed from the Union list despite the fact that they have not yet been deleted from the list established by the General Fisheries Commission for the Mediterranean (‘GFCM’).

(8)

The vessel ‘Xin Shi Ji 16’ (13), which is currently included in the Union list, has been removed from the list established by the Inter-American Tropical Tuna Commission (‘IATTC’), in line with Resolution C-15-01 of that regional fisheries management organisation. This vessel should thus be removed from the Union list despite the fact that it has not yet been deleted from the list established by the International Commission for the Conservation of Atlantic Tunas (‘ICCAT’).

(9)

Regulation (EU) No 468/2010 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

HAS ADOPTED THIS REGULATION:

Article 1

Part B of the Annex to Regulation (EU) No 468/2010 is replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 December 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 286, 29.10.2008, p. 1.

(2)  OJ L 131, 29.5.2010, p. 22.

(3)  OJ L 194, 26.7.2011, p. 14.

(4)  OJ L 350, 20.12.2012, p. 38.

(5)  OJ L 193, 16.7.2013, p. 6.

(6)  OJ L 43, 13.2.2014, p. 47.

(7)  OJ L 199, 29.7.2015, p. 12.

(8)  OJ L 284, 20.10.2016, p. 5.

(9)  OJ L 307, 23.11.2017, p. 14.

(10)  Last updates: CCAMLR: NCP-IUU Vessel List adopted at 37th annual meeting CCAMLR-XXXVII, 22 October-2 November 2018; GFCM: IUU list adopted at 41st session, 16 October-20 October 2017; IATTC: 2017 list adopted at 93rd meeting of IATTC, 24 August, 27 August-30 August 2018; ICCAT: 2017 IUU list adopted at 25th meeting of the Commission, 14 November-21 November 2017; IOTC: IOTC IUU vessels list 2018, approved at 22nd session of the IOTC, 21 May-25 May 2018; NAFO: NAFO IUU List adopted at 40th annual meeting, 17 September-21 September 2018; NEAFC: IUU B list AM 2017-18 as adopted at 36th annual meeting, 13 November-17 November 2017; NPFC: NPFC IUU List adopted at 4th Commission meeting, 3 July-5 July 2018; SEAFO: SEAFO IUU vessel list adopted at 14th annual meeting of the Commission, 27 November-30 November 2017; SIOFA: SIOFA IUU Vessel List adopted at 5th Meeting of the Parties, 25 June-29 June 2018; SPRFMO: 2018 IUU vessel list adopted at 6th Commission meeting, 30 January-3 February 2018; WCPFC: WCPFC IUU vessel list for 2018, effective from 7 February 2018 adopted at 14th regular session of the Commission, 3 December-7 December 2017.

(11)  IMO ship identification number: 6803961.

(12)  IMO ship identification number: 6818930.

(13)  RFMO references: 20140001 [ICCAT] and 15579 [IATTC].


ANNEX

IMO (1) ship identification number/RFMO Reference

Vessel's name (2)

Flag State or Flag Territory (2)

Listed in RFMO (2)

20150046 [ICCAT]

ABUNDANT 1 (previous name according to ICCAT: YI HONG 6; previous name according to IOTC: YI HONG 06)

Unknown

IOTC, ICCAT

20150042 [ICCAT]

ABUNDANT 12 (previous name: YI HONG 106)

Unknown

IOTC, ICCAT

20150044 [ICCAT]

ABUNDANT 3 (previous name: YI HONG 16)

Unknown

IOTC, ICCAT

20170013 [ICCAT]

ABUNDANT 6 (previous name: YI HONG 86)

Unknown

IOTC, ICCAT

20150043 [ICCAT]

ABUNDANT 9 (previous name: YI HONG 116)

Unknown

IOTC, ICCAT

20060010 [ICCAT]

ACROS No. 2

Unknown (latest known flag: Honduras)

ICCAT, GFCM

20060009 [ICCAT]

ACROS No. 3

Unknown (latest known flag: Honduras)

ICCAT, GFCM

N/A

AL'AMIR MUHAMMAD

Egypt

GFCM

7306570

ALBORAN II (previous name according to NAFO, NEAFC: WHITE ENTERPRISE; previous names according to SEAFO, GFCM: WHITE, ENTERPRISE, ENXEMBRE, ATALAYA, REDA IV, ATALAYA DEL SUR)

Unknown [according to NAFO, NEAFC, SEAFO], Panama [according to GFCM] (latest known flags according to NAFO, NEAFC, SEAFO: Panama, Saint Kitts and Nevis)

NEAFC, NAFO, SEAFO, GFCM

7036345

AMORINN (previous names according to CCAMLR, GFCM: ICEBERG II, LOME, NOEMI)

Unknown [according to CCAMLR, GFCM] (latest known flags according to CCAMLR: Togo, Belize)

CCAMLR, SEAFO, GFCM

7236634

ANTONY (previous names according to CCAMLR: URGORA, ATLANTIC OJI MARU No. 33, OJI MARU No. 33)

Unknown [according to CCAMLR] (latest known flags according to CCAMLR: Indonesia, Belize, Panama, Honduras, Venezuela)

CCAMLR, SEAFO

2015001 [ICCAT]

ANEKA 228

Unknown

IOTC, ICCAT

2015002 [ICCAT]

ANEKA 228; KM.

Unknown

IOTC, ICCAT

7322897/20150024 [ICCAT]

ASIAN WARRIOR [according to CCAMLR, SEAFO], KUNLUN [according to ICCAT, IOTC], HUANG HE 22 [according to GFCM] (previous names according to CCAMLR: KUNLUN, TAISHAN, CHANG BAI, HONGSHUI, HUANG HE 22, SIMA QIAN BARU 22, CORVUS, GALAXY, INA MAKA, BLACK MOON, RED MOON, EOLO, THULE, MAGNUS, DORITA; previous name according to ICCAT, IOTC: TAISHAN; previous names according to GFCM: SIMA QIAN BARU 22, DORITA, MAGNUS, THULE, EOLO, RED MOON, BLACK MOON, INA MAKA, GALAXY, CORVUS)

Saint Vincent and the Grenadines [according to CCAMLR, SEAFO], Equatorial Guinea [according to ICCAT, IOTC] (latest known flags according to CCAMLR: Indonesia, Tanzania, North Korea (DPRK), Panama, Sierra Leone, Equatorial Guinea, Saint Vincent and the Grenadines, Uruguay)

CCAMLR, SEAFO, GFCM, IOTC, ICCAT

9042001 [CCAMLR, SEAFO, GFCM]/90420011 [IOTC]/20150047 [ICCAT]

ATLANTIC WIND [according to CCAMLR, SEAFO] SHAANXI HENAN 33 [according to GFCM], YONGDING [according to ICCAT, IOTC] (previous names according to CCAMLR: ZEMOUR 2, LUAMPA, YONGDING, JIANGFENG, CHENGDU, SHAANXI HENAN 33, XIONG NU BARU 33, DRACO I, LIBERTY, CHILBO SAN 33, HAMMER, SEO YANG No. 88, CARRAN; previous names according to GFCM: XIONG NU BARU 33, LIBERTY, CHILBO SAN 33, HAMMER, CARRAN, DRACO-1; previous name according to ICCAT, IOTC: JIANGFENG)

Unknown [according to CCAMLR], Equatorial Guinea [according to ICCAT, IOTC], Tanzania [according to GFCM] (latest known flags according to CCAMLR: Tanzania, Equatorial Guinea, Indonesia, Tanzania, Cambodia, Panama, Sierra Leone, North Korea (DPRK), Togo, Republic of Korea, Uruguay)

CCAMLR, SEAFO, GFCM, IOTC, ICCAT

9037537

BAROON [according to CCAMLR, SEAFO], LANA [according to GFCM] (previous names according to CCAMLR: LANA, ZEUS, TRITON I; previous names according to GFCM: ZEUS, TRITON-1, KINSHO MARU No. 18)

Tanzania [according to CCAMLR, SEAFO], Unknown [according to GFCM] (latest known flags according to CCAMLR: Nigeria, Mongolia, Togo, Sierra Leone)

CCAMLR, SEAFO, GFCM

2017003 [ICCAT]

BENAIAH

India

IOTC, ICCAT

2017004 [ICCAT]

BEO HINGIS

India

IOTC, ICCAT

12290 [IATTC]/20110011 [ICCAT]

BHASKARA No. 10

Unknown (latest known flag according to IATTC, ICCAT: Indonesia)

IATTC, ICCAT, GFCM

12291 [IATTC]/20110012 [ICCAT]

BHASKARA No. 9

Unknown (latest known flag according to IATTC, ICCAT: Indonesia)

IATTC, ICCAT, GFCM

20060001 [ICCAT]

BIGEYE

Unknown

ICCAT, GFCM

20040005 [ICCAT]

BRAVO

Unknown

ICCAT, GFCM

9407 [IATTC]/20110013 [ICCAT]

CAMELOT

Unknown (latest known flag according to IATTC: Belize)

IATTC, ICCAT, GFCM

7330399

CAPE FLOWER (previous name according to NEAFC, SEAFO: CAPE WRATH II)

Bolivia (latest known flags according to NEAFC, SEAFO: Sao Tome and Principe, South Africa, Panama, Canada)

NEAFC, SEAFO

2017005 [ICCAT]

CARMAL MATHA

India

IOTC, ICCAT

71 [IOTC]

CHAICHANACHOKE 8

Unknown (latest known flags: Djibouti, Thailand)

IOTC

72 [IOTC]

CHAINAVEE 54

Unknown (latest known flags: Djibouti, Thailand)

IOTC

73 [IOTC]

CHAINAVEE 55

Unknown (latest known flags: Djibouti, Thailand)

IOTC

6622642

CHALLENGE (previous names according to CCAMLR: PERSEVERANCE, MILA; previous names according to GFCM: MILA, ISLA, MONTANA CLARA, PERSEVERANCE)

Unknown [according to CCAMLR], Panama [according to GFCM] (latest known flags according to CCAMLR: Panama, Equatorial Guinea, United Kingdom)

CCAMLR, SEAFO, GFCM

20150003 [ICCAT]

CHI TONG

Unknown

IOTC, ICCAT

125 [IATTC]/20110014 [ICCAT]

CHIA HAO No. 66

Unknown (latest known flag according to IATTC: Belize; latest known flag according to ICCAT: Belize/Equatorial Guinea)

IATTC, ICCAT, GFCM

7913622

DAMANZAIHAO (previous name: LAFAYETTE)

Peru (latest known flag: Russia)

SPRFMO

20080001 [ICCAT]

DANIAA (previous name: CARLOS)

Unknown [according to ICCAT], Guinea [according to GFCM] (latest known flag according to ICCAT: Guinea)

ICCAT, GFCM

2017006 [ICCAT]

DIGNAMOL 1

India

IOTC, ICCAT

6163 [IATTC]/20130005 [ICCAT]

DRAGON III

Unknown (latest known flag according to IATTC: Cambodia)

IATTC, ICCAT, GFCM

2017007 [ICCAT]

EPHRAEEM

India

IOTC, ICCAT

8604668

EROS DOS (previous name: FURABOLOS)

Unknown [according to NAFO, NEAFC, SEAFO], Panama [according to GFCM] (latest known flags according to NAFO, NEAFC, SEAFO: Panama, Seychelles)

NEAFC, NAFO, SEAFO, GFCM

20150004 [ICCAT]

FU HSIANG FA 18

Unknown

IOTC, ICCAT

20150005 [ICCAT]

FU HSIANG FA No. 01

Unknown

IOTC, ICCAT

20150006 [ICCAT]

FU HSIANG FA No. 02

Unknown

IOTC, ICCAT

20150007 [ICCAT]

FU HSIANG FA No. 06

Unknown

IOTC, ICCAT

20150008 [ICCAT]

FU HSIANG FA No. 08

Unknown

IOTC, ICCAT

20150009 [ICCAT]

FU HSIANG FA No. 09

Unknown

IOTC, ICCAT

20150010 [ICCAT]

FU HSIANG FA No. 11

Unknown

IOTC, ICCAT

20150011 [ICCAT]

FU HSIANG FA No. 13

Unknown

IOTC, ICCAT

20150012 [ICCAT]

FU HSIANG FA No. 17

Unknown

IOTC, ICCAT

20150013 [ICCAT]

FU HSIANG FA No. 20

Unknown

IOTC, ICCAT

20150014 [ICCAT]

FU HSIANG FA No. 21

Unknown

IOTC, ICCAT

20130003 [ICCAT]

FU HSIANG FA No. 21 [according to ICCAT, IOTC], FU HSIANG FA [according to GFCM]

Unknown

IOTC, ICCAT, GFCM

20150015 [ICCAT]

FU HSIANG FA No. 23

Unknown

IOTC, ICCAT

20150016 [ICCAT]

FU HSIANG FA No. 26

Unknown

IOTC, ICCAT

20150017 [ICCAT]

FU HSIANG FA No. 30

Unknown

IOTC, ICCAT

7355662/20130001 [ICCAT]/M-01432 [WCPFC]

FU LIEN No. 1

Unknown [according to WCPFC], Unknow/Georgia [according to ICCAT], Georgia [according to GFCM] (latest known flag according to WCPFC, ICCAT: Georgia)

WCPFC, ICCAT, GFCM

20130004 [ICCAT]

FULL RICH

Unknown (latest known flag according to IOTC: Belize)

IOTC, ICCAT, GFCM

20080005 [ICCAT]

GALA I (previous names: MANARA II, ROAGAN)

Unknown (latest known flags according to ICCAT: Libya, Isle of Man)

ICCAT, GFCM

6591 [IATTC]/20130006 [ICCAT]

GOIDAU RUEY No. 1 (previous names according to IATTC, ICCAT: GOIDAU RUEY 1)

Unknown (latest known flag: Panama)

IATTC, ICCAT, GFCM

7020126

GOOD HOPE (previous name according to CCAMLR: TOTO; previous names according to GFCM: TOTO, SEA RANGER V)

Nigeria

CCAMLR, SEAFO, GFCM

6719419 [NEAFC, SEAFO]/6714919 [NAFO]

GORILERO (previous name: GRAN SOL)

Unknown (latest known flags according to GFCM, NAFO, NEAFC: Sierra Leone, Panama)

NEAFC, NAFO, SEAFO, GFCM

2009003 [ICCAT]

GUNUAR MELYAN 21

Unknown

IOTC, ICCAT, GFCM

13 [NPFC]

HAI DA 705

Unknown

NPFC

6607666

HAI LUNG [according to CCAMLR], RAY [according to NEAFC, GFCM], RAY/YELE [according to SEAFO] (previous names according to CCAMLR: YELE, RAY, KILY, CONSTANT, TROPIC, ISLA GRACIOSA; previous names according to NEAFC: KILLY, TROPIC, ISLA GRACIOSA, CONSTANT; previous names according to SEAFO: KILLY, TROPICS, ISLA, GRACIOSA, CONSTANT; previous names according to GFCM: KILLY, TROPIC, CONSTANT, ISLA RACIOSA)

Unknown [according to CCAMLR], Belize [according to NEAFC], Belize/Sierra Leone [according to SEAFO], Belize/Unknown [according to GFCM) (latest known flags according to CCAMLR: Sierra Leone, Belize, Equatorial Guinea, South Africa; latest known flags according to NEAFC: South Africa, Equatorial Guinea, Mongolia; latest known flags according to GFCM: Belize, Mongolia, Equatorial Guinea, South Africa)

CCAMLR, NEAFC, SEAFO, GFCM

7322926

HEAVY SEA (previous names according to CCAMLR: DUERO, JULIUS, KETA, SHERPA UNO; previous names according to GFCM: DUERO, KETA, SHERPA UNO)

Unknown [according to CCAMLR], Panama [according to GFCM] (latest known flags according to CCAMLR: Panama, Saint Kitts and Nevis, Belize)

CCAMLR, SEAFO, GFCM

20150018 [ICCAT]

HOOM XIANG 101

Unknown (latest known flag: Malaysia)

IOTC, ICCAT

20150019 [ICCAT]

HOOM XIANG 103

Unknown (latest known flag: Malaysia)

IOTC, ICCAT

20150020 [ICCAT]

HOOM XIANG 105

Unknown (latest known flag: Malaysia)

IOTC, ICCAT

20100004 [ICCAT]

HOOM XIANG II [according to ICCAT, IOTC], HOOM XIANG 11 [according to GFCM, ICCAT]

Unknown (latest known flag according to ICCAT, IOTC: Malaysia)

IOTC, ICCAT, GFCM

7332218

IANNIS 1 [according to NEAFC], IANNIS I [according to GFCM, NAFO, SEAFO] (previous names according to GFCM: MOANA MAR, CANOS DE MECA)

Unknown [according to NEAFC, NAFO, SEAFO], Panama/Unknown [according to GFCM] (latest known flag according to NAFO, NEAFC, SEAFO: Panama)

NEAFC, NAFO, SEAFO, GFCM

9505 [IATTC]/20130007 [ICCAT]

JYI LIH 88

Unknown

IATTC, ICCAT, GFCM

20150021 [ICCAT]

KIM SENG DENG 3

Bolivia [according to IOTC], Unknown [according to ICCAT] (latest known flag according to ICCAT: Bolivia)

IOTC, ICCAT

2017008 [ICCAT]

KING JESUS

India

IOTC, ICCAT

7905443

KOOSHA 4 (previous name according to GFCM: EGUZKIA)

Iran

CCAMLR, SEAFO, GFCM

20150022 [ICCAT]

KUANG HSING 127

Unknown

IOTC, ICCAT

20150023 [ICCAT]

KUANG HSING 196

Unknown

IOTC, ICCAT

7325746

LABIKO [according to NAFO, NEAFC, SEAFO], MAINE [according to GFCM] (previous names according to SEAFO: MAINE, CLAUDE MOINIER, CHEVALIER D'ASSAS; previous name according to NAFO, NEAFC: MAINE; previous names according to GFCM: MAPOSA NOVENO, GUINESPA I)

Unknown [according to NAFO, NEAFC, SEAFO], Guinea [according to GFCM] (latest known flag according to NAFO, NEAFC: Guinea)

NEAFC, NAFO, SEAFO, GFCM

1 [NPFC]

LIAO YUAN YU 071

Unknown

NPFC

2 [NPFC]

LIAO YUAN YU 072

Unknown

NPFC

3 [NPFC]

LIAO YUAN YU 9

Unknown

NPFC

20060007 [ICCAT]

LILA No. 10

Unknown (latest known flag: Panama)

ICCAT, GFCM

7388267

LIMPOPO (previous names according to CCAMLR: ROSS, ALOS, LENA, CAP GEORGE; previous names according to GFCM: ROSS, ALOS, LENA, CAP GEORGE, CONBAROYA, TERCERO)

Unknown (latest known flags according to CCAMLR: Togo, Ghana, Seychelles, France; latest known flags according to GFCM: Togo, Ghana, Seychelles)

CCAMLR, SEAFO, GFCM

14 [NPFC]

LU RONG YU 1189

Unknown

NPFC

24 [NPFC]

LU RONG YU 612

Unknown

NPFC

17 [NPFC]

LU RONG YUAN YU 101

Unknown

NPFC

18 [NPFC]

LU RONG YUAN YU 102

Unknown

NPFC

19 [NPFC]

LU RONG YUAN YU 103

Unknown

NPFC

20 [NPFC]

LU RONG YUAN YU 105

Unknown

NPFC

21 [NPFC]

LU RONG YUAN YU 106

Unknown

NPFC

22 [NPFC]

LU RONG YUAN YU 108

Unknown

NPFC

23 [NPFC]

LU RONG YUAN YU 109

Unknown

NPFC

25 [NPFC]

LU RONG YUAN YU 787

Unknown

NPFC

27 [NPFC]

LU RONG YUAN YU 797

Unknown

NPFC

26 [NPFC]

LU RONG YUAN YU YUN 958

Unknown

NPFC

20150025 [ICCAT]

MAAN YIH HSING

Unknown

IOTC, ICCAT

20040007 [ICCAT]

MADURA 2

Unknown

ICCAT, GFCM

20040008 [ICCAT]

MADURA 3

Unknown

ICCAT, GFCM

20060002 [ICCAT]

MARIA

Unknown

ICCAT, GFCM

20060005 [ICCAT]

MELILLA No. 101

Unknown (latest known flag: Panama)

ICCAT, GFCM

20060004 [ICCAT]

MELILLA No. 103

Unknown (latest known flag: Panama)

ICCAT, GFCM

7385174

MURTOSA

Unknown (latest known flag according to NAFO, NEAFC, SEAFO: Togo; latest known flags according to GFCM: Togo, Portugal)

NEAFC, NAFO, SEAFO, GFCM

9009918

MYS MARII

Russia

SPRFMO

M-00545 [WCPFC]/14613 [IATTC]/C-00545, 20110003 [ICCAT]

NEPTUNE

Unknown [according to WCPFC], Georgia [according to IATTC, GFCM], Georgia/Unknown [according to ICCAT] (latest known flag according to WCPFC, ICCAT: Georgia)

IATTC, ICCAT, WCPFC, GFCM

20160001 [ICCAT]

NEW BAI I No. 168 (previous name: SAMUDERA)

Unknown (latest known flags: Liberia, Indonesia)

ICCAT

20060003 [ICCAT]

No. 101 GLORIA (previous name: GOLDEN LAKE)

Unknown (latest known flag: Panama)

ICCAT, GFCM

20060008 [ICCAT]

No. 2 CHOYU

Unknown (latest known flag: Honduras)

ICCAT, GFCM

20060011 [ICCAT]

No. 3 CHOYU

Unknown (latest known flag: Honduras)

ICCAT, GFCM

8808903

NORTHERN WARRIOR (previous names according to CCAMLR: MILLENNIUM, SIP 3)

Angola [according to CCAMLR, SEAFO] (last known flags according to CCAMLR: Curacao, Netherlands Antilles, South Africa, Belize, Morocco)

CCAMLR, SEAFO

20040006 [ICCAT]

OCEAN DIAMOND

Unknown

ICCAT, GFCM

7826233/20090001 [ICCAT]

OCEAN LION

Unknown (latest known flag: Equatorial Guinea)

IOTC, ICCAT, GFCM

7816472

OKAPI MARTA

Belize

GFCM

11369 [IATTC]/20130008 [ICCAT]

ORCA

Unknown (latest known flag: Belize)

IATTC, ICCAT, GFCM

20060012 [ICCAT]

ORIENTE No. 7

Unknown (latest known flag: Honduras)

ICCAT, GFCM

5062479

PERLON (previous names according to CCAMLR: CHERNE, BIGARO, HOKING, SARGO, LUGALPESCA; previous names according to GFCM: CHERNE, SARGO, HOKING, BIGARO, UGALPESCA)

Unknown [according to CCAMLR, GFCM] (latest known flags according to CCAMLR, GFCM: Mongolia, Togo, Uruguay)

CCAMLR, SEAFO, GFCM

9319856/20150033 [ICCAT]

PESCACISNE 1/PESCACISNE 2 [according to CCAMLR], ZEMOUR 1 [according to SEAFO], SONGHUA [according to ICCAT, IOTC], HUIQUAN/WUTAISHAN ANHUI 44 [according to GFCM], (previous names according to CCAMLR: ZEMOUR 1, KADEI, SONGHUA, YUNNAN, NIHEWAN, HUIQUAN, WUTAISHAN ANHUI 44, YANGZI HUA 44, TROSKY, PALOMA V; previous name according to SEAFO: SONGHUA; previous name according to ICCAT, IOTC: YUNNAN; preivous names according to GFCM: WUTAOSHAN ANHUI 44, YANGZI HUA 44, TROSKY, PALOMA V, JIAN YUAN)

Unknown [according to CCAMLR, IOTC], Mauritania [according to SEAFO], Tanzania/Unknown [according to GFCM], Unknow/Equatorial Guinea [according to ICCAT] (lastest known flags according to CCAMLR: Mauritania, Equatorial Guinea, Indonesia, Tanzania, Mongolia, Cambodia, Namibia, Uruguay; lastest known flag according to ICCAT, IOTC: Equatorial Guinea)

CCAMLR, SEAFO, GFCM, ICCAT, IOTC

95 [IATTC]/20130009 [ICCAT]

REYMAR 6

Unknown (latest known flag: Belize)

IATTC, ICCAT, GFCM

2017009 [ICCAT]

SACRED HEART

India

IOTC, ICCAT

20130013 [ICCAT]

SAMUDERA PASIFIK No. 18 (previous names according to ICCAT: KAWIL No. 03, LADY VI-T-III)

Indonesia

ICCAT, GFCM

20150026 [ICCAT]

SAMUDERA PERKASA 11

Unknown

IOTC, ICCAT

20150027 [ICCAT]

SAMUDRA PERKASA 12 [according to IOTC], SAMUDERA PERKASA 12 [according to ICCAT]

Unknown

IOTC, ICCAT

7424891

SEA URCHIN [according to CCAMLR], ALDABRA [according to GFCM, SEAFO] (previous names according to CCAMLR: ALDABRA, OMOA I; previous name according to GFCM: OMOA I)

Gambia [according to CCAMLR], Tanzania [according to GFCM] (lastest known flags according to CCAMLR: Tanzania, Honduras)

CCAMLR, SEAFO, GFCM

20170010 [ICCAT]

SHALOM

India

IOTC, ICCAT

20080004 [ICCAT]

SHARON 1 (previous names according to GFCM: MANARA I, POSEIDON; previous names according to ICCAT: MANARA 1, POSEIDON)

Unknown (latest known flag according to GFCM: Libya; latest known flags according to ICCAT: Libya, United Kingdom)

ICCAT, GFCM

20170014 [ICCAT]

SHENG JI QUN 3

Unknown

IOTC, ICCAT

20150028 [ICCAT]

SHUEN SIANG

Unknown

IOTC, ICCAT

20170015 [ICCAT]

SHUN LAI (previous name: HSIN JYI WANG No. 6)

Unknown

IOTC, ICCAT

20150029 [ICCAT]

SIN SHUN FA 6

Unknown

IOTC, ICCAT

20150030 [ICCAT]

SIN SHUN FA 67

Unknown

IOTC, ICCAT

20150031 [ICCAT]

SIN SHUN FA 8

Unknown

IOTC, ICCAT

20150032 [ICCAT]

SIN SHUN FA 9

Unknown

IOTC, ICCAT

20050001 [ICCAT]

SOUTHERN STAR 136 (previous name: HSIANG CHANG)

Unknown (latest known flag: Saint Vincent and the Grenadines)

ICCAT, GFCM

20150034 [ICCAT]

SRI FU FA 168

Unknown

IOTC, ICCAT

20150035 [ICCAT]

SRI FU FA 18

Unknown

IOTC, ICCAT

20150036 [ICCAT]

SRI FU FA 188

Unknown

IOTC, ICCAT

20150037 [ICCAT]

SRI FU FA 189

Unknown

IOTC, ICCAT

20150038 [ICCAT]

SRI FU FA 286

Unknown

IOTC, ICCAT

20150039 [ICCAT]

SRI FU FA 67

Unknown

IOTC, ICCAT

20150040 [ICCAT]

SRI FU FA 888

Unknown

IOTC, ICCAT

8514772

STS-50 [according to CCAMLR], AYADA [according to SEAFO] (previous names according to CCAMLR: AYDA, SEA BREEZE, ANDREY DOLGOV, STD No. 2, SUN TAI No. 2, SHINSEI MARU No. 2)

Togo [according to CCAMLR, SEAFO] (lastest known flags according to CCAMLR: Cambodia, Republic of Korea, Philippines, Japan, Namibia)

CCAMLR, SEAFO

74 [IOTC]

SUPPHERMNAVEE 21

Unknown (latest known flags: Djibouti, Thailand)

IOTC

9405 [IATTC]/20130010 [ICCAT]

TA FU 1

Unknown (latest known flag according to IATTC: Belize)

IATTC, ICCAT, GFCM

9179359

TAVRIDA (previous names: AURORA, PACIFIC CONQUEROR)

Russia (latest known flag: Peru)

SPRFMO

13568 [IATTC]/20130011 [ICCAT]

TCHING YE No. 6 (previous name according to ICCAT, GFCM: EL DIRIA I)

Unknown (latest known flag according to IATTC, GFCM: Belize; latest known flags according to ICCAT: Belize, Costa Rica)

IATTC, ICCAT, GFCM

20150041 [ICCAT]

TIAN LUNG No.12

Unknown

IOTC, ICCAT

7321374

TRINITY [according to NEAFC, NAFO, SEAFO], TRINITY/YUCATAN BASIN [according to GFCM] (previous names according to NAFO: YUCUTAN BASIN, ENXEMBRE, FONTE NOVA, JAWHARA; previous names according to NEAFC: ENXEMBRE, YUCUTAN BASIN, FONTENOVA, JAWHARA; previous names according to SEAFO: YUCUTAN BASIN, FONTE NOVA, JAWHARA; previous names according to GFCM: YUCATAN BASIN, EXEMBRE/ENXEMBRE, FONTENOVA, JAWHARA)

Unknown [according to NAFO, NEAFC], Ghana [according to GFCM, SEAFO] (latest known flags according to NAFO: Ghana, Panama; latest known flags according to NEAFC: Ghana, Panama, Morocco)

NEAFC, NAFO, SEAFO, GFCM

20170011 [ICCAT]

VACHANAM

India

IOTC, ICCAT

8994295/129 [IATTC]/20130012 [ICCAT]

WEN TENG No. 688/MAHKOIA ABADI No. 196 [according to IATTC, GFCM], WEN TENG No. 688 [according to ICCAT] (previous name according to ICCAT: MAHKOIA ABADI No. 196)

Unknown (latest known flag: Belize)

IATTC, ICCAT, GFCM

20170012 [ICCAT]

WISDOM

India

IOTC, ICCAT

7637527

WISDOM SEA REEFER

Honduras

IOTC

20150045 [ICCAT]

YI HONG 3

Unknown

IOTC, ICCAT

20130002 [ICCAT]

YU FONG 168

Chinese Taipei [according to GFCM, ICCAT] Unknown [according to WCPFC] (latest known flag according to WCPFC: Chinese Taipei)

WCPFC, ICCAT, GFCM

20150048 [ICCAT]

YU FONG 168

Unknown

IOTC, ICCAT

2009002 [ICCAT]

YU MAAN WON

Unknown (latest known flag: Georgia)

IOTC, ICCAT, GFCM

20170016 [ICCAT]

YUTUNA 3 (previous name: HUNG SHENG No. 166)

Unknown

IOTC, ICCAT

20170017 [ICCAT]

YUTUNA No.1

Unknown

IOTC, ICCAT

15 [NPFC]

ZHE LING YU LENG 90055

Unknown

NPFC

16 [NPFC]

ZHE LING YU LENG 905

Unknown

NPFC

4 [NPFC]

ZHOU YU 651

Unknown

NPFC

5 [NPFC]

ZHOU YU 652

Unknown

NPFC

6 [NPFC]

ZHOU YU 653

Unknown

NPFC

7 [NPFC]

ZHOU YU 656

Unknown

NPFC

8 [NPFC]

ZHOU YU 657

Unknown

NPFC

9 [NPFC]

ZHOU YU 658

Unknown

NPFC

10 [NPFC]

ZHOU YU 659

Unknown

NPFC

11 [NPFC]

ZHOU YU 660

Unknown

NPFC

12 [NPFC]

ZHOU YU 661

Unknown

NPFC


(1)  International Maritime Organization.

(2)  For any additional information consult the websites of the regional fisheries management organisations (RFMOs).


DECISIONS

4.12.2018   

EN

Official Journal of the European Union

L 308/41


COUNCIL DECISION (CFSP) 2018/1884

of 3 December 2018

extending and amending Decision 2010/452/CFSP on the European Union Monitoring Mission in Georgia, EUMM Georgia

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Articles 42(4) and 43(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 12 August 2010 the Council adopted Decision 2010/452/CFSP (1), which extended the European Union Monitoring Mission in Georgia (EUMM Georgia), established by Council Joint Action 2008/736/CFSP (2).

(2)

On 12 December 2016 the Council adopted Decision (CFSP) 2016/2238 (3), extending the mandate of EUMM Georgia until 14 December 2018 and providing for a financial reference amount until 14 December 2017.

(3)

On 7 December 2017 the Council adopted Decision (CFSP) 2017/2263 (4), providing for a financial reference amount until 14 December 2018.

(4)

Following the 2018 strategic review, the Political and Security Committee recommended that the mandate of EUMM Georgia be extended until 14 December 2020.

(5)

Decision 2010/452/CFSP should be amended accordingly.

(6)

EUMM Georgia will be conducted in the context of a situation which may deteriorate and could impede the achievement of the objectives of the Union's external action as set out in Article 21 of the Treaty,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2010/452/CFSP is amended as follows:

(1)

in Article 14(1), the following subparagraph is added:

‘The financial reference amount intended to cover the expenditure related to the Mission between 15 December 2018 and 14 December 2020 shall be EUR 38 200 000.’;

(2)

in Article 18, the second paragraph is replaced by the following:

‘It shall expire on 14 December 2020.’.

Article 2

This Decision shall enter into force on the date of its adoption.

It shall apply from 15 December 2018.

Done at Brussels, 3 December 2018.

For the Council

The President

N. HOFER


(1)  Council Decision 2010/452/CFSP of 12 August 2010 on the European Union Monitoring Mission in Georgia, EUMM Georgia (OJ L 213, 13.8.2010, p. 43).

(2)  Council Joint Action 2008/736/CFSP of 15 September 2008 on the European Union Monitoring Mission in Georgia, EUMM Georgia (OJ L 248, 17.9.2008, p. 26).

(3)  Council Decision (CFSP) 2016/2238 of 12 December 2016 amending Decision 2010/452/CFSP on the European Union Monitoring Mission in Georgia, EUMM Georgia (OJ L 337, 13.12.2016, p. 15).

(4)  Council Decision (CFSP) 2017/2263 of 7 December 2017 amending Decision 2010/452/CFSP on the European Union Monitoring Mission in Georgia, EUMM Georgia (OJ L 324, 8.12.2017, p. 51).


4.12.2018   

EN

Official Journal of the European Union

L 308/43


COMMISSION IMPLEMENTING DECISION (EU, Euratom) 2018/1885

of 30 November 2018

amending Decision 96/566/Euratom, EC authorising Finland not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base

(notified under document C(2018) 7840)

(Only the Finnish and Swedish texts are authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to the Treaty establishing the European Atomic Energy Community,

Having regard to Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (1), and in particular the second indent of Article 6(3) thereof,

After consulting the Advisory Committee on Own Resources,

Whereas:

(1)

Under Article 379(2) of Council Directive 2006/112/EC (2), Finland may, in accordance with the conditions applying in that Member State on the date of its accession, continue to exempt the supply of services by authors, artists and performers, listed in point 2 of Part B of Annex X, and the transactions listed in points 9 and 10 of Part B of Annex X to that Directive, for as long as the same exemptions are applied in any of the Member States which were members of the Community on 31 December 1994. In accordance with that Article, those transactions are to be taken into account for the determination of the value added tax (VAT) own resources base.

(2)

By Commission Decision 96/566/Euratom, EC (3), Finland was authorised to, inter alia, use approximate estimates to calculate the VAT own resources base in respect of transactions now referred to in points 2, 9 and 10 of Part B of Annex X to Directive 2006/112/EC regarding certain services supplied by authors, artists, performers, certain supplies of land and the transport of passengers.

(3)

In its letter of 26 April 2018, Finland requested an authorisation from the Commission to use fixed percentages of the intermediate base for the calculation of the VAT own resources base for transactions referred to in points 2, 9 and 10 of Part B of Annex X to Directive 2006/112/EC regarding the supply of services by the liberal professions, the supply of new buildings or the lands on which they stand, the supply of building land and the transport of passengers. Finland has shown that the percentages applied to the intermediate base have been stable for the years 2014 to 2016 (points 2 and 10) and 2012 to 2016 (point (9). Authorisation to use fixed percentages would further reduce the administrative burden in calculating the VAT own resources base for such transactions. Finland should therefore be authorised to calculate the VAT own resources base using fixed percentages regarding the supply of services by the liberal professions, the supply of new buildings or the lands on which they stand, the supply of building land and the transport of passengers.

(4)

For reasons of transparency and legal certainty, it is appropriate to limit the applicability of the authorisation in time.

(5)

Decision 96/566/Euratom, EC should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Decision 96/566/Euratom, EC the following Articles 2a, 2b and 2c are inserted:

‘Article 2a

By way of derogation from Article 2(1) of this Decision, for the purpose of calculating the VAT own resources base from 1 January 2018 to 31 December 2020, Finland is authorised to use 0,0002 % of the intermediate base in respect of transactions referred to in point 2 of Part B of Annex X to Council Directive 2006/112/EC (*1).

Article 2b

By way of derogation from Article 2(2) of this Decision, for the purpose of calculating the VAT own resources base from 1 January 2018 to 31 December 2020, Finland is authorised to use 0,53 % of the intermediate base in respect of transactions referred to in point 9 of Part B of Annex X to Directive 2006/112/EC.

Article 2c

By way of derogation from Article 2(3) of this Decision, for the purpose of calculating the VAT own resources base from 1 January 2018 to 31 December 2020, Finland is authorised to use 0,11 % of the intermediate base in respect of transactions referred to in point 10 of Part B of Annex X to Directive 2006/112/EC.

Article 2

This Decision is addressed to the Republic of Finland.

Done at Brussels, 30 November 2018.

For the Commission

Günther OETTINGER

Member of the Commission


(1)  OJ L 155, 7.6.1989, p. 9.

(2)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

(3)  Commission Decision 96/566/Euratom, EC of 11 September 1996 authorising Finland not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (OJ L 247, 28.9.1996, p. 43).


4.12.2018   

EN

Official Journal of the European Union

L 308/45


COMMISSION IMPLEMENTING DECISION (EU, Euratom) 2018/1886

of 30 November 2018

amending Decision 90/184/Euratom, EEC authorising Denmark not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base

(notification under document C(2018) 7854)

(Only the Danish text is authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to the Treaty establishing the European Atomic Energy Community,

Having regard to Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (1), and in particular the first indent of Article 6(3) thereof,

After consulting the Advisory Committee on Own Resources,

Whereas:

(1)

Under Article 371 of Council Directive 2006/112/EC (2), Denmark may, in accordance with the conditions applying in that Member State on 1 January 1978, continue to exempt the transactions listed in Part B of Annex X to that Directive. In accordance with that Article, those transactions are to be taken into account for the determination of the value added tax (VAT) own resources base.

(2)

By Commission Decision 90/184/Euratom, EEC (3), Denmark was authorised, inter alia, not to take into account transactions now referred to in point 2 of Part B of Annex X to Directive 2006/112/EC, namely services supplied by authors, artists and performers in order to calculate the VAT own resources base. However, subsequently by Commission Implementing Decision 2012/814/EU (4), Euratom this authorisation was repealed.

(3)

In 2012, the Commission carried out a review exercise of authorisations granted to Member States in order to remove those which were no longer required. As part of that exercise, Denmark inadvertently omitted to include the authorisation in respect of those transactions referred to in point 2 of Part B of Annex X to Directive 2006/112/EC in a list of authorisations furnished to the Commission. The Commission interpreted this omission as an implicit confirmation by Denmark that the authorisation could be repealed and it subsequently adopted Implementing Decision 2012/814/EU deleting the authorisation granted in Article 1 of Decision 90/184/Euratom, EEC. If the Commission had been in possession of correct information, that authorisation would not have been deleted.

(4)

In its letter of 30 April 2018, Denmark stated that the authorisation granted in Decision 90/184/Euratom, EEC was repealed due to a misunderstanding. Implementing Decision 2012/814/EU, Euratom incorrectly recited that Denmark taxed those transactions referred to in point 2 of Part B of Annex X to Directive 2006/112/EC, and that therefore the authorisation granted by Decision 90/184/Euratom, EEC should be repealed. However, Denmark has confirmed that it has never taxed the supply of services by authors, artists and performers and these supplies belong to the transactions referred to in point 2 of Part B of Annex X to Directive 2006/112/EC, which Member States may continue to exempt. Given that the basis for the repeal of the authorisation never in fact existed, Denmark requests the Commission to reinstate the authorisation granted in Decision 90/184/Euratom, EEC.

(5)

On the basis of an analysis of the documents submitted by Denmark in 2012 and based on information received from Denmark in 2018, the Commission considers that the authorisation should be reinstated in order to correct the terms of Decision 90/184/Euratom, EEC and that it should apply from that date.

(6)

For reasons of transparency and legal certainty, it is appropriate to limit the applicability of this authorisation in time.

(7)

Decision 90/184/Euratom, EEC should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Decision 90/184/Euratom, EEC the following Article 2a is inserted:

‘Article 2a

For the purposes of calculating the VAT own resources base from 20 December 2012 to 31 December 2022, Denmark is authorised not to take into account the transactions referred to in Point 2 of Part B of Annex X to Council Directive 2006/112/EC (*1) insofar as they apply to services supplied by authors, artists and performers.

Article 2

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 30 November 2018.

For the Commission

Günther OETTINGER

Member of the Commission


(1)  OJ L 155, 7.6.1989, p. 9.

(2)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

(3)  Commission Decision 90/184/Euratom, EEC of 23 March 1990 authorising Denmark not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (OJ L 99, 19.4.1990, p. 37).

(4)  Commission Implementing Decision 2012/814/EU, Euratom of 19 December 2012 amending Decision 90/184/Euratom, EEC authorising Denmark not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (OJ L 352, 21.12.2012, p. 56).


4.12.2018   

EN

Official Journal of the European Union

L 308/47


COMMISSION IMPLEMENTING DECISION (EU, Euratom) 2018/1887

of 30 November 2018

amending Decision 90/176/Euratom, EEC authorising France not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base

(notified under document C(2018) 7866)

(Only the French text is authentic)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to the Treaty establishing the European Atomic Energy Community,

Having regard to Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (1), and in particular the second indent of Article 6(3) thereof,

After consulting the Advisory Committee on Own Resources,

Whereas:

(1)

Under Article 371 of Council Directive 2006/112/EC (2), France may, in accordance with the conditions applying in that Member State on 1 January 1978, continue to exempt the transactions listed in Part B of Annex X to that Directive. In accordance with that Article, those transactions are to be taken into account for the determination of the value added tax (VAT) own resources base.

(2)

By Commission Decision 90/176/Euratom, EEC (3), France was authorised to, inter alia, use approximate estimates to calculate the VAT own resources base in respect of, inter alia, transactions now referred to in point 8 of Part B of Annex X to Directive 2006/112/EC regarding the supply of water by public authorities.

(3)

In its letter of 26 April 2018, France requested an authorisation from the Commission to use a fixed percentage of the intermediate base for the calculation of the VAT own resources base for transactions referred to in point 8 of Part B of Annex X to Directive 2006/112/EC regarding the supply of water by public authorities. France has shown that the percentage applied to the intermediate base has been stable for the years 2012 to 2016. Authorisation to use fixed percentages would further reduce the administrative burden in calculating the VAT own resources base for such transactions. France should therefore be authorised to calculate the VAT own resources base using a fixed percentage regarding the supply of water by a body governed by public law.

(4)

For reasons of transparency and legal certainty, it is appropriate to limit the applicability of the authorisation in time.

(5)

Decision 90/176/Euratom, EEC should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Decision 90/176/Euratom, EEC the following Article 2c is inserted:

‘Article 2c

By way of derogation from Article 2(3) of this Decision, for the purpose of calculating the VAT own resources base from 1 January 2018 to 31 December 2020, France is authorised to use 0,02 % of the intermediate base in respect of transactions referred to in point 8 of Part B of Annex X to Directive 2006/112/EC.’

Article 2

This Decision is addressed to the French Republic.

Done at Brussels, 30 November 2018.

For the Commission

Günther OETTINGER

Member of the Commission


(1)  OJ L 155, 7.6.1989, p. 9.

(2)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

(3)  Commission Decision 90/176/Euratom, EEC of 23 March 1990 authorising France not to take into account certain categories of transactions and to use certain approximate estimates for the calculation of the VAT own resources base (OJ L 99, 19.4.1990, p. 22).


4.12.2018   

EN

Official Journal of the European Union

L 308/49


COMMISSION IMPLEMENTING DECISION (EU) 2018/1888

of 3 December 2018

determining that a temporary suspension of the preferential customs duty pursuant to Article 15 of Regulation (EU) No 19/2013 of the European Parliament and of the Council and pursuant to Article 15 of Regulation (EU) No 20/2013 of the European Parliament and of the Council is not appropriate for imports of bananas originating in Guatemala and Peru

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 19/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Trade Agreement between the European Union and its Member States, of the one part, and Colombia, Peru and Ecuador of the other part (1), and in particular Article 15(2) thereof,

Having regard to Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013, implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (2), and in particular Article 15(2) thereof,

Whereas:

(1)

A stabilisation mechanism for bananas has been introduced by the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America, on the other hand. A similar mechanism was included in the Trade Agreement between the European Union and its Member States, of the one part, and Colombia, Peru and Ecuador, of the other part. These Agreements (‘the Agreements’), provisionally started to apply for Guatemala on 1 August 2013 and for Peru on 1 March 2013.

(2)

According to these stabilisation mechanisms, as implemented by Regulation (EU) No 20/2013 and by Regulation (EU) No 19/2013, once a defined trigger volume is exceeded for imports of fresh bananas (3) from one of the countries concerned, the Commission may either temporarily suspend the preferential customs duty applied to imports of fresh bananas for that country or determine that such suspension is not appropriate. This should be done by an implementing act to be adopted in accordance with the urgency procedure laid down in Article 14(4) of Regulation (EU) No 20/2013 and in Article 14(4) of Regulation (EU) No 19/2013.

(3)

On 10 September and 15 October 2018, imports into the Union of fresh bananas originating in Guatemala and Peru exceeded their trigger volume of respectively 70 000 tonnes and 97 500 tonnes, as defined by the respective relevant Agreements.

(4)

In this context, pursuant to Article 15(3) of Regulation (EU) No 20/2013 and pursuant to Article 15(3) of Regulation (EU) No 19/2013, the Commission analysed the impact of the imports concerned on the situation of the Union market for bananas in order to decide whether or not the preferential customs duty should be suspended. The Commission has examined the effect of the imports concerned on the Union price level, the development of imports from other sources and the overall stability of the Union market for fresh bananas.

(5)

On 15 October 2018 imports of fresh bananas from Guatemala and Peru represented 2,95 % and 2,80 % of the imports to the Union of fresh bananas subject to the stabilisation mechanism. Furthermore, Guatemala and Peru represented respectively 1,8 % and 2,2 % of the total imports of fresh bananas into the Union.

(6)

At the same time, imports from large exporting countries also subject to the stabilisation mechanism, notably Colombia, Ecuador and Costa Rica amounted to respectively 51 %, 64,3 % and 64,3 % of their thresholds. The ‘unused’ quantities under the stabilisation mechanism (approximately 2,4 million tonnes) are therefore significantly higher than the total imports from Guatemala and Peru (105 366 and 99 698 tonnes).

(7)

The import prices from Guatemala and Peru were on average 527 EUR/tonne and 730 EUR/tonne for the first 8 months of 2018 (last available data), which is respectively 20 % lower and 10,7 % higher than the average prices of the other imports of fresh bananas into the Union.

(8)

In this context, despite the low price of bananas imported from Guatemala, the average wholesale banana price on the Union market in July 2018, did not register any downward change and remained high. Indeed, the average wholesale price for bananas (of all origins) amounted to 911,5 EUR/tonne in August 2018, which is 2,8 % higher than the corresponding price in August 2017 (855,3 EUR/tonne). Furthermore, the average wholesale price of Union produced bananas was 1 228,6 EUR/tonne in August 2018, which is 38,9 % higher than the level in August 2017 (884,6 EUR/tonne). This is also despite the fact that imports from Nicaragua have now exceeded their threshold by 409 %.

(9)

Given the fact that the imports of bananas from Guatemala and Peru are respectively small, they have not had an impact on the Union banana market price. There is thus at this stage neither an indication that the stability of the Union market has been disturbed by the imports of fresh bananas from Guatemala and Peru in excess of the defined annual trigger import volume, nor that these had a significant impact on the situation of Union producers.

(10)

There is moreover no indication of threat of serious deterioration in the Union market or of serious deterioration in the economic situation of the outermost regions of the Union in August 2018.

(11)

Therefore, the suspension of the preferential customs duty on imports of bananas originating in Guatemala and Peru is not appropriate at this stage.

(12)

The Commission will continue its monitoring in this regard and may adopt measures if appropriate,

HAS ADOPTED THIS DECISION:

Article 1

The temporary suspension of preferential customs duty on imports of fresh bananas classified under subheading 0803 90 10 of the European Union Combined Nomenclature and originating in Guatemala and or Peru is not appropriate.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 3 December 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 17, 19.1.2013, p. 1.

(2)  OJ L 17, 19.1.2013, p. 13.

(3)  Subheading 0803 90 10 of the European Union Combined Nomenclature of 11 October 2018.


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