(1)

Table 3.1 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions on those proposals issued by the Committee for Risk Assessment of the Agency (RAC), as well as on the comments received from the parties concerned, it is appropriate to introduce, update or delete harmonised classification and labelling of certain substances.

(3)

Council Directive 67/548/EEC (2) and Directive 1999/45/EC of the European Parliament and of the Council (3) were repealed with effect from 1 June 2015. As a result, Part 3 of Annex VI to Regulation (EC) No 1272/2008 was amended by Commission Regulation (EU) 2016/1179 (4) to remove Table 3.2. That amendment took effect on 1 June 2017. Annex VI to Regulation (EC) No 1272/2008 was further amended by Commission Regulation (EU) 2017/776 (5) to delete references to Table 3.2, to convert references to Table 3.1 into references to Table 3 and to delete references to the repealed Directives. Under Article 2(2) of Regulation (EU) 2017/776, the majority of those amendments were to apply from 1 June 2017, while the remaining amendments were stated to apply from 1 December 2018. However, due to an oversight, Article 2(2) failed to list two further amendments that should have applied from 1 June 2017, including in particular the amendment changing the name of the Table from ‘Table 3.1’ to ‘Table 3’. The second subparagraph of Article 2(2) of Regulation (EU) 2017/776 should therefore be corrected to include reference to those two amendments. This correction, although it has the effect of applying the two amendments retroactively, does not affect the rights and obligations of manufacturers, importers, downstream users or suppliers.

(4)

Regulation (EU) 2017/776 also amended Annex VI to Regulation (EC) No 1272/2008 to add harmonised ‘Acute Toxicity Estimate’ (ATE) values in Table 3.1 as part of the information relating to the classification and labelling of certain substances for the purposes of the classification of mixtures. The ATE introduced for nicotine was expressed in mg/kg. In order to clarify how mixtures containing nicotine should be classified, the ATE for the oral and the dermal routes for nicotine should instead be expressed in ‘mg/kg bw’ (6). The ATEs for three other substances, namely colecalciferol, 1,2-dihydroxybenzene and pinoxaden should also be expressed in the same way. In addition, in the title of the penultimate column of Table 3.1, a footnote should be added indicating what the abbreviation ‘mg/kg bw’ stands for.

(5)

The Annex to Commission Regulation (EU) 2018/669 (7) provides for the translation of the names of the substances included in Table 3.1 of Annex VI to Regulation (EC) No 1272/2008. As a consequence, the title of the second column of that Table, which currently refers to ‘international chemical identifications’, should be amended to take account of the fact that the ‘international chemical identifications’ will lose their international character once the Regulation providing for their translation in Annex VI becomes applicable. For the sake of consistency, this amendment should take effect when the translation of the names in Annex VI takes effect. The new title should reflect the terminology used in Article 18 of Regulation (EC) No 1272/2008.

(6)

Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time will be necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or revised classifications and to sell existing stocks. That period of time will also be necessary to allow suppliers to adapt to and comply with other legislative obligations resulting from the new or updated harmonised classifications, such as those set out in Article 22(f) or Article 23 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8), those set out in Article 50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (9) or those set out in Article 44 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (10).

(7)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(8)

In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow for new provisions to be applied at an earlier stage on a voluntary basis, suppliers should be allowed to apply the new and updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of those new or updated classifications.

(9)

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

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.

(3)

Commission Regulation (EU) No 231/2012 (2) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(4)

Octyl gallate (E 311) and dodecyl gallate (E 312) are substances authorised as antioxidants in a variety of foods, as well as in food flavourings, in accordance with Annexes II and III to Regulation (EC) No 1333/2008.

(5)

Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in the Union before 20 January 2009 are subject to a new risk assessment by the European Food Safety Authority (‘the Authority’).

(6)

For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) No 257/2010 (3). Pursuant to Regulation (EU) No 257/2010 the re-evaluation of antioxidants had to be completed by 31 December 2015.

(7)

On 5 May 2015 the Authority delivered a Scientific Opinion on the re-evaluation of dodecyl gallate (E 312) as a food additive (4). The opinion stated that there was a lack of adequate toxicological data on dodecyl gallate. Consequently the Authority was not able to confirm the safety of dodecyl gallate as a food additive and concluded that the present group Acceptable Daily Intake (ADI) for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) should no longer be valid. The opinion stated that a sufficient toxicological database would be required for an adequate assessment of the safety of dodecyl gallate as a food additive.

(8)

On 1 October 2015 the Authority delivered a Scientific Opinion on the re-evaluation of octyl gallate (E 311) as a food additive (5). The opinion stated that there was a lack of adequate toxicological data on octyl gallate. Consequently the Authority was not able to confirm the safety of octyl gallate as a food additive and concluded that the present group ADI for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) should no longer be valid. The opinion stated that a sufficient toxicological database would be required for an adequate assessment of the safety of octyl gallate as a food additive.

(9)

On 30 May 2017 the Commission launched a public call for scientific and technological data on propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) (6), targeting the data needs identified in the Scientific Opinions on the re-evaluation of those substances as food additives. However, no business operator committed to providing the requested toxicological data for octyl gallate (E 311) and dodecyl gallate (E 312). Without those data the Authority cannot complete the re-evaluation of the safety of octyl gallate and dodecyl gallate as food additives and consequently it cannot be determined whether those substances still fulfil the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of approved food additives.

(10)

It is therefore appropriate to remove octyl gallate (E 311) and dodecyl gallate (E 312) from the Union list of approved food additives.

(11)

Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council (7).

(12)

Article 3(1) of Regulation (EC) No 1331/2008 provides that the Union list of food additives may be updated either on the initiative of the Commission or following an application.

(13)

Therefore, Annexes II and III to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 should be amended by deleting octyl gallate (E 311) and dodecyl gallate (E 312) from the Union list of authorised food additives since due to the absence of appropriate toxicological data their inclusion in the list can no longer be justified.

(14)

It is appropriate to provide for a transitional period during which foods containing octyl gallate (E 311) and/or dodecyl gallate (E 312) that have been lawfully placed on the market before the entry in force of this Regulation may continue to be marketed.

(15)

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

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by the Member State or by an interested party.

(4)

Part A of the Union list contains both evaluated flavouring substances, for which no footnotes are assigned, and flavouring substances under evaluation, which are identified by footnote references 1 to 4.

(5)

The substances caffeine (FL No 16.016) and theobromine (FL No 16.032) were listed with footnote 1 according to which the evaluation for those substances had to be completed by the European Food Safety Authority (‘the Authority’).

(6)

On 31 January 2017, the Authority completed the evaluation of the safety of caffeine (FL No 16.016) and theobromine (FL No 16.032) when used as flavouring substances (4) and concluded that their use as flavoring substances does not give rise to safety concerns based on their estimated levels of intake in certain food categories. The conditions of use already laid down in the Union list may therefore be maintained.

(7)

Therefore, caffeine (FL No 16.016) and theobromine (FL No 16.032) should be listed as evaluated substances in the Union list of flavouring substances without the footnote reference contained in their current entries of the Union list.

(8)

Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(9)

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

(1)

Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

(2)

On 1 October 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.

(3)

Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

(1)

Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

(2)

In the light of the tenders received for the 25th partial invitation to tender, a minimum selling price should be fixed.

(3)

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

(1)

The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) entered into force on 29 January 1968. The European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN) entered into force on 29 February 2008.

(2)

The Union is not a Contracting Party to the ADR or to the ADN. All Member States are Contracting Parties to the ADR, and 13 Member States are Contracting Parties to the ADN.

(3)

Pursuant to Article 14 of the ADR, any Contracting Party can propose one or more amendments to the Annexes to the ADR. The Working Party on Transport of Dangerous Goods (WP.15) can adopt draft amendments to those Annexes. Pursuant to Article 20 of the ADN, the ADN Administrative Committee can adopt draft amendments to the Regulations annexed to the ADN. Such proposed amendments are to be deemed to have been accepted unless, within three months from the date on which the Secretary-General of the United Nations circulates them, at least one-third of the Contracting Parties, or five of them if one-third exceeds this figure, have given the Secretary-General written notification of their objection to the proposed amendments.

(4)

The proposed amendments adopted during the 2016–2018 biennium by WP.15 and the ADN Administrative Committee were circulated to the ADR and ADN Contracting Parties on 1 July 2018.

(5)

The proposed amendments are capable of decisively influencing the content of Union law, namely Directive 2008/68/EC of the European Parliament and of the Council (1). That Directive lays down requirements for the transport of dangerous goods by road, rail or inland waterways within or between Member States by referring to the ADR, to the Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) in Appendix C to the Convention concerning International Carriage by Rail (COTIF) and to the ADN. Article 4 of Directive 2008/68/EC provides that the transport of dangerous goods between Member States and third countries is to be authorised in so far as it complies with the requirements of the ADR, RID or ADN, unless otherwise indicated in the Annexes to that Directive. Under Article 8 of Directive 2008/68/EC, the Commission is empowered to adapt the Annexes to that Directive according to scientific and technical progress, in particular to take account of amendments to the ADR, the RID and the ADN.

(6)

The proposed amendments concern technical standards or uniform technical prescriptions, with the objective of ensuring the safe and efficient transport of dangerous goods whilst taking into account scientific and technical progress in the sector and the developments of new substances and articles that pose a danger during their transport. The development of the transport of dangerous goods by road and inland waterways, both within the Union and between the Union and its neighbouring countries, is a key component of the common transport policy and ensures the proper functioning of all industrial branches that produce or make use of goods classified as dangerous under the ADR and the ADN.

(7)

All the proposed amendments are justified and beneficial, and should therefore be supported by the Union. The position to be adopted on behalf of the Union as regards the proposed amendments to the Annexes to the ADR and to the Regulations annexed to the ADN should therefore be based on the attachment to this Decision,

(1)

The Association Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part (1) (‘the Agreement’) was signed by the Union in accordance with Council Decision 2014/668/EU (2) and entered into force on 1 September 2017.

(2)

Pursuant to paragraph 1 of Article 39 of Protocol I to the Agreement (‘Protocol I’), the Customs Sub-Committee established under Article 83 of Chapter 5 of Title IV of the Agreement (‘the Customs Sub-Committee’) may adopt amendments to the provisions of that Protocol.

(3)

Pursuant to paragraph 2 of Article 39 of Protocol I, the Customs Sub-Committee may also decide, following the accession of Ukraine to the Regional Convention on pan-Euro-Mediterranean preferential rules of origin (3) (‘the Convention’), to replace the rules of origin set out in that Protocol by those appended to the Convention.

(4)

The Convention lays down provisions on the origin of goods traded under relevant agreements concluded between the Contracting Parties and entered into force in relation to the Union on 1 May 2012 and in relation to Ukraine on 1 February 2018.

(5)

The Customs Sub-Committee is to adopt a Decision on the replacement of Protocol I, concerning the definition of the concept of ‘originating products’ and methods of administrative cooperation, by a new protocol which refers to the Convention.

(6)

It is appropriate to establish the position to be taken on the Union's behalf in the Customs Sub-Committee as the Decision of the Customs Sub-Committee will be binding on the Union.

(7)

Article 6 of the Convention provides that each Contracting Party is to take appropriate measures to ensure that the Convention is effectively applied. To that effect, Protocol I should be replaced by a new protocol which, with regard to the rules of origin, refers to the Convention.

(8)

The position to be taken on the Union's behalf within the Customs Sub-Committee should therefore be based on the draft Decision attached to this Decision.

(9)

As the Decision of the Customs Sub-Committee is to amend Protocol I, it should be published in the Official Journal of the European Union.

(10)

Within the Customs Sub-Committee, the Union is to be represented by the Commission in accordance with paragraph 1 of Article 17 of the Treaty on European Union,

(1)

By virtue of Council Implementing Decision 2009/1013/EU (2), the Republic of Austria (Austria) was authorised to apply a special measure derogating from Directive 2006/112/EC (‘special measure’). The application of the special measure was subsequently extended by Council Implementing Decision 2012/705/EU (3) until 31 December 2015 and by Council Implementing Decision (EU) 2015/2428 (4) until 31 December 2018.

(2)

The special measure derogates from Articles 168 and 168a of Directive 2006/112/EC which govern taxable persons' right to deduct value added tax (VAT) charged on goods and services supplied to them for the purposes of their taxed transactions. The special measure is intended to exclude VAT borne on goods and services from the right of deduction where those goods and services are used by taxable persons for more than 90 % for their private purposes or for the purposes of their employees, or in general for non-business purposes or non-economic activities.

(3)

The objective of the special measure is to simplify the procedure for charging and collecting VAT.

(4)

By letter registered with the Commission on 23 March 2018, Austria requested authorisation to continue to apply the special measure, in accordance with Article 395(2) of Directive 2006/112/EC.

(5)

By letter registered with the Commission on 4 April 2018, Austria sent a report on the application of the special measure including a review of the apportionment rate applied on the right to deduct VAT as required by Article 2 of Implementing Decision 2009/1013/EU.

(6)

The Commission transmitted the request made by Austria to the other Member States by letter dated 11 April 2018, in accordance with the second subparagraph of Article 395(2) of Directive 2006/112/EC. By letter dated 12 April 2018, the Commission notified Austria that it had all the information necessary to consider the request.

(7)

According to the information provided by Austria, the legal and factual situation which justified the current application of the special measure has not changed, but continues to exist. Austria should therefore be authorised to continue to apply the special measure for a further period of time, but that period should be limited in time until 31 December 2021 in order to allow for a review of the necessity and effectiveness of the special measure and of the apportionment rate between the business and non-business use that it is based upon.

(8)

Where Austria considers that a further extension of the authorisation beyond 2021 is necessary, a report on the application of the measure, which includes a review of the apportionment rate applied, should be submitted to the Commission together with the extension request by no later than 31 March 2021 in order to allow sufficient time for the Commission to examine the request.

(9)

The special measure will only have a negligible effect on the overall amount of tax revenue collected at the stage of final consumption and will not have adverse effects on the Union's own resources accruing from VAT.

(10)

Implementing Decision 2009/1013/EU should therefore be amended accordingly,