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Document Ares(2018)4042331

COMMISSION DELEGATED REGULATION (EU) …/... amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals

Please be aware that this draft act does not constitute the final position of the institution.

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE DELEGATED ACT

Pursuant to Article 23(1) of Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals, at least once a year the Commission is required to review, on the basis of developments in Union law and under the Convention, the list of chemicals in Annex I to that Regulation. Since the last review of Annex I a number of regulatory actions in respect of certain chemicals have been taken under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. In addition, the legal requirements under Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH), Regulation (EU) No 528/2012 on the making available of biocidal products on the market and Regulation (EU) No 2017/852 on mercury have to be taken into account. At the eighth Conference of the Parties to the Rotterdam Convention decisions were taken to include further chemicals in Annex III to the Convention. In addition, decisions were taken at the eighth Conference of the Parties to the Stockholm Convention to include further chemicals in Annex A to the Convention. Those regulatory actions and decisions should be reflected in Annexes I and V.

2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

The draft amendment was consulted with an expert group (the 'PIC DNA meeting') on 3 October 2017 and 24 April 2018 and comments were taken into account. The group is composed of all the relevant stakeholders - representatives of Member States, of the European Chemicals Agency, the chemicals industry and the civil society.

A public consultation will be carried out for the draft Commission Delegated Regulation and comments received will be considered.

3.LEGAL ELEMENTS OF THE DELEGATED ACT

The delegated act amends the lists of chemicals in Annexes I and V on the basis of developments in Union law and under the Convention, as required by Article 23(1) of Regulation (EU) No 649/2012. The legal basis for the proposed delegated act is Article 23(4) (a), (b) and (c) of Regulation (EU) No 649/2012.

COMMISSION DELEGATED REGULATION (EU) …/...

of XXX

amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals 1 , and in particular Article 23(4) thereof,

Whereas:

(1)Regulation (EU) No 649/2012 implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade ('the Rotterdam Convention') signed on 11 September 1998 and approved, on behalf of the Union, by Council Decision 2003/106/EC 2 .

(2)The Commission has adopted Implementing Regulations under Regulation (EC) No 1107/2009 of the European Parliament and of the Council 3 to not approve, or to not renew the approval of, the substances amitrole, beta-cypermethrin, DPX KE 459 (flupyrsulfuron-methyl), iprodione, linuron, orthosulfamuron, picoxystrobin and triasulfuron. In consequence, those substances are banned within the Union in the use category 'pesticides' and should therefore be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(3)The Commission has adopted an Implementing Regulation under Regulation (EC) No 1107/2009 to not renew the approval of the active substance isoproturon. In consequence, even though isoproturon has been identified and notified for evaluation under Regulation (EU) No 528/2012 of the European Parliament and of the Council 4  for product-types 7 and 10 and may therefore continue to be authorised by Member States until a decision is taken under that Regulation, the fact remains that virtually all use of it as a pesticide is prohibited. As a result, it is severely restricted within the Union in the use category 'pesticides' and should therefore be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(4)The active substance maneb was previously approved under Regulation (EC) No 1107/2009. An application was then submitted to renew that approval, but the supplementary dossier in support of renewal was not submitted. Consequently, the approval expired. As a result, maneb is banned within the Union in the use category 'pesticides' and should therefore be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(5)The active substance fipronil was previously approved under Regulation (EC) No 1107/2009. An application was then submitted to renew that approval, but the supplementary dossier in support of renewal was not submitted. Consequently, the approval expired. As a result, even though fibronil is approved under Regulation (EU) No 528/2012 for product-type 18, the fact remains that virtually all use of it as a pesticide is prohibited. Therefore, fipronil is severely restricted within the Union in the use category 'pesticides' and should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(6)At its eighth meeting held from 24 April to 5 May 2017, the Conference of the Parties to the Rotterdam Convention decided to include carbofuran, trichlorfon and short-chain chlorinated paraffins in Annex III to the Convention, with the effect that those chemicals became subject to the prior informed consent procedure under that Convention. Those changes should therefore be reflected in the lists of chemicals in Parts 1, 2 and 3 of Annex I to Regulation (EU) No 649/2012 by adding carbofuran, trichlorfon and short-chain chlorinated paraffins to the list in Part 3 and removing carbofuran and trichlorfon from the list in Part 2 and by making consequential changes to Part 1.

(7)Tributyltin compounds were included in Annex III to the Rotterdam Convention in the use category 'pesticide' following a decision taken at the fourth Conference of the Parties in 2008. At its eighth meeting held from 24 April to 5 May 2017, the Conference of the Parties decided to include tributyltin compounds in Annex III in the use category 'industrial', with the effect that tributyltin compounds became subject to the prior informed consent procedure under that Convention in the use category 'industrial' too. That change, together with changes to the regulatory status of tributyltin compounds under Regulation (EC) No 1907/2006 of the European Parliament and of the Council 5  that were made after tributyltin compounds were listed in Annex I to Regulation (EU) No 649/2012, should be reflected in the lists of chemicals in Parts 1 and 3 of Annex I to Regulation (EU) No 649/2012.

(8)At its eighth meeting held from 24 April to 5 May 2017, the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants (‘the Stockholm Convention’), which was approved by Council Decision 2006/507/EC 6 , decided to include short-chain chlorinated paraffins in Annex A to the Stockholm Convention. In order to implement the Stockholm Convention and considering that those substances are already listed in Part B of Annex I to Regulation (EC) No 850/2004 of the European Parliament and of the Council 7 , they should be added to Part 1 of Annex V to Regulation (EU) No 649/2012.

(9)Regulation (EU) 2017/852 of the European Parliament and of the Council 8 modifies the rules on the export of mixtures of metallic mercury with other substances with a mercury concentration of less than 95 %, and of certain mercury compounds. Those changes should be reflected in the existing entries in Part 2 of Annex V to Regulation (EU) No 649/2012 for mercury compounds and mixtures of metallic mercury with other substances with a mercury concentration of less than 95 %. 

(10)Regulation (EU) No 649/2012 should therefore be amended accordingly.

(11)It is appropriate to provide a reasonable period of time for interested parties to take the measures necessary to comply with this Regulation and for Member States to take the measures necessary to implement it,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 649/2012 is amended as follows:

(a)    Annex I is amended in accordance with Annex I to this Regulation;

(b)    Annex V is amended in accordance with Annex II to this Regulation.

Article 2

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

It shall apply from … [OJ: please insert the later of the following two dates: (a) 1 February 2019 or (b) the 40th calendar day after publication, if that 40th calendar day happens to fall on the 1st of a month, or if that 40th calendar day falls on any other day of the month, the 1st of the following month].

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

Done at Brussels,

   For the Commission

   The President
   […]

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ANNEX I

Annex I to Regulation (EU) No 649/2012 is amended as follows:

(1)the list of chemicals in Part 1 is amended as follows:

(a)the entry for carbofuran is replaced by the following entry:

Chemical

CAS No

Einecs No

CN code
(***)

Subcategory (*)

Use limitation (**)

Countries for which no notification is required

'Carbofuran (#)

1563-66-2

216-353-0

ex 2932 99 00

p(1)

b';

(b)the entry for tributyltin compounds is replaced by the following entry:

Chemical

CAS No

Einecs No

CN code
(***)

Subcategory (*)

Use limitation (**)

Countries for which no notification is required

'All tributyltin compounds, including:

Tributyltin oxide

Tributyltin fluoride

Tributyltin methacrylate

Tributyltin benzoate

Tributyltin chloride

Tributyltin linoleate

Tributyltin naphthenate (#)


56-35-9

1983-10-4

2155-70-6

4342-36-3

1461-22-9

24124-25-2

85409-17-2


200-268-0

217-847-9

218-452-4

224-399-8

215-958-7

246-024-7

287-083-9

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

ex 2931 20 00

p(1)-p(2)
i(1)-i(2)

b-b
sr-sr';

(c)the entry for trichlorfon is replaced by the following entry:

Chemical

CAS No

Einecs No

CN code
(***)

Subcategory (*)

Use limitation (**)

Countries for which no notification is required

'Trichlorfon (#)

52-68-6

200-149-3

ex 2931 39 90

p(1)-p(2)

b-b';

(d)the following entries are added:

Chemical

CAS No

Einecs No

CN code
(***)

Subcategory (*)

Use limitation (**)

Countries for which no notification is required

'Amitrole (+)

61-82-5

200-521-5

ex 2933 99 80

p(1)

b

Beta-cypermethrin (+)

65731-84-2

265-898-0

ex 2926 90 70

p(1)

b

DPX KE 459 (flupyrsulfuron-methyl) (+)

150315-10-9
144740-54-5

n.a.

ex 2935 90 90

p(1)

b

Fipronil (+)

120068-37-3

n.a.

ex 2933 19 90

p(1)

b

Iprodione (+)

36734-19-7

253-178-9

ex 2933 21 00

p(1)

b

Isoproturon (+)

34123-59-6

251-835-4

ex 2924 21 00

p(1)

b

Linuron (+)

330-55-2

206-356-5

ex 2928 00 90

p(1)

b

Maneb (+)

12427-38-2

235-654-8

ex 3824 99 93

p(1)-p(2)

b-b

Orthosulfamuron (+)

213464-77-8

n.a.

ex 2933 59 95

p(1)

b

Picoxystrobin (+)

117428-22-5

n.a.

ex 2933 39 99

p(1)

b

Triasulfuron (+)

82097-50-5

n.a.

ex 2935 90 90

p(1)

b';

(2)the list of chemicals in Part 2 is amended as follows:

(a)the entry for carbofuran is deleted;

(b)the entry for trichlorfon is deleted;

(c)the following entries are added:

Chemical

CAS No

Einecs No

CN code
(***)

Category (*)

Use limitation (**)

'Amitrole

61-82-5

200-521-5

ex 2933 99 80

p

b

Beta-cypermethrin

65731-84-2

265-898-0

ex 2926 90 70

p

b

DPX KE 459 (flupyrsulfuron-methyl)

150315-10-9
144740-54-5

n.a.

ex 2935 90 90

p

b

Fipronil

120068-37-3

n.a.

ex 2933 19 90

p

sr

Iprodione

36734-19-7

253-178-9

ex 2933 21 00

p

b

Isoproturon

34123-59-6

251-835-4

ex 2924 21 00

p

sr

Linuron

330-55-2

206-356-5

ex 2928 00 90

p

b

Maneb

12427-38-2

235-654-8

ex 3824 99 93

p

b

Orthosulfamuron

213464-77-8

n.a.

ex 2933 59 95

p

b

Picoxystrobin

117428-22-5

n.a.

ex 2933 39 99

p

b

Triasulfuron

82097-50-5

n.a.

ex 2935 90 90

p

b';

(3)the list of chemicals in Part 3 is amended as follows:

(a)the entry for tributyltin compounds is replaced by the following entry:

Chemical

CAS No

HS code
Pure substance

(**)

HS code
Mixtures containing substance (**)

Category

'All tributyltin compounds, including:

Tributyltin oxide

Tributyltin fluoride

Tributyltin methacrylate

Tributyltin benzoate

Tributyltin chloride

Tributyltin linoleate

Tributyltin naphthenate (#)

56-35-9

1983-10-4

2155-70-6

4342-36-3

1461-22-9

24124-25-2

85409-17-2

ex 2931.20

ex 2931.20

ex 2931.20

ex 2931.20

ex 2931.20

ex 2931.20

ex 2931.20

ex 2931.20

3808.50

3808.59

3808.92

Pesticide
Industrial
';

(b)the following entries are added:

Chemical

Relevant CAS number(s)

HS code
Pure substance

(**)

HS code
Mixtures co
ntaining substance (**)

Category

'Carbofuran

1563-66-2

ex 2932.99

3808.91

3808.59

Pesticide

Trichlorfon

52-68-6

ex 2931.39

3808.91

Pesticide

Short-chain chlorinated paraffins

85535-84-8

ex 3824.99

Industrial'.

ANNEX II

Annex V to Regulation (EU) No 649/2012 is amended as follows:

(1)    in the list in Part 1, the following entry is added:

Description of chemicals/article(s) subject to export ban

Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)

'Short-chain chlorinated paraffins

EC No 287-476-5

CAS No 85535-84-8

CN code 3824 99 92';

(2)    Part 2 is replaced by the following:

'PART 2

Chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants according to the provisions thereof.

No

Description of chemicals/article(s) subject to
export ban

Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)

1

Cosmetic soaps containing mercury

CN codes 3401 11 00, 3401 19 00, 3401 20 10,
3401 20 90, 3401 30 00

2

Metallic mercury and mixtures of metallic mercury with other substances, including alloys of mercury, with a mercury concentration of at least 95% by weight

CAS RN 7439-97-6

EC No 231-106-7

CN code 2805 40

3

The following mercury compounds except where they are exported for laboratory-scale research or laboratory analysis:

·Cinnabar ore;

·Mercury (I) chloride (Cl2Hg2);

·Mercury (II) oxide (HgO);

·Mercury sulphide (HgS).

CAS RNs 10112-91-1, 21908-53-2, 1344-48-5

EC Nos 233-307-5, 244-654-7, 215-696-3

CN codes ex 2852 10 00, ex 2852 90 00

4

All mixtures of metallic mercury with other substances, including alloys of mercury, not covered by entry 2 and all mercury compounds not covered by entry 3, if the export of that mixture or compound is for the purpose of reclaiming metallic mercury

Including:

Mercury(I) sulphate (Hg2SO4, CAS RN 7783-36-0), mercury(II) thiocyanate (Hg(SCN)2, CAS RN 592-85-8), mercury(I) iodide (Hg2I2, CAS RN 15385-57-6)

CN codes ex 2852 10 00, ex 2852 90 00'.

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