Import response for carbofuran

Country:

European Union

(Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom)

SECTION 1

IDENTITY OF CHEMICAL

1.1

Common name

Carbofuran

1.2

CAS number

1563-66-2

1.3

Category

☒

Pesticide

☐

Industrial

☐

Severely hazardous pesticide formulation

SECTION 2

INDICATION REGARDING PREVIOUS RESPONSE, IF ANY

2.1

☒

This is a first time import response for this chemical in the country.

2.2

☐

This is a modification of a previous response.

Date of issue of the previous response: …

SECTION 3

RESPONSE REGARDING FUTURE IMPORT

☒

Final decision (Fill in section 4 below) OR

☐

Interim response (Fill in section 5 below)

SECTION 4

FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES

4.1

☒

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☒ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☒ Yes

☐ No

4.2

☐

Consent to import

4.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

4.4

National legislative or administrative measure upon which the final decision is based

Description of the national legislative or administrative measure:

In the Union, it is prohibited to place on the market or use plant protection products containing carbofuran, since that active substance has not been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

Furthermore, it is prohibited to make available on the market or use biocidal products containing carbofuran, since that active substance has not been approved pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

SECTION 5

INTERIM RESPONSE

5.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

5.2

☐

Consent to import

5.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

5.4

Indication of active consideration in order to reach a final decision

Is a final decision under active consideration?

☐ Yes

☐ No

5.5

Information or assistance requested in order to reach a final decision

The following additional information is requested from the Secretariat:

The following additional information is requested from the country that notified the final regulatory action:

The following assistance is requested from the Secretariat in evaluating the chemical:

SECTION 6

RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE:

Is this chemical currently registered in the country?

☐ Yes

☒ No

Is this chemical manufactured in the country?

☐ Yes

☒ No

If yes to either one of these questions:

Is this intended for domestic use?

☐ Yes

☐ No

Is this intended for export?

☐ Yes

☐ No

Other remarks

In accordance with Regulation (EC) No 1272/2008, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, carbofuran is classified as:

Acute Toxicity 2* – H 300 — Fatal if swallowed.

Acute Toxicity 2* – H 330 — Fatal if inhaled.

Aquatic Acute 1 – H 400 — Very toxic to aquatic life.

Aquatic Chronic 1 – H410 — Very toxic to aquatic life with long lasting effects.

(* = This classification shall be considered as a minimum classification)

SECTION 7

DESIGNATED NATIONAL AUTHORITY

Institution

European Commission, DG Environment

Address

Rue de la Loi 200, 1049 Brussels, Belgium

Name of person in charge

Dr Juergen Helbig

Position of person in charge

International Chemicals Policy Coordinator

Telephone

+32 22988521

Telefax

+32 22967616

Email address

Juergen.Helbig@ec.europa.eu

Date, signature of DNA and official seal: …

PLEASE RETURN THE COMPLETED FORM TO:

Secretariat for the Rotterdam Convention

Food and Agriculture Organization

of the United Nations (FAO)

Viale delle Terme di Caracalla

00100 Rome

ITALIA

Tel. +39 0657053441

Fax +39 0657056347

Email: pic@pic.int

OR

Secretariat for the Rotterdam Convention

United Nations Environment

Programme (UNEP)

11-13, Chemin des Anémones

CH-1219 Châtelaine, Geneva

SWITZERLAND

Tel. +41 229178177

Fax +41 229178082

Email: pic@pic.int

Import response for trichlorfon

Country:

European Union

(Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom)

SECTION 1

IDENTITY OF CHEMICAL

1.1

Common name

Trichlorfon

1.2

CAS number

52-68-6

1.3

Category

☒

Pesticide

☐

Industrial

☐

Severely hazardous pesticide formulation

SECTION 2

INDICATION REGARDING PREVIOUS RESPONSE, IF ANY

2.1

☒

This is a first time import response for this chemical in the country.

2.2

☐

This is a modification of a previous response.

Date of issue of the previous response: …

SECTION 3

RESPONSE REGARDING FUTURE IMPORT

☒

Final decision (Fill in section 4 below) OR

☐

Interim response (Fill in section 5 below)

SECTION 4

FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES

4.1

☒

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☒ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☒ Yes

☐ No

4.2

☐

Consent to import

4.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

4.4

National legislative or administrative measure upon which the final decision is based

Description of the national legislative or administrative measure:

In the European Union, it is prohibited to place on the market or use plant protection products containing trichlorfon, since that active substance has not been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

Furthermore, it is prohibited to make available on the market or use biocidal products containing trichlorfon, since that active substance has not been approved pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

SECTION 5

INTERIM RESPONSE

5.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

5.2

☐

Consent to import

5.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

5.4

Indication of active consideration in order to reach a final decision

Is a final decision under active consideration?

☐ Yes

☐ No

5.5

Information or assistance requested in order to reach a final decision

The following additional information is requested from the Secretariat:

The following additional information is requested from the country that notified the final regulatory action:

The following assistance is requested from the Secretariat in evaluating the chemical:

SECTION 6

RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE:

Is this chemical currently registered in the country?

☐ Yes

☒ No

Is this chemical manufactured in the country?

☐ Yes

☒ No

If yes to either one of these questions:

Is this intended for domestic use?

☐ Yes

☐ No

Is this intended for export?

☐ Yes

☐ No

Other remarks

In accordance with Regulation (EC) No 1272/2008, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, trichlorfon is classified as:

Acute Toxicity 4* – H 302 — Harmful if swallowed.

Skin Sensitisation 1 – H 317 — May cause an allergic skin reaction.

Aquatic Acute 1 – H 400 — Very toxic to aquatic life.

Aquatic Chronic 1 – H 410 — Very toxic to aquatic life with long lasting effects.

(* = This classification shall be considered as a minimum classification)

SECTION 7

DESIGNATED NATIONAL AUTHORITY

Institution

European Commission, DG Environment

Address

Rue de la Loi 200, 1049 Brussels, Belgium

Name of person in charge

Dr Juergen Helbig

Position of person in charge

International Chemicals Policy Coordinator

Telephone

+32 22988521

Telefax

+32 22967616

Email address

Juergen.Helbig@ec.europa.eu

Date, signature of DNA and official seal: …

PLEASE RETURN THE COMPLETED FORM TO:

Secretariat for the Rotterdam Convention

Food and Agriculture Organization

of the United Nations (FAO)

Viale delle Terme di Caracalla

00100 Rome

ITALIA

Tel. +39 0657053441

Fax +39 0657056347

Email: pic@pic.int

OR

Secretariat for the Rotterdam Convention

United Nations Environment

Programme (UNEP)

11-13, Chemin des Anémones

CH-1219 Châtelaine, Geneva

SWITZERLAND

Tel. +41 229178177

Fax +41 229178082

Email: pic@pic.int

Import response for short-chain chlorinated paraffins

Country:

European Union

(Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom)

SECTION 1

IDENTITY OF CHEMICAL

1.1

Common name

Short-chain chlorinated paraffins

1.2

CAS number

85535-84-8

1.3

Category

☐

Pesticide

☒

Industrial

☐

Severely hazardous pesticide formulation

SECTION 2

INDICATION REGARDING PREVIOUS RESPONSE, IF ANY

2.1

☒

This is a first time import response for this chemical in the country.

2.2

☐

This is a modification of a previous response.

Date of issue of the previous response: …

SECTION 3

RESPONSE REGARDING FUTURE IMPORT

☒

Final decision (Fill in section 4 below) OR

☐

Interim response (Fill in section 5 below)

SECTION 4

FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES

4.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

4.2

☐

Consent to import

4.3

☒

Consent to import only subject to specified conditions

The specified conditions are:

In the European Union, the production, placing on the market and use of short-chain chlorinated paraffins (SCCPs), whether on their own, in preparations or as constituents of articles, are prohibited pursuant to Regulation (EC) No 850/2004. This prohibition also includes the import of short-chain chlorinated paraffins (SCCPs).

By way of derogation, the placing on the market and use (including the import) of substances or preparations containing SCCPs in concentrations lower than 1 % by weight is allowed.

Are the conditions for import of the chemical the same for all sources of import?

☒ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☒ Yes

☐ No

4.4

National legislative or administrative measure upon which the final decision is based

Description of the national legislative or administrative measure:

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7) stipulates that the production, placing on the market and use of short-chain chlorinated paraffins (SCCPs), whether on their own, in preparations or as constituents of articles, are prohibited.

By way of derogation, the production, placing on the market and use of substances or preparations containing SCCPs in concentrations lower than 1 % by weight or articles containing SCCPs in concentrations lower than 0,15 % by weight are allowed.

SECTION 5

INTERIM RESPONSE

5.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

5.2

☐

Consent to import

5.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

5.4

Indication of active consideration in order to reach a final decision

Is a final decision under active consideration?

☐ Yes

☐ No

5.5

Information or assistance requested in order to reach a final decision

The following additional information is requested from the Secretariat:

The following additional information is requested from the country that notified the final regulatory action:

The following assistance is requested from the Secretariat in evaluating the chemical:

SECTION 6

RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE:

Is this chemical currently registered in the country?

☐ Yes

☒ No

Is this chemical manufactured in the country?

☐ Yes

☒ No

If yes to either one of these questions:

Is this intended for domestic use?

☐ Yes

☐ No

Is this intended for export?

☐ Yes

☐ No

Other remarks

In accordance with Regulation (EC) No 1272/2008, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, short-chain chlorinated paraffins are classified as:

Carc. 2 – H 351 — Suspected of causing cancer.

Aquatic Acute 1 – H 400 — Very toxic to aquatic life.

Aquatic Chronic 1 – H 410 — Very toxic to aquatic life with long lasting effects.

SECTION 7

DESIGNATED NATIONAL AUTHORITY

Institution

European Commission, DG Environment

Address

Rue de la Loi 200, 1049 Brussels, Belgium

Name of person in charge

Dr Juergen Helbig

Position of person in charge

International Chemicals Policy Coordinator

Telephone

+32 22988521

Telefax

+32 22967616

Email address

Juergen.Helbig@ec.europa.eu

Date, signature of DNA and official seal: …

PLEASE RETURN THE COMPLETED FORM TO:

Secretariat for the Rotterdam Convention

Food and Agriculture Organization

of the United Nations (FAO)

Viale delle Terme di Caracalla

00100 Rome

ITALIA

Tel. +39 0657053441

Fax +39 0657056347

Email: pic@pic.int

OR

Secretariat for the Rotterdam Convention

United Nations Environment

Programme (UNEP)

11-13, Chemin des Anémones

CH-1219 Châtelaine, Geneva

SWITZERLAND

Tel. +41 229178177

Fax +41 229178082

Email: pic@pic.int

Import response for tributyltin compounds

Country:

European Union

(Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom)

SECTION 1

IDENTITY OF CHEMICAL

1.1

Common name

Tributyltin compounds, i.e. all tributyltin compounds including

Tributyltin oxide

Tributyltin fluoride

Tributyltin methacrylate

Tributyltin benzoate

Tributyltin chloride

Tributyltin linoleate

Tributyltin naphthenate

1.2

CAS number

56-35-9 — Tributyltin oxide

1983-10-4 — Tributyltin fluoride

2155-70-6 — Tributyltin methacrylate

4342-36-3 — Tributyltin benzoate

1461-22-9 — Tributyltin chloride

24124-25-2 — Tributyltin linoleate

85409-17-2 — Tributyltin naphthenate

1.3

Category

☐

Pesticide

☒

Industrial

☐

Severely hazardous pesticide formulation

SECTION 2

INDICATION REGARDING PREVIOUS RESPONSE, IF ANY

2.1

☒

This is a first time import response for this chemical in the country.

2.2

☐

This is a modification of a previous response.

Date of issue of the previous response: …

SECTION 3

RESPONSE REGARDING FUTURE IMPORT

☒

Final decision (Fill in section 4 below) OR

☐

Interim response (Fill in section 5 below)

SECTION 4

FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES

4.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

4.2

☐

Consent to import

4.3

☒

Consent to import only subject to specified conditions

The specified conditions are:

In the European Union, the placing on the market and use (including import) of tributyltin compounds as industrial chemicals are allowed, subject to compliance with the conditions set out in Regulation (EC) No 1907/2006, in particular the restriction with regard to organostannic compounds laid down in Annex XVII to that Regulation, which stipulates that organostannic compounds:

1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint.

2. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide to prevent the fouling by micro-organisms, plants or animals of:

(a) all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes;

(b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming;

(c) any totally or partly submerged appliance or equipment.

3. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters.

Are the conditions for import of the chemical the same for all sources of import?

☒ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☒ Yes

☐ No

4.4

National legislative or administrative measure upon which the final decision is based

Description of the national legislative or administrative measure:

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 (OJ L 396, 30.12.2006, p. 1), in particular the restriction with regard to organostannic compounds laid down in Annex XVII to that Regulation stipulates that the placing on the market and use (including import) of tributyltin compounds as industrial chemicals are allowed, subject to compliance with certain conditions.

SECTION 5

INTERIM RESPONSE

5.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

5.2

☐

Consent to import

5.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☐ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☐ Yes

☐ No

5.4

Indication of active consideration in order to reach a final decision

Is a final decision under active consideration?

☐ Yes

☐ No

5.5

Information or assistance requested in order to reach a final decision

The following additional information is requested from the Secretariat:

The following additional information is requested from the country that notified the final regulatory action:

The following assistance is requested from the Secretariat in evaluating the chemical:

SECTION 6

RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE:

Is this chemical currently registered in the country?

☒ Yes

☐ No

Is this chemical manufactured in the country?

☒ Yes

☐ No

If yes to either one of these questions:

Is this intended for domestic use?

☒ Yes

☐ No

Is this intended for export?

☒ Yes

☐ No

Other remarks

In accordance with Regulation (EC) No 1272/2008, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, tributyltin compounds are classified as follows (It should be noted that the below classification applies to all tributyltin compounds with the exception of those individual compounds that have a different classification):

Acute Tox. 3 – H 301 (Toxic if swallowed.)

Acute Tox. 4* – H 312 (Harmful in contact with skin.)

Skin Irrit. 2 – H 315 (Causes skin irritation.)

Eye Irrit. 2 – H 319 (Causes serious eye irritation.)

STOT RE 1 – H 372 ** (Causes damage to organs through prolonged or repeated exposure.)

Aquatic Acute 1 – H 400 (Very toxic to aquatic life.)

Aquatic Chronic 1 – H 410 (Very toxic to aquatic life with long lasting effect.)

Repr. 1B – H360FD (May damage fertility. May damage the unborn child.)

(* = This classification shall be considered as a minimum classification.)

(** = Information on the route of exposure is not available.)

SECTION 7

DESIGNATED NATIONAL AUTHORITY

Institution

European Commission, DG Environment

Address

Rue de la Loi 200, 1049 Brussels, Belgium

Name of person in charge

Dr Juergen Helbig

Position of person in charge

International Chemicals Policy Coordinator

Telephone

+32 22988521

Telefax

+32 22967616

Email address

Juergen.Helbig@ec.europa.eu

Date, signature of DNA and official seal: …

PLEASE RETURN THE COMPLETED FORM TO:

Secretariat for the Rotterdam Convention

Food and Agriculture Organization

of the United Nations (FAO)

Viale delle Terme di Caracalla

00100 Rome

ITALIA

Tel. +39 0657053441

Fax +39 0657056347

Email: pic@pic.int

OR

Secretariat for the Rotterdam Convention

United Nations Environment

Programme (UNEP)

11-13, Chemin des Anémones

CH-1219 Châtelaine, Geneva

SWITZERLAND

Tel. +41 229178177

Fax +41 229178082

Email: pic@pic.int

Import response for ethylene oxide

Country:

European Union

(Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom)

SECTION 1

IDENTITY OF CHEMICAL

1.1

Common name

Ethylene oxide

1.2

CAS number

75-21-8

1.3

Category

☒

Pesticide

☐

Industrial

☐

Severely hazardous pesticide formulation

SECTION 2

INDICATION REGARDING PREVIOUS RESPONSE, IF ANY

2.1

☐

This is a first time import response for this chemical in the country.

2.2

☒

This is a modification of a previous response.

Date of issue of the previous response: 03/2017 …

SECTION 3

RESPONSE REGARDING FUTURE IMPORT

☒

Final decision (Fill in section 4 below) OR

☐

Interim response (Fill in section 5 below)

SECTION 4

FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES

4.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

4.2

☐

Consent to import

4.3

☒

Consent to import only subject to specified conditions

The specified conditions are:

For plant protection products

In the European Union, it is prohibited to place on the market (including import) or use plant protection products containing ethylene oxide, since that active substance has not been approved under Regulation (EC) No 1107/2009.

For biocidal products

Ethylene oxide is under review in accordance with Regulation (EU) No 528/2012 for uses covered by product type 2 and therefore the making available on the market and use of biocidal products containing ethylene oxide is only allowed for uses covered by product-type 2, which are disinfectants and algaecides not intended for direct application to humans or animals as defined in Annex V to that Regulation.

Responses of individual Member States of the European Union for ethylene oxide in biocidal products falling within product-type 2 are as follows:

Member States that consent to import, subject to any national restrictions that may apply: Belgium, Denmark, France, Germany, Estonia, Ireland, Latvia, Luxembourg, Sweden, UK.

Member States that consent to import, subject to prior written authorisation: Austria, Bulgaria, Croatia, Finland, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Slovenia.

Member States that consent to import only for sterilisation of surgical tools in accordance with Council Directive 93/42/EC concerning medical devices (OJ L 169, 12.7.1993, p. 1), subject to prior written authorisation: Cyprus, Greece, Slovakia, Spain, Romania.

Member States that do not consent to import: Czech Republic, Malta.

Are the conditions for import of the chemical the same for all sources of import?

☒ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☒ Yes

☐ No

4.4

National legislative or administrative measure upon which the final decision is based

Description of the national legislative or administrative measure:

Plant protection products

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1) prohibits to place on the market or use plant protection products containing ethylene oxide.

Biocidal products

Ethylene oxide has not been approved as an active substance under Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). It is, however, under review and listed in Annex II to Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). Consequently, in the European Union, the making available on the market and use of biocidal products containing ethylene oxide is only allowed for uses covered by product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals) as defined in Annex V to Regulation (EU) No 528/2012.

SECTION 5

INTERIM RESPONSE

5.1

☐

No consent to import

Is the import of the chemical from all sources simultaneously prohibited?

☐ Yes

☐ No

Is domestic production of the chemical for domestic use simultaneously prohibited?

☐ Yes

☐ No

5.2

☐

Consent to import

5.3

☐

Consent to import only subject to specified conditions

The specified conditions are:

Are the conditions for import of the chemical the same for all sources of import?

☒ Yes

☐ No

Are the conditions for domestic production of the chemical for domestic use the same as for all imports?

☒ Yes

☐ No

5.4

Indication of active consideration in order to reach a final decision

Is a final decision under active consideration?

☒ Yes

☐ No

5.5

Information or assistance requested in order to reach a final decision

The following additional information is requested from the Secretariat:

The following additional information is requested from the country that notified the final regulatory action:

The following assistance is requested from the Secretariat in evaluating the chemical:

SECTION 6

RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE:

Is this chemical currently registered in the country?

☒ Yes

☐ No

Is this chemical manufactured in the country?

☒ Yes

☐ No

If yes to either one of these questions:

Is this intended for domestic use?

☒ Yes

☐ No

Is this intended for export?

☒ Yes

☐ No

Other remarks

In accordance with Regulation (EC) No 1272/2008, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, ethylene oxide is classified as:

Press. Gas

Flam. Gas 1 – H 220 – Extremely flammable gas.

Skin Irrit. 2 – H 315 – Causes skin irritation.

Eye Irrit. 2 – H 319 – Causes serious eye irritation.

Acute Tox. 3* – H 331 – Toxic if inhaled.

STOT SE 3 – H 335 – May cause respiratory irritation.

Muta. 1B – H 340 – May cause genetic defects.

Carc. 1B – H 350 – May cause cancer.

(* = This classification shall be considered as a minimum classification)

SECTION 7

DESIGNATED NATIONAL AUTHORITY

Institution

European Commission, DG Environment

Address

Rue de la Loi 200, 1049 Brussels, Belgium

Name of person in charge

Dr Juergen Helbig

Position of person in charge

International Chemicals Policy Coordinator

Telephone

+32 22988521

Telefax

+32 22967616

Email address

Juergen.Helbig@ec.europa.eu

Date, signature of DNA and official seal: …

PLEASE RETURN THE COMPLETED FORM TO:

Secretariat for the Rotterdam Convention

Food and Agriculture Organization

of the United Nations (FAO)

Viale delle Terme di Caracalla

00100 Rome

ITALIA

Tel. +39 0657053441

Fax +39 0657056347

Email: pic@pic.int

OR

Secretariat for the Rotterdam Convention

United Nations Environment

Programme (UNEP)

11-13, Chemin des Anémones

CH-1219 Châtelaine, Geneva

SWITZERLAND

Tel. +41 229178177

Fax +41 229178082

Email: pic@pic.int