ISSN 1725-2555

Official Journal

of the European Union

L 6

European flag  

English edition

Legislation

Volume 52
10 January 2009


Contents

 

I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

page

 

 

REGULATIONS

 

*

Council Regulation (EC) No 15/2009 of 8 January 2009 amending Regulation (EC) No 367/2006 imposing a definitive countervailing duty on imports of polyethylene terephthalate (PET) film originating in India and amending Regulation (EC) No 1292/2007 imposing a definitive anti-dumping duty on imports of polyethylene terephthalate (PET) film originating in India

1

 

 

Commission Regulation (EC) No 16/2009 of 9 January 2009 establishing the standard import values for determining the entry price of certain fruit and vegetables

18

 

 

DIRECTIVES

 

*

Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) ( 1 )

20

 

 

II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

 

 

DECISIONS

 

 

Commission

 

 

2009/10/EC

 

*

Commission Decision of 2 December 2008 establishing a major accident report form pursuant to Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (notified under document number C(2008) 7530)  ( 1 )

64

 

 

2009/11/EC

 

*

Commission Decision of 19 December 2008 authorising methods for grading pig carcases in Spain (notified under document number C(2008) 8477)

79

 

 

2009/12/EC

 

*

Commission Decision of 19 December 2008 authorising methods for grading pig carcases in Denmark (notified under document number C(2008) 8498)

83

 

 

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

 

 

2009/13/EC

 

*

Decision No 1/2008 of the Joint Veterinary Committee set up by the Agreement between the European Community and the Swiss Confederation on trade in agricultural products of 23 December 2008 regarding the amendment of Appendices 2, 3, 4, 5, 6 and 10 to Annex 11 to the Agreement

89

 

 

Corrigenda

 

*

Corrigendum to Commission Regulation (EC) No 1077/2008 of 3 November 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 1966/2006 on electronic recording and reporting of fishing activities and on means of remote sensing and repealing Regulation (EC) No 1566/2007 (OJ L 295, 4.11.2008)

117

 

 

 

*

Note to the reader (see page 3 of the cover)

s3

 


 

(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.


I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

REGULATIONS

10.1.2009   

EN

Official Journal of the European Union

L 6/1


COUNCIL REGULATION (EC) No 15/2009

of 8 January 2009

amending Regulation (EC) No 367/2006 imposing a definitive countervailing duty on imports of polyethylene terephthalate (PET) film originating in India and amending Regulation (EC) No 1292/2007 imposing a definitive anti-dumping duty on imports of polyethylene terephthalate (PET) film originating in India

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 2026/97 of 6 October 1997 on protection against subsidised imports from countries not members of the European Community (1) (the basic Regulation), and in particular Articles 19 and 24 thereof,

Having regard to the proposal submitted by the Commission after consulting the Advisory Committee,

Whereas:

A.   PROCEDURE

I.   Previous investigation and existing countervailing measures

(1)

In December 1999, by Regulation (EC) No 2597/1999 (2), the Council imposed a definitive countervailing duty on imports of polyethylene terephthalate (PET) film (the product concerned) falling within CN codes ex 3920 62 19 and ex 3920 62 90, originating in India. The investigation which led to the adoption of that Regulation is hereinafter referred to as the ‘original investigation’. The measures took the form of an ad valorem countervailing duty, ranging between 3,8 % and 19,1 % imposed on imports from individually named exporters, with a residual duty rate of 19,1 % imposed on imports of the product concerned from all other companies. The investigation period of the original investigation was 1 October 1997 to 30 September 1998.

(2)

In March 2006, by Regulation (EC) No 367/2006 (3), the Council, following an expiry review pursuant to Article 18 of the basic Regulation, maintained the definitive countervailing duty imposed by Regulation (EC) No 2597/1999 on imports of PET film originating in India. The review investigation period was 1 October 2003 to 30 September 2004.

(3)

In August 2006, by Regulation (EC) No 1288/2006 (4), the Council, following an interim review concerning the subsidisation of an Indian PET film producer, Garware Polyester Limited (Garware), amended the definitive countervailing duty imposed on Garware by Regulation (EC) No 367/2006.

(4)

In September 2007, by Regulation (EC) No 1124/2007 (5), the Council, following a partial interim review concerning the subsidisation of another Indian PET film producer, Jindal Poly Films, Limited, formerly known as Jindal Polyester Ltd, (Jindal), amended the definitive countervailing duty imposed on Jindal by Regulation (EC) No 367/2006.

II.   Existing anti-dumping measures

(5)

In August 2001, by Regulation (EC) No 1676/2001 (6), the Council imposed a definitive anti-dumping duty on imports of polyethylene terephthalate (PET) film originating, inter alia, in India. The measures consisted of an ad valorem anti-dumping duty ranging between 0 % and 62,6 % imposed on imports from individually named exporters, with a residual duty rate of 53,3 % on imports from all other companies.

(6)

In March 2006, by Regulation (EC) No 366/2006 (7), the Council amended the level of dumping margins calculated by Regulation (EC) No 1676/2001. The new dumping margins range between 3,2 % and 29,3 % and the new dumping duty range between 0 % and 18 % taking into account the countervailing duties resulting from export subsidies imposed on the same products originating in India, as modified according to Regulation (EC) No 367/2006, which was adopted following an expiry review of Regulation (EC) No 2579/1999 referred to in recital 1 above. In August 2006, by Regulation (EC) No 1288/2006, the Council, following an interim review concerning the subsidisation of an Indian PET film producer, Garware Polyester Limited (Garware), amended the definitive anti-dumping duty imposed on Garware by Regulation (EC) No 1676/2001.

(7)

In September 2006, by Regulation (EC) No 1424/2006 (8), the Council, following a new exporting producer request amended Regulation (EC) No 1676/2001 in respect of SRF Limited. The Regulation established a dumping margin of 15,5 % and a dumping duty rate of 3,5 % for the company concerned taking into account the company’s export subsidy margin as ascertained in the anti-subsidy investigation which led to the adoption of Regulation (EC) No 367/2006 referred to above. Since the company did not have an individual countervailing duty, the rate established for all other companies was applied.

(8)

The Council, by Regulation (EC) No 1292/2007 (9) imposed a definitive anti-dumping duty on imports of polyethylene terephthalate (PET) film originating in India following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from countries not members of the European Community (10) (the basic anti-dumping Regulation). The same Regulation terminated a partial interim review of such imports limited to one India exporter pursuant to Article 11(3) of the basic anti-dumping Regulation.

III.   Initiation of a partial interim review

(9)

Following the extension of the validity of the definitive countervailing duty in March 2006, the Government of India (GOI) made submissions that the circumstances with regard to two subsidy schemes (the Duty Entitlement Passbook Scheme and the Income Tax Exemption under Section 80 HHC of the Income Tax Act) had changed and that these changes were of a lasting nature. Consequently, it was argued that the level of subsidisation was likely to have decreased and thus measures that had been established partly on these schemes should be revised.

(10)

The Commission examined the evidence submitted by the GOI and considered it sufficient to justify the initiation of a review in accordance with the provisions of Article 19 of the basic Regulation. After consultation of the Advisory Committee, the Commission initiated, by a Notice of Initiation published in the Official Journal of the European Union on 12 October 2007 (11), an ex officio partial interim review limited to the level of subsidisation of the countervailing duty in force in respect of imports of polyethylene terephthalate (PET) film originating in India.

(11)

The purpose of the partial interim review investigation is to assess the need for the continuation, removal or amendment of the existing measures in respect of those companies which benefited from one or both subsidy schemes that had allegedly changed, where sufficient evidence was provided in line with the relevant provisions of the Notice of Initiation. The partial interim review investigation would also assess the need, depending on the review findings, to revise the measures applicable to other companies that cooperated in the investigation that set the level of the existing measures and/or the residual measure applicable for all other companies.

(12)

The review was limited to the level of subsidisation of the companies listed in the Annex to the Notice of Initiation as well as to other exporters that were invited to make themselves known under the conditions and within the time limit set out in the Notice of Initiation.

IV.   Investigation period

(13)

The investigation of the level of subsidisation covered the period from 1 October 2006 to 30 September 2007 (‘review investigation period’ or ‘RIP’).

V.   Parties concerned by the investigation

(14)

The Commission officially informed the GOI and those Indian exporting producers who cooperated in the previous investigation, were mentioned under Regulation (EC) No 367/2006 and were listed in the Annex to the Notice of Initiation of the partial interim review, that were found to benefit from any of the two allegedly changed subsidy schemes, as well as Du Pont Tejin Films, Luxembourg, Mitsubishi Polyester Film, Germany, Toray Plastics Europe, France and Nurell, Italy, which represent the overwhelming majority of Community PET film production (hereinafter the Community industry), of the initiation of the partial interim review investigation. Interested parties were given the opportunity to make their views known in writing and to request a hearing within the time limit set out in the Notice of Initiation.

(15)

All interested parties, who so requested and showed that there were particular reasons why they should be heard, were granted a hearing.

(16)

The written and oral comments submitted by the parties were considered and, where appropriate, taken into account.

(17)

In view of the apparent number of parties involved in this review, the use of sampling techniques for the investigation of subsidisation was envisaged in accordance with Article 27 of the basic Regulation. In order to enable the Commission to decide whether sampling would be necessary and, if so, to select a sample, exporting producers were requested, pursuant to Article 27 of the basic Regulation, to make themselves known within 15 days of the initiation of the partial interim review and to provide the Commission with the information requested in the Notice of Initiation.

(18)

After examination of the information submitted, given the number of exporting producers in India indicating their willingness to cooperate, it was decided that sampling was not necessary in this case.

(19)

One company, SRF Limited, not listed in the Annex to the Notice of Initiation, made itself known and provided evidence that it fulfilled the eligibility provisions of the scope of the partial interim review investigation as those set out in point 4 of the Notice of Initiation. Consequently this company was included in this review investigation.

(20)

One company, Flex Industries Limited, subject to a countervailing duty (Regulation (EC) No 367/2006) and an anti-dumping duty (Regulation (EC) No 1292/2007) has changed its name and is now known as Uflex Limited. This change of name does not affect the findings of previous investigations.

(21)

In order to obtain the information necessary for its investigation, the Commission sent questionnaires to the exporting producers which fulfilled the conditions set out in the Notice of Initiation. In addition, a questionnaire was sent to the GOI.

(22)

Replies from the questionnaires were received from five Indian exporting producers, and from the GOI.

(23)

The Commission sought and verified all information it deemed necessary for the determination of subsidisation. Verification visits were carried out at the premises of GOI in Delhi, the Government of Maharashtra in Mumbai, the Reserve Bank of India in Mumbai, and the following companies:

Ester Industries Limited, New Delhi,

Garware Polyester Limited, Mumbai,

Polyplex Corporation Limited, Noida,

SRF Limited, Gurgaon,

Uflex Limited, Noida.

VI.   Disclosure and comments on procedure

(24)

The GOI and the other interested parties were informed of the essential facts and considerations upon which it was intended to propose to amend the duty rates applicable to the concerned cooperating Indian exporting producers and prolong existing measures for all other companies which did not cooperate with this partial interim review. They were also given a reasonable time to comment. All submissions and comments were taken duly into consideration as set out below.

B.   PRODUCT CONCERNED

(25)

The product covered by this review is the same product as the one concerned by Regulation (EC) No 367/2006, namely polyethylene terephthalate (PET) film falling within CN codes ex 3920 62 19 and ex 3920 62 90 originating in India.

C.   SUBSIDISATION

1.   Introduction

(26)

On the basis of the information submitted by the GOI and the cooperating Indian exporting producers and the replies to the Commission’s questionnaire, the following schemes, which allegedly involve the granting of subsidies, were investigated:

(a)

Advance Authorisation Scheme (formerly known as Advance Licence Scheme);

(b)

Duty Entitlement Passbook Scheme;

(c)

Export Promotion Capital Goods Scheme;

(d)

Special Economic Zones/Export Processing Zones/Export Oriented Units;

(e)

Income Tax Exemption Scheme;

(f)

Export Credit Scheme;

(g)

Package Scheme of Incentives (PSI).

(27)

The schemes (a) to (d) specified above are based on the Foreign Trade (Development and Regulation) Act 1992 (No 22 of 1992) which entered into force on 7 August 1992 (Foreign Trade Act). The Foreign Trade Act authorises the GOI to issue notifications regarding the export and import policy. These are summarised in ‘Export and Import Policy’ documents, which are issued by the Ministry of Commerce every five years and updated regularly. One Export and Import Policy document is relevant to the RIP of this case, i.e. the five-year plan relating to the period 1 September 2004 to 31 March 2009 (EXIM-policy 04-09). In addition, the GOI also sets out the procedures governing the EXIM-policy 04-09 in a ‘Handbook of Procedures — 1 September 2004 to 31 March 2009, Volume I’ (HOP I 04-09). The Handbook of Procedure is also updated on a regular basis.

(28)

The Income Tax Scheme specified above under (e) is based on the Income Tax Act of 1961, which is amended yearly by the Finance Act.

(29)

The Export Credit Scheme specified above under (f) is based on sections 21 and 35A of the Banking Regulation Act 1949, which allow the Reserve Bank of India (RBI) to direct commercial banks in the field of export credits.

(30)

The scheme specified above under (g) is managed by State authorities in India.

(31)

In accordance with Article 11(10) of the basic Regulation, the Commission invited the GOI for additional consultations with respect to both changed and unchanged schemes with the aim of clarifying the factual situation as regards the alleged schemes and arriving at a mutually agreed solution. Following these consultations, and in the absence of a mutually agreed solution in relation to these schemes, the Commission included all these schemes in the investigation of subsidisation.

(32)

Following disclosure, the GOI and one exporting producer argued that it has not been determined that the schemes investigated confer a benefit to the recipient. In addressing this claim, it should be noted that for each scheme under investigation, it was established whether any concession is a subsidy within the meaning of Article 2(1)(a) and Article 2(2) of the basic Regulation, i.e. a financial contribution of the GOI which conferred a benefit upon the investigated exporting producers. Moreover, it has been explained why benefits under the various schemes are considered countervailable. In addition, all cooperating exporting producers have received a detailed calculation sheet explaining how the benefits were established under each scheme. Consequently, this claim has to be rejected.

2.   Advance Authorisation Scheme (AAS)

(a)   Legal basis

(33)

The detailed description of the scheme is contained in paragraphs 4.1.1 to 4.1.14 of the EXIM-policy 04-09 and chapters 4.1 to 4.30 of the HOP I 04-09. This scheme was called Advance Licence Scheme during the previous review investigation that led to the imposition by Regulation (EC) No 367/2006 of the definitive countervailing duty currently in force.

(b)   Eligibility

(34)

The AAS consists of six sub-schemes, as described in more detail in recital 35. Those sub-schemes differ, inter alia, in the scope of eligibility. Manufacturer-exporters and merchant-exporters ‘tied to’ supporting manufacturers are eligible for the AAS physical exports and for the AAS for annual requirement. Manufacturer-exporters supplying the ultimate exporter are eligible for AAS for intermediate supplies. Main contractors which supply to the ‘deemed export’ categories mentioned in paragraph 8.2 of the EXIM-policy 04-09, such as suppliers of an export oriented unit (EOU), are eligible for AAS deemed export. Eventually, intermediate suppliers to manufacturer-exporters are eligible for ‘deemed export’ benefits under the sub-schemes Advance Release Order (ARO) and back-to-back inland letter of credit.

(c)   Practical implementation

(35)

Advance authorisations can be issued for:

(i)

Physical exports: This is the main sub-scheme. It allows for duty-free import of input materials for the production of a specific resulting export product. ‘Physical’ in this context means that the export product has to leave Indian territory. An import allowance and export obligation including the type of export product are specified in the licence;

(ii)

Annual requirement: Such an authorisation is not linked to a specific export product, but to a wider product group (e.g. chemical and allied products). The licence holder can — up to a certain value threshold set by its past export performance — import duty free any input to be used in manufacturing any of the items falling under such a product group. It can choose to export any resulting product falling under the product group using such duty-exempt material;

(iii)

Intermediate supplies: This sub-scheme covers cases where two manufacturers intend to produce a single export product and divide the production process. The manufacturer-exporter who produces the intermediate product can import duty-free input materials and can obtain for this purpose an AAS for intermediate supplies. The ultimate exporter finalises the production and is obliged to export the finished product;

(iv)

Deemed exports: This sub-scheme allows a main contractor to import inputs free of duty which are required in manufacturing goods to be sold as ‘deemed exports’ to the categories of customers mentioned in paragraph 8.2.(b) to (f),(g),(i) and (j) of the EXIM policy 04-09. According to the GOI, deemed exports refer to those transactions in which the goods supplied do not leave the country. A number of categories of supply is regarded as deemed exports provided the goods are manufactured in India, e.g. supply of goods to an EOU or to a company situated in a special economic zone (SEZ);

(v)

ARO: The AAS holder intending to source the inputs from indigenous sources, in lieu of direct import, has the option to source them against AROs. In such cases the Advance Authorisations are validated as AROs and are endorsed to the indigenous supplier upon delivery of the items specified therein. The endorsement of the ARO entitles the indigenous supplier to the benefits of deemed exports as set out in paragraph 8.3 of the EXIM-policy 04-09 (i.e. AAS for intermediate supplies/deemed export, deemed export drawback and refund of terminal excise duty). The ARO mechanism refunds taxes and duties to the supplier instead of refunding the same to the ultimate exporter in the form of drawback/refund of duties. The refund of taxes/duties is available both for indigenous inputs as well as imported inputs;

(vi)

Back-to-back inland letter of credit: This sub-scheme again covers indigenous supplies to an Advance Authorisation holder. The holder of an Advance Authorisation can approach a bank for opening an inland letter of credit in favour of an indigenous supplier. The authorisation will be invalidated by the bank for direct import only in respect of the value and volume of items being sourced indigenously instead of importation. The indigenous supplier will be entitled to deemed export benefits as set out in paragraph 8.3 of the EXIM-policy 04-09 (i.e. AAS for intermediate supplies/deemed export, deemed export drawback and refund of terminal excise duty).

(36)

Three of the cooperating exporting producers received concessions under the AAS linked to the product concerned during the RIP. Two of these companies made use two of the sub-schemes, i.e. (i) AAS physical exports and (iii) AAS for intermediate supplies. The third company used sub-scheme (ii) AAS for annual requirement. It is therefore not necessary to establish the countervailability of the remaining unused sub-schemes.

(37)

For verification purposes by the Indian authorities, an Advance Authorisation holder is legally obliged to maintain ‘a true and proper account of consumption and utilisation of duty-free imported/domestically procured goods’ in a specified format (chapters 4.26, 4.30 and Appendix 23 HOP I 04-09), i.e. an actual consumption register. This register has to be verified by an external chartered accountant/cost and works accountant who issues a certificate stating that the prescribed registers and relevant records have been examined and the information furnished under Appendix 23 is true and correct in all respects. Nevertheless, the aforesaid provisions apply only to Advance Authorisations issued on or after 13 May 2005. For all Advance Authorisations or Advance Licences issued before that date, holders are requested to follow the previously applicable verification provisions, i.e. to keep a true and proper account of licence-wise consumption and utilisation of imported goods in the specified format of Appendix 18 (chapter 4.30 and Appendix 18 HOP I 02-07).

(38)

With regard to the sub-schemes used during the RIP by two cooperating exporting producers, i.e. physical exports and intermediate supplies, both the import allowance and the export obligation are fixed in volume and value by the GOI and are documented on the authorisation. In addition, at the time of import and of export, the corresponding transactions are to be documented by government officials on the authorisation. The volume of imports allowed under the AAS is determined by the GOI on the basis of standard input-output norms (SIONs). SIONs exist for most products including the product concerned and are published in the HOP II 04-09. The most recent changes in the SIONs for PET film and PET chips, an intermediate product, were revised in September 2005.

(39)

With regard to sub-scheme (ii) listed above (AAS for annual requirement) that was used by the other exporter, only the import allowance in value is documented on the licence. The licence holder is obliged to ‘maintain the nexus between inputs and the resultant product’ (paragraph 4.24A(c) HOP I 04-09).

(40)

Imported input materials are not transferable and have to be used to produce the resultant export product. The export obligation must be fulfilled within a prescribed time-frame after issuance of the licence (24 months with two possible extensions of six months each).

(41)

The verification showed that the actual consumption rate for the companies concerned of key raw materials needed to produce one kilogram of PET film was lower than the corresponding SION. This was clearly the case with regard to the old SION for PET film, and to a lesser extent, to the revised SION which came into force in September 2005.

(42)

The verification further established that none of the companies concerned had kept the legally required consumption register referred to in recital 37 above. Consequently, it can only be concluded that the verification requirements stipulated by the Indian authorities were not honoured.

(d)   Conclusion

(43)

The exemption from import duties is a subsidy within the meaning of Article 2(1)(a)(ii) and Article 2(2) of the basic Regulation, i.e. a financial contribution of the GOI which conferred a benefit upon the investigated exporters.

(44)

In addition, AAS physical exports, AAS for intermediate supply and AAS for annual requirement are clearly contingent in law upon export performance, and therefore deemed to be specific and countervailable under Article 3(4)(a) of the basic Regulation. Without an export commitment a company cannot obtain benefits under these schemes.

(45)

None of the three sub-schemes used in the present case can be considered as permissible duty drawback systems or substitution drawback systems within the meaning of Article 2(1)(a)(ii) of the basic Regulation. They do not conform to the rules laid down in Annex I item (i), Annex II (definition and rules for drawback) and Annex III (definition and rules for substitution drawback) of the basic Regulation. The GOI did not effectively apply neither its new nor its old verification system or procedure to confirm whether and in what amounts inputs were consumed in the production of the exported product (Annex II(II)(4) of the basic Regulation and, in the case of substitution drawback schemes, Annex III(II)(2) of the basic Regulation). The SIONs for the product concerned were not sufficiently precise. The SION’s themselves cannot be considered a verification system of actual consumption, because none of the companies concerned kept the required consumption register to enable the GOI to verify with sufficient precision what amounts of inputs were consumed in the export production. In addition, the GOI did not carry out a further examination based on actual inputs involved, although this would normally need to be carried out in the absence of an effectively applied verification system (Annex II(II)(5) and Annex III(II)(3) to the basic Regulation).

(46)

These three sub-schemes are therefore countervailable.

(e)   Calculation of the subsidy amount

(47)

In the absence of permitted duty drawback systems or substitution drawback systems, the countervailable benefit is the remission of total import duties normally due upon importation of inputs. In this respect, it is noted that the basic Regulation does not only provide for the countervailing of an ‘excess’ remission of duties. According to Article 2(1)(a)(ii) and Annex I(i) of the basic Regulation only when the conditions of Annexes II and III of the basic Regulation are met that the excess remission of duties can be countervailed. However, these conditions were not fulfilled in the present case. Thus, if an adequate monitoring process is not demonstrated, the above exception for drawback schemes is not applicable and the normal rule of the countervailing of the amount of unpaid duties (revenue forgone), applies, rather than of any purported excess remission. As set out in Annexes II(II) and III(II) of the basic Regulation the burden is not upon the investigating authority to calculate such excess remission. To the contrary, according to Article 2(1)(a)(ii) of the basic Regulation, the investigating authority only has to establish sufficient evidence to refute the appropriateness of an alleged verification system.

(48)

The subsidy amount for the three exporters which used the AAS was calculated on the basis of import duties forgone (basic customs duty and special additional customs duty) on the material imported under the three sub-schemes during the RIP (numerator). In accordance with Article 7(1)(a) of the basic Regulation, fees necessarily incurred to obtain the subsidy were deducted from the subsidy amount where justified claims were made. In accordance with Article 7(2) of the basic Regulation, this subsidy amount was allocated over the export turnover during the RIP as appropriate denominator, because the subsidy is contingent upon export performance and was not granted by reference to the quantities manufactured, produced, exported or transported.

(49)

Three cooperating exporting producers obtained benefits from this scheme during the RIP ranging from 0,5 % to 2,1 %.

3.   Duty Entitlement Passbook Scheme (DEPBS)

(a)   Legal Basis

(50)

The detailed description of the DEPBS is contained in paragraph 4.3 of the EXIM-policy 04-09 and in chapter 4 of the HOP I 04-09.

(b)   Eligibility

(51)

Any manufacturer-exporter or merchant-exporter is eligible for this scheme.

(c)   Practical implementation of the DEPBS

(52)

An eligible exporter can apply for DEPBS credits which are calculated as a percentage of the value of products exported under this scheme. Such DEPBS rates have been established by the Indian authorities for most products, including the product concerned. They are determined on the basis of SIONs, taking into account a presumed import content of inputs in the export product and the customs duty incidence on such presumed imports, regardless of whether import duties have actually been paid or not.

(53)

To be eligible for benefits under this scheme, a company must export. At the point in time of the export transaction, a declaration must be made by the exporter to the authorities in India indicating that the export is taking place under the DEPBS. In order for the goods to be exported, the Indian customs authorities issue an export shipping bill, during the dispatch procedure. This document shows, inter alia, the amount of DEPBS credit which is to be granted for that export transaction. At this point in time, the exporter knows the benefit it will receive. Once the customs authorities issue an export shipping bill, the GOI has no discretion over the granting of a DEPBS credit. The relevant DEPBS rate to calculate the benefit is that which applied at the time the export declaration is made. Therefore, there is no possibility for a retroactive amendment to the level of the benefit.

(54)

DEPBS credits are freely transferable and valid for a period of 12 months from the date of issue. They can be used for payment of customs duties on subsequent imports of any goods unrestrictedly importable, except capital goods. Goods imported against such credits can be sold on the domestic market (subject to sales tax) or used otherwise.

(55)

Application for DEPBS credits are electronically filed and can cover an unlimited amount of export transactions. De facto no strict deadlines apply to DEPBS credits. The electronic system used to manage DEPBS is not excluding automatically export transactions exceeding the deadline submission periods mentioned in chapter 4.47 HOP I 04-09. Furthermore, as clearly provided in chapter 9.3 HOP I 04-09 applications received after the expiry of submission deadlines can always be considered with the imposition of a minor penalty fee (i.e. 10 % on the entitlement).

(d)   Conclusions on the DEPBS

(56)

The DEPBS provides subsidies within the meaning of Article 2(1)(a)(ii) and Article 2(2) of the basic Regulation. A DEPBS credit is a financial contribution by the GOI, since the credit will eventually be used to offset import duties, thus decreasing the GOI’s duty revenue which would be otherwise due. In addition, the DEPBS credit confers a benefit upon the exporter, because it improves its liquidity.

(57)

Furthermore, the DEPBS is contingent in law upon export performance, and therefore deemed to be specific and countervailable under Article 3(4)(a) of the basic Regulation.

(58)

This scheme cannot be considered a permissible duty drawback system or substitution drawback system within the meaning of Article 2(1)(a)(ii) of the basic Regulation. It does not conform to the strict rules laid down in Annex I item (i), Annex II (definition and rules for drawback) and Annex III (definition and rules for substitution drawback) of the basic Regulation. An exporter is under no obligation to actually consume the goods imported free of duty in the production process and the amount of credit is not calculated in relation to actual inputs used. Moreover, there is no system or procedure in place to confirm which inputs are consumed in the production process of the exported product or whether an excess payment of import duties occurred within the meaning of item (i) of Annex I and Annexes II and III of the basic Regulation. Lastly, an exporter is eligible for the DEPBS benefits regardless of whether it imports any inputs at all. In order to obtain the benefit, it is sufficient for an exporter to simply export goods without demonstrating that any input material was imported. Thus, even exporters which procure all of their inputs locally and do not import any goods which can be used as inputs are still entitled to benefit from the DEPBS.

(e)   Calculation of the subsidy amount

(59)

In accordance with Articles 2(2) and 5 of the basic Regulation and the calculation methodology used for this scheme in Regulation (EC) No 367/2006, the amount of countervailable subsidies was calculated in terms of the benefit conferred on the recipient found to exist during the RIP. In this regard, it was considered that the benefit is conferred on the recipient at the point in time when an export transaction is made under this scheme. At this moment, the GOI is liable to forego the customs duties, which constitutes a financial contribution within the meaning of Article 2(1)(a)(ii) of the basic Regulation. Once the customs authorities issue an export shipping bill which shows, inter alia, the amount of DEPBS credit which is to be granted for that export transaction, the GOI has no discretion as to whether or not to grant the subsidy. Furthermore, the cooperating exporting producers booked the DEPBS credits on an accrual basis as income at the stage of the export transactions.

(60)

Where justified claims were made, fees necessarily incurred to obtain the subsidy were deducted from the credits so established to arrive at the subsidy amount as numerator, pursuant to Article 7(1)(a) of the basic Regulation. In accordance with Article 7(2) of the basic Regulation this subsidy amount has been allocated over the export turnover concerned during the review investigation period as appropriate denominator, because the subsidy is contingent upon export performance and it was not granted by reference to the quantities manufactured, produced, exported or transported.

(61)

Four cooperating exporting producers obtained benefits from this scheme during the RIP ranging from 2,7 % to 5,9 %.

4.   Export Promotion Capital Goods Scheme (EPCGS)

(a)   Legal basis

(62)

The detailed description of the EPCGS is contained in chapter 5 of the EXIM-policy 04-09 and in chapter 5 of the HOP I 04-09.

(b)   Eligibility

(63)

Manufacturer-exporters, merchant-exporters ‘tied to’ supporting manufacturers and service providers are eligible for this scheme.

(c)   Practical implementation

(64)

Under the condition of an export obligation, a company is allowed to import capital goods (new and — since April 2003 — second-hand capital goods up to 10 years old) at a reduced rate of duty. To this end, the GOI issues upon application and payment of a fee an EPCGS licence. Since April 2000, the scheme provides for a reduced import duty rate of 5 % applicable to all capital goods imported under the scheme. Until 31 March 2000, an effective duty rate of 11 % (including a 10 % surcharge) and, in case of high value imports, a zero duty rate was applicable. In order to meet the export obligation, the imported capital goods must be used to produce a certain amount of export goods during a certain period.

(65)

The EPCGS licence holder can also source the capital goods indigenously. In such case, the indigenous manufacturer of capital goods may avail of the benefit for duty-free import of components required to manufacture such capital goods. Alternatively, the indigenous manufacturer can claim the benefit of deemed export in respect of supply of capital goods to an EPCGS licence holder.

(d)   Disclosure comments

(66)

Following disclosure, one exporting producer highlighted that the capital goods imported under this scheme were also used for the production of products not concerned with this investigation, and that, when determining the subsidy margin, the subsidy amount established and attributable to the RIP should be divided by exports of not only the product concerned. This claim was found to be warranted and an appropriate adjustment was made in calculating the amount of benefit to this company under this scheme.

(e)   Conclusion on EPCG scheme

(67)

The EPCGS provides subsidies within the meaning of Article 2(1)(a)(ii) and Article 2(2) of the basic Regulation. The duty reduction constitutes a financial contribution by the GOI, since this concession decreases the GOI’s duty revenue, which would be otherwise due. In addition, the duty reduction confers a benefit upon the exporter, because the duties saved upon importation improve its liquidity.

(68)

Furthermore, the EPCGS is contingent in law upon export performance, since such licences can not be obtained without a commitment to export. Therefore, it is deemed to be specific and countervailable under Article 3(4)(a) of the basic Regulation.

(69)

Eventually, this scheme can not be considered a permissible duty drawback system or substitution drawback system within the meaning of Article 2(1)(a)(ii) of the basic Regulation. Capital goods are not covered by the scope of such permissible systems, as set out in Annex I, item (i), of the basic Regulation, because they are not consumed in the production of the exported products.

(f)   Calculation of the subsidy amount

(70)

The subsidy amount was calculated, in accordance with Article 7(3) of the basic Regulation, on the basis of the unpaid customs duty on imported capital goods spread across a period which reflects the normal depreciation period of such capital goods in the industry concerned. In accordance with the established practice, the amount so calculated, which is attributable to the RIP, has been adjusted by adding interest during this period in order to reflect the full value of the benefit over time. The commercial interest rate during the review investigation period in India was considered appropriate for this purpose. Where justified claims were made, fees necessarily incurred to obtain the subsidy were deducted in accordance with Articles 7(1)(a) of the basic Regulation. In accordance with Article 7(2) and 7(3) of the basic Regulation, this subsidy amount has been allocated over the export turnover during the RIP as appropriate denominator, because the subsidy is contingent upon export performance and it was not granted by reference to the quantities manufactured, produced, exported or transported.

(71)

Four cooperating exporting producers obtained benefits from this scheme during the RIP ranging from 1,0 % to 1,9 %.

5.   Export Processing Zones (EPZS)/Special Economic Zones Scheme (SEZS)/Export Oriented Units Scheme (EOUS)

(72)

It was found that none of the cooperating exporting producers had the status of an EOU nor were any of them located in an EPZS. However, one of the cooperating exporting producers was located in an SEZS and received countervailable subsidies in the RIP. The description and assessment below is therefore limited to the SEZS.

(a)   Legal basis

(73)

Chapter 7 of the EXIM-policy 04-09 and chapter 7 the HOP I 04-09 makes reference to SEZS. The details of the rules and provisions are no longer in the EXIM policy book and the Handbook of procedures. The relevant policy and implementation provisions are the Special Economic Zones Act of 2005 (No 28 of 2005) and the Special Economic Zones Rules of 2006 (Notification dated 10 February 2006).

(b)   Eligibility

(74)

All enterprises which, in principle, undertake to export their entire production of goods or services may be set up under the SEZS. This also includes pure trading companies. Unlike EOUS, there are no minimum investment thresholds in fixed assets which companies have to fulfil to be eligible for the SEZS.

(c)   Practical implementation

(75)

The SEZS is the successor scheme of the former Export Processing Zones Scheme (EPZS). SEZS are specifically delineated duty-free enclaves and considered as foreign territory for the purpose of trade operations, duties and taxes. SEZS units have to be located within specified zones developed for that purpose. Seventeen SEZS are already in operation following the approval of their establishment by the India authorities.

(76)

An application for SEZ status must include details for the next five years of, inter alia, planned production quantities, projected value of exports, import requirements and indigenous requirements. Upon acceptance by the authorities of the company’s application, the terms and conditions attached to this acceptance will be communicated to the company. The agreement to be recognised as a company under the SEZS is valid for a five-year period. The agreement may be renewed for further periods.

(77)

A crucial obligation for SEZS units as set out in Chapter VI of Special Economic Zones Rules of 2006 is to achieve Net Foreign Exchange (NFE) earnings, i.e. in a reference period (five years from the commencement of commercial production), the total value of exports has to be higher than the total value of imported goods.

(78)

SEZS units are entitled to the following concessions:

(i)

exemption from import duties on all types of goods (including capital goods, raw materials and consumables) required for the manufacture, production, processing, or in connection therewith;

(ii)

exemption from excise duty on goods procured from indigenous sources;

(iii)

exemption from central sales tax paid on goods procured locally;

(iv)

the facility to sell part of the production on the domestic market, subject to fulfilment of positive NFE earnings upon payment of applicable duties as the SEZS are not considered part of the Indian fiscal/customs territory;

(v)

100 % Income Tax Exemption on ‘profits from exports’ from SEZ units under Section 10AA of the Income Tax Act for the first five years, 50 % for the next five years thereafter and with the possibility for further benefits for the next five years; and

(vi)

exemption from service tax for services consumed in an SEZ.

(79)

Units operating under SEZS are bonded under the surveillance of customs officials in accordance with the relevant provisions of the Customs Act.

(80)

These units are legally obliged to maintain proper accounts which should indicate in value terms the goods imported or procured from the domestic tariff area, consumption and utilisation of goods, production of goods and disposal of goods by way of exports, sales in the domestic tariff area etc. in accordance with rule 22(2) of the Special Economic Zones Rules of 2006.

(81)

However, at no point in time is a SEZ unit required to co-relate every import consignment with its exports or transfers to other units, or with its sales in the domestic tariff area, according to rule 35 of the Special Economic Zones Rules of 2006.

(82)

The assessment of imports and domestic procurement of raw materials and capital goods is based on a self-certification basis. The same applies in case of export sales. Thus, no routine examinations of such consignments of an SEZ unit by customs authorities take place.

(83)

In the present case, the cooperating exporting producer utilised the scheme to import raw materials and capital goods free of import duties, to procure goods domestically free of excise duty, to procure goods domestically without payment of central sales tax, and to be exempted from service tax. The investigation showed that the exporting producer concerned did not avail of benefits under the income tax exemption provisions of the SEZS.

(d)   Disclosure comments

(84)

Following disclosure, the exporting producer located in an SEZS made a number of comments arguing e.g. that the sub-schemes used by the company are permissible duty exemption schemes (duty drawback) and that the sub-schemes used do not constitute a subsidy since they do not confer a benefit. The arguments of the exporting producer are addressed below.

(e)   Conclusions on the SEZS

(85)

In the case of exemption from excise duty on goods procured from indigenous sources, it was found that the duty paid on purchases by a non-SEZS unit can be used as a credit for its own future duty liabilities, e.g. towards payment of excise duty on domestic sales (the so-called ‘CENVAT’ mechanism). Therefore, the excise duty paid on purchases is not definitive. By the means of ‘CENVAT’-credit, only an added value bears a definitive duty, not the input materials. Thus, by granting an exemption from excise duty on purchases by an SEZS unit, no additional government revenue is forgone and consequently no additional benefit accrues to the SEZS. In these circumstances, as no additional benefit accrues to the SEZS it is not necessary to further analyse this sub-scheme in this investigation.

(86)

The exemption of a SEZS unit from two types of import duties (basic customs duty and special additional customs duty normally due on imports of raw materials and capital goods), the exemption from payment of sales tax on goods procured domestically and the exemption from service tax constitute subsidies within the meaning of Article 2(1)(a)(ii) of the basic Regulation. Government revenue which would be due in the absence of this scheme is forgone, thus conferring a benefit upon the SEZS unit within the meaning of Article 2(2) of the basic Regulation, because it improves its liquidity. The subsidies are contingent in law upon export performance and, therefore, deemed to be specific and countervailable under Article 3(4)(a) of the basic Regulation. The export objective of SEZS as set out in rule 2 of the Special Economic Zones Rules of 2006 is a conditio sine qua non to obtain the incentives.

(87)

The exporting producer argued that the sub-schemes used by the company constitute permissible duty exemption (duty drawback) schemes pursuant to Article 2(1)(a)(ii) and Annex I of the basic Regulation and are therefore not countervailable. The company submitted that Annex (i) to the basic Regulation provide that only the exemption, remission or drawback of import charges in excess of those levied on imported inputs that are consumed in the production of the exported product constitutes an export subsidy. In other words, as long as there is no excess remission or exemption, the exemption from imported duties on inputs required for the manufacture, production or processing of the exported product cannot be considered as a countervailable subsidy.

(88)

In reply to this argument, it should first of all be noted that the benefits an SEZ unit enjoys are all contingent in law upon export performance. Furthermore, the schemes cannot be considered as permissible duty drawback systems or substitution drawback systems within the meaning of Article 2(1)(a)(ii) of the basic Regulation. They do not conform to the strict rules laid down in Annex I (items (h) and (i)), Annex II (definition and rules for drawback) and Annex III (definition and rules for substitution drawback) of the basic Regulation. In the circumstance that the sales tax exemption and import duty exemption provisions are used for purchasing capital goods, they are already not in conformity with the rules for permitted drawback systems since capital goods are not consumed in the production process, as required by Annex I item (h) (sales tax reimbursement) and by Annex I item (i) (import duty remission). In addition, it was confirmed that the GOI has no effective verification system or procedure in place to confirm whether and in what amounts duty and or the tax free procured inputs were consumed in the production of the exported product (Annex II(II)(4) of the basic Regulation, and, in the case of substitution drawback schemes, Annex III(II)(2) of the basic Regulation). In fact, an SEZ unit is required to achieve Net Foreign Exchange (NFE) earnings, but there is no verification system in place aiming to monitor the consumption of imports in relation to the production of exported goods.

(89)

As an alternative argument, the exporting producer submitted that the sub-schemes used by the company do not constitute subsidies as no benefit had been conferred upon the company. With respect to domestic sales, the exporting producers argued that, since a SEZ unit is not considered to be part of the India fiscal/customs territory, full customs duties need to be paid on the finished products when sold to the domestic market. It was alleged that no benefit has been obtained since duties exempted on the inputs used in the production of goods sold on the domestic market are lower than the duties paid by the company when selling on the domestic market.

(90)

In addressing this claim, it should be noted that though the purpose for setting up as a SEZ unit is to achieve Net Foreign Exchange (NFE) earnings, the SEZ unit has the possibility to sell part of its production on the domestic market. Under the SEZ scheme, the goods cleared from the zone to the domestic market will be treated as imported goods. As such, an SEZ is not in a different situation than other companies operating on the domestic market, i.e. applicable duties/taxes would have to be paid on purchased goods. In this context, it should be clear that, a decision of the Government to tax goods for consumption on the domestic market, does not mean, that the exemption of a SEZS unit from import duties and sales taxes is not a benefit in relation to the export sales of the product concerned. Moreover, the sales on the domestic market have no impact on the more general assessment of the adequacy of whether there is an appropriate verification system in place.

(91)

In respect of export sales, the exporting producer argued that the exemption from import duties and taxes does not constitute a countervailable subsidy as long as there is no excess remission. The company further argues that the SEZ unit is bonded under surveillance of customs officials, and that it is not possible to sell inputs on the domestic market or to incorporate these inputs in products to be sold on the domestic market without paying the applicable duties. In the view of the exporting producer, there can be thus no excess remission.

(92)

In reply to this, it should be recalled that there is no system or procedure in place to confirm which inputs are consumed in the production process of the exported product and whether an excess payment of import duties and taxes occurred within the meaning of Annexes I, II and III to the basic Regulation. A SEZ unit is already de jure and at no point in time required to co-relate every import consignment with the destination of the corresponding resultant product. Only if such controls were in place would the Indian authorities be able to obtain sufficient information about the final destination of inputs so as to allow for an efficient check that the duty/sales tax exemptions do not exceed inputs for export production. Company internal systems would not as such suffice since a duty drawback verification system would need to be designed and enforced by a government. Consequently, the investigation has established that the SEZ is explicitly not required by the legal rules and provisions for SEZS to record nexus between imported materials and the finished product and no effective control mechanism was set up by the GOI to determine which inputs were consumed in export production and in what amounts.

(93)

Also, the GOI neither carried out a further examination based on actual inputs involved, although this would normally be required in the absence of an effective verification system (Annex II(II)(5) and Annex III(II)(3) to the basic Regulation). Furthermore, no evidence was provided by the GOI demonstrating that no excess remission took place.

(f)   Calculation of the subsidy amount

(94)

Accordingly, in the absence of a permitted duty drawback system or substitution drawback system, the countervailable benefit is the remission of customs duties (basic customs duty and special additional customs duty) the exemption from payment of sales tax for goods procured domestically and the exemption from service tax, during the investigation period.

(95)

As regards the exemption from payment of basic customs duties, the exemption from payment of sales tax for goods procured domestically and the exemption from service tax, the numerator (subsidy amount) was calculated on the basis of the exempted amounts during the RIP. Fees necessarily incurred to obtain the subsidy were deducted in accordance with Article 7(1)(a) of the basic Regulation from this sum to arrive at the subsidy amount as the numerator.

(96)

Unlike raw materials, capital goods are not physically incorporated into the finished goods. Accordingly, in regard to exemptions from payment of taxes on purchases of capital goods, the subsidy amount was calculated, in accordance with Article 7(3) of the basic Regulation, on the basis of the unpaid customs duty on imported capital goods spread across a period which reflects the normal depreciation period of such capital goods in the industry concerned. In accordance with the established practice, the amount so calculated, which is attributable to the RIP, has been adjusted by adding interest during this period in order to reflect the full value of the benefit over time. The commercial interest rate during the RIP in India was considered appropriate for this purpose. Where substantiated claims were made, fees necessarily incurred to obtain the subsidy were deducted in accordance with Article 7(1)(a) of the basic Regulation.

(97)

In accordance with Article 7(2) of the basic Regulation these subsidy amounts thus established under recital 95 and recital 96 above were allocated over the export turnover generated during the RIP as the appropriate denominator, because the subsidy is contingent upon export performance and it was not granted by reference to the quantities manufactured, produced, exported or transported. The subsidy margin thus obtained was 5,4 %.

6.   Income Tax Exemption Scheme (ITES)

(98)

Under this scheme exporters could avail the benefit of a partial income tax exemption on profits derived from export sales. The legal basis for this exemption was set by Section 80HHC of the ITA.

(99)

This provision was abolished for the assessment year 2005-2006 (i.e. for the financial year from 1 April 2004 to 31 March 2005) onwards and thus 80HHC of the ITA does not confer any benefits after 31 March 2004. The cooperating exporting producers did not avail any benefits under this scheme during the RIP. Consequently, since the scheme has been withdrawn, it shall therefore not be countervailed, in accordance with Article 15(1) of the basic Regulation.

7.   Export Credit Scheme (ECS)

(a)   Legal basis

(100)

The details of the scheme are set out in the Master Circular DBOD No DIR.(Exp).BC 02/04.02.02/2007-08 (Export Credit in Foreign Currency) and the Master Circular DBOD No DIR.(Exp).BC 01/04.02.02/2007-08 (Rupee Export Credit) of the Reserve Bank of India (RBI), which is addressed to all commercial banks in India.

(b)   Eligibility

(101)

Manufacturing exporters and merchant exporters are eligible for this scheme. It was established that three of the exporting producers availed of benefits under the ECS.

(c)   Practical implementation

(102)

Under this scheme, the RBI mandatorily sets maximum ceiling interest rates applicable to export credits, both in Indian rupees or in foreign currency, which commercial banks can charge an exporter. The ECS consists of two sub-schemes, the Pre-Shipment Export Credit Scheme (packing credit), which covers credits provided to an exporter for financing the purchase, processing, manufacturing, packing and/or shipping of goods prior to export, and the Post-Shipment Export Credit Scheme, which provides for working capital loans with the purpose of financing export receivables. The RBI also directs the banks to provide a certain amount of their net bank credit towards export finance.

(103)

As a result of the RBI Master Circulars exporters can obtain export credits at preferential interest rates as compared with the interest rates for ordinary commercial credits (cash credits), which are purely set under market conditions. The difference in rates might decrease for companies with good credit ratings. In fact, high rating companies might be in a position to obtain export credits and cash credits at the same conditions.

(d)   Conclusion on the ECS

(104)

The preferential interest rates of an ECS credit set by the RBI Master Circulars mentioned in recital 100 can decrease the interest costs of an exporter as compared with credit costs purely set by market conditions and confer in this case a benefit in the meaning of Article 2(2) of the basic Regulation on such exporter. Export financing is not per se more secure than domestic financing. In fact, it is usually perceived as being more risky and the extent of security required for a certain credit, regardless of the finance object, is a purely commercial decision of a given commercial bank. Rate differences with regard to different banks are the result of the methodology of the RBI to set maximum lending rates for each commercial bank individually. In addition, commercial banks would not be obliged to pass through to borrowers of export financing any more advantageous interest rates for export credits in foreign currency.

(105)

Despite the fact that the preferential credits under the ECS are granted by commercial banks, this benefit is a financial contribution by a government within the meaning of Article 2(1)(a)(iv) of the Regulation. In this context, it should be noted that neither Article 2(1)(a)(iv) of the basic Regulation nor the ASCM require a charge on the public accounts, e.g. reimbursement of the commercial banks by the GOI, to establish a subsidy, but only government direction to carry out functions illustrated in points (i), (ii) or (iii) of Article 2(1)(a) of the basic Regulation. The RBI is a public body and falls therefore under the definition of ‘government’ as set out in Article 1(3) of the basic Regulation. It is 100 % government-owned, pursues public policy objectives, e.g. monetary policy, and its management is appointed by the GOI. The RBI directs private bodies, within the meaning of the second indent of Article 2(1)(a)(iv) of the basic Regulation, since the commercial banks are bound by the conditions it imposes, inter alia, with regard to the maximum ceilings for interest rates on export credits mandated in the RBI Master Circulars and the RBI provisions that commercial banks have to provide a certain amount of their net bank credit towards export finance. This direction obliges commercial banks to carry out functions mentioned in Article 2(1)(a)(i) of the basic Regulation, in this case provide loans in the form of preferential export financing. Such direct transfer of funds in the form of loans under certain conditions would normally be vested in the government, and the practice differs, in no real sense, from practices normally followed by governments, within the meaning of Article 2(1)(a)(iv) of the basic Regulation. This subsidy is deemed to be specific and countervailable since the preferential interest rates are only available in relation to the financing of export transactions and are therefore contingent upon export performance, pursuant to Article 3(4)(a) of the basic Regulation.

(e)   Calculation of the subsidy amount

(106)

The subsidy amount has been calculated on the basis of the difference between the interest paid for export credits used during the RIP and the amount that would have been payable for ordinary commercial credits used by the cooperating exporting producers. This subsidy amount (numerator) has been allocated over the export turnover during the RIP as appropriate denominator in accordance with Article 7(2) of the basic Regulation, because the subsidy is contingent upon export performance and it was not granted by reference to the quantities manufactured, produced, exported or transported.

(107)

Three cooperating exporting producers obtained benefits from this scheme during the RIP ranging from 0,3 % to 0,4 %.

8.   Package Scheme of Incentives (PSI)

(a)   Legal basis

(108)

In previous investigations regarding PET film, including the review investigation that led to the imposition by Regulation (EC) No 367/2006 of the definitive countervailing duty currently in force, several Indian State schemes involving incentives granted to local companies were investigated. The State schemes fall under the heading ‘Package Scheme of Incentives’ (PSI), as there can be different kind of incentives involved. The investigation established that a company’s entitlement to benefits under the scheme is stipulated in the ‘Eligibility Certificate’. The investigation revealed that two of the cooperating producers enjoyed trade tax (sales tax) exemption under the PSI during the RIP pursuant to Section 4A of the State of Uttar Pradesh Trade Tax Act. This tax provision excuses home-market sales by a company from payment of sales tax (both local sales tax and central sales tax).

(b)   Eligibility

(109)

In order to be eligible, companies must as a general rule invest in less developed areas of a state either by setting up a new industrial establishment or by making a large scale capital investment in expansion or diversification of an existing industrial establishment. The main criterion to establish the amount of incentives is the classification of the area in which the enterprise is or will be located and the size of the investment.

(c)   Practical implementation

(110)

Under the sales tax exemption schemes, designated units were not required to collect any sales tax on their sales transactions. Similarly, designated units were exempted from the payment of sales tax on their purchases of goods from suppliers eligible for the schemes. Whereas the exemption in relation to sales transaction is not considered to confer any benefit on the designated sales units, the exemption in relation to purchase transactions, however, does confer a benefit on the designated purchasing units.

(d)   Disclosure comments

(111)

Following disclosure, one exporting producer noted that, when quantifying the benefit received under this scheme, it has been considered that the suppliers of a main raw material used in the production of the product concerned enjoyed exemption from sales tax. The sales invoices, however, revealed that the suppliers in question did, in fact, charge the tax on their sales to the company concerned. Consequently, as the sales tax was paid by the company, no countervailable benefit arose for the exporting producer on these purchases, and the amount of subsidy was revised accordingly.

(e)   Conclusion

(112)

The PSI provides subsidies within the meaning of Article 2(1)(a)(ii) and Article 2(2) of the basic Regulation. The exemption from payment of sales taxes on purchases constitutes a financial contribution, since this concession decreases the government’s revenue which would be otherwise due. In addition, this exemption confers a benefit upon the companies as it improves their liquidity.

(113)

The PSI is only available to companies having invested within certain designated geographical areas within the jurisdiction of a State in India. It is not available for companies located outside these areas. The level of benefit is different according to the area concerned. The scheme is specific in accordance with Article 3(2)(a) and Article 3(3) of the basic Regulation and therefore countervailable.

(f)   Calculation of the subsidy amount

(114)

Concerning the sales tax exemption, the subsidy amount was calculated on the basis of the amount of the sales tax normally due during the RIP but which remained unpaid.

(115)

Pursuant to Article 7(2) of the basic Regulation, the amount of subsidy (numerator) has then been allocated over the total turnover of export and domestic sales during the review investigation period as the appropriate denominator, because the subsidy is not export-contingent and it was not granted by reference to the quantities manufactured, produced, exported or transported.

(116)

The two cooperating exporting producers obtained subsidies from this scheme during the RIP of 0,3 % and 1,4 % respectively.

9.   Amount of countervailable subsidies

(117)

It is recalled that in Regulation (EC) No 367/2006 and subsequent amendments, referred to in recitals 2, 3 and 4 above, the amount of countervailable subsidies, expressed ad valorem, was found to be ranging from 12 % to 19,1 % for the concerned cooperating exporting producers that cooperated in the present partial interim review.

(118)

During the present partial interim review the amount of countervailable subsidies, expressed ad valorem, was found to be ranging from 5,4 % to 8,6 %, as listed hereunder:

Scheme→

AAS (12)

DEPBS (12)

EPCGS (12)

SEZS (12)

ECS (12)

PSI

Total

Company↓

%

%

%

%

%

%

%

Ester Industries Limited

 

5,8

1,0

 

0,4

 

7,2

Garware Polyester Limited

0,5

3,9

1,0

 

Negligible

 

5,4

Polyplex Corporation Limited

1,7

3,2

1,9

 

0,4

1,4

8,6

SRF Limited

 

 

 

5,4

 

 

5,4

Uflex Limited

2,1

2,7

1,0

 

0,3

0,3

6,4

10.   Countervailing measures

(119)

In line with the provisions of Article 19 of the basic Regulation and the grounds of this partial interim review stated under point 3 of the Notice of Initiation, it is established that the level of subsidisation with regard to the concerned exporting producers has decreased and, therefore, the rates of countervailing duties imposed to these exporting producers by Regulation (EC) No 367/2006 should be amended accordingly.

(120)

The amended countervailing duty rates should be established at the new rates of subsidisation found during the present interim review, as the injury margins calculated in the original anti-subsidy investigation remains higher.

(121)

With regard to all other companies that were not concerned by the present partial interim review, it is noted that the actual modalities of the investigated schemes and their countervailability have not changed with respect to the previous investigation. Thus there is no reason to recalculate the subsidy and duty rates of these companies. Consequently, the rates of the duty applicable to all other parties except the five exporting producers that cooperated in the current review remain unchanged.

(122)

The individual company countervailing duty rates specified in this Regulation reflect the situation found during the partial interim review. Thus, they are solely applicable to imports of the product concerned produced by these companies. Imports of the product concerned manufactured by any other company not specifically mentioned in the operative part of this Regulation, including entities related to those specifically mentioned, cannot benefit from these rates and shall be subject to the duty rate applicable to ‘all other companies’.

(123)

Any claim requesting the application of these individual countervailing duty rates (e.g. following a change in the name of the entity or following the setting up of new production or sales entities) should be addressed to the Commission (13) forthwith with all relevant information, in particular any modification in the company’s activities linked to production, domestic and export sales associated with, for instance, that name change or that change in the production and sales entities. If appropriate, and after consultation of the Advisory Committee, the Regulation will be amended accordingly by updating the list of companies benefiting from individual duty rates.

11.   Anti-dumping measures

(124)

As provided in the last paragraph under point 3 of the Notice of Initiation, the amendment of the countervailing duty rate will have an impact on the definitive anti-dumping duty imposed by Regulation (EC) No 1292/2007, as the latter in previous anti-dumping investigations was adjusted in order to avoid any double counting of the effects of benefits from export subsidies (it is recalled that the definitive anti-dumping duty was based on the dumping margin since the latter was found to be lower than the injury elimination level). Article 24(1) of the basic Regulation and Article 14(1) of Regulation (EC) No 384/96 provide that no product shall be subject to both anti-dumping and countervailing measures for the purpose of dealing with one and the same situation arising from dumping or export subsidisation. It was found in the original investigation that certain of the subsidy schemes investigated which were countervailable, constituted export subsidies within the meaning of Article 3(4)(a) of the basic Regulation. As such, these subsidies affected the export prices of the Indian exporting producers, thus leading to increased margins of dumping. Therefore, pursuant to Article 24(1) of the basic Regulation, the definitive anti-dumping duty rates were adjusted to reflect the actual dumping margin remaining after the imposition of the definitive countervailing duty offsetting the effect of the export subsidies (see recital 59 of Regulation (EC) No 366/2006 and recital 11 of Regulation (EC) No 1424/2006).

(125)

Consequently, the definitive anti-dumping duty rates for the exporting producers concerned must now be adjusted to take account of the revised level of benefit received from export subsidies in the RIP of the current anti-subsidy investigation to reflect the actual dumping margin remaining after the imposition of the adjusted definitive countervailing duty offsetting the effect of the export subsidies.

(126)

The dumping margins previously established in respect of Ester Industries Limited, Garware Polyester Limited, Polyplex Corporation Limited and Uflex Limited (at that time known as Flex Industries Limited) (14), were established in Regulation (EC) No 366/2006 (see recital 50) and amounted for the four companies concerned to 29,3 %, 20,1 %, 3,7 % and 3,2 % respectively. The level of the dumping margin for SRF Limited established in Regulation (EC) No 1424/2006 was 15,5 %.

(127)

Taking into the account the benefits from exports subsidies found in the RIP and the level of the dumping margin previously established, the margins and duty rates applicable to the companies concerned should therefore be calculated as indicated in the table below:

Company

Export subsidy margin

Total subsidy margin

Dumping margin previously established

CVD duty

AD duty

Total duty rate

Ester Industries Limited

7,2 %

7,2 %

29,3 %

7,2 %

22,1 %

29,3 %

Garware Polyester Limited

5,4 %

5,4 %

20,1 %

5,4 %

14,7 %

20,1 %

Polyplex Corporation Limited

7,2 %

8,6 %

3,7 %

8,6 %

0,0 %

8,6 %

SRF Limited

5,4 %

5,4 %

15,5 %

5,4 %

10,1 %

15,5 %

Uflex Limited

6,1 %

6,4 %

3,2 %

6,4 %

0,0 %

6,4 %

(128)

In order to take account of the revised level of anti-dumping duty for the five exporting producers concerned, Regulation (EC) No 1292/2007 should be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 1(2) of Regulation (EC) No 367/2006 shall be replaced by the following:

‘2.   The rate of the definitive countervailing duty applicable to the net free-at-Community-frontier price, before duty, of the products manufactured by the companies listed below, shall be as follows:

Company

Definitive duty (%)

TARIC additional code

Ester Industries Limited, 75-76, Amrit Nagar, Behind South Extension Part-1, New Delhi 110 003, India

7,2

A026

Garware Polyester Limited, Garware House, 50-A, Swami Nityanand Marg, Vile Parle (East), Mumbai 400 057, India

5,4

A028

Jindal Poly Films Limited, 56 Hanuman Road, New Delhi 110 001, India

17,1

A030

MTZ Polyfilms Limited, New India Centre, 5th Floor, 17 Co-operage Road, Mumbai 400 039, India

8,7

A031

Polyplex Corporation Limited, B-37, Sector-1, Noida 201 301, Dist. Gautam Budh Nagar, Uttar Pradesh, India

8,6

A032

SRF Limited, Block C, Sector 45, Greenwood City, Gurgaon 122 003, Haryana, India

5,4

A753

Uflex Limited, A-1, Sector 60, Noida 201 301 (U.P.), India

6,4

A027

All other companies

19,1

A999’

Article 2

Article 2(2) of Regulation (EC) No 1292/2007 shall be replaced by the following:

‘2.   The rate of the definitive anti-dumping duty applicable to the net, free-at-Community-frontier price, before duty, of the products manufactured by the companies listed below, shall be as follows:

Company

Definitive duty (%)

TARIC additional code

Ester Industries Limited, 75-76, Amrit Nagar, Behind South Extension Part-1, New Delhi 110 003, India

22,1

A026

Garware Polyester Limited, Garware House, 50-A, Swami Nityanand Marg, Vile Parle (East), Mumbai 400 057, India

14,7

A028

Jindal Poly Films Limited, 56 Hanuman Road, New Delhi 110 001, India

0,0

A030

MTZ Polyfilms Limited, New India Centre, 5th Floor, 17 Co-operage Road, Mumbai 400 039, India

18,0

A031

Polyplex Corporation Limited, B-37, Sector-1, Noida 201 301, Dist. Gautam Budh Nagar, Uttar Pradesh, India

0,0

A032

SRF Limited, Block C, Sector 45, Greenwood City, Gurgaon 122 003, Haryana, India

10,1

A753

Uflex Limited, A-1, Sector 60, Noida 201 301 (U.P.), India

0,0

A027

All other companies

17,3

A999’

Article 3

This Regulation shall enter into force on the day following 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, 8 January 2009.

For the Council

The President

K. SCHWARZENBERG


(1)  OJ L 288, 21.10.1997, p. 1.

(2)  OJ L 316, 10.12.1999, p. 1.

(3)  OJ L 68, 8.3.2006, p. 15.

(4)  OJ L 236, 31.8.2006, p. 1.

(5)  OJ L 255, 29.9.2007, p. 1.

(6)  OJ L 227, 23.8.2001, p. 1.

(7)  OJ L 68, 8.3.2006, p. 6.

(8)  OJ L 270, 29.9.2006, p. 1.

(9)  OJ L 288, 6.11.2007, p. 1.

(10)  OJ L 56, 6.3.1996, p. 1.

(11)  OJ C 240, 12.10.2007, p. 6.

(12)  Subsidies marked with an asterisk are export subsidies.

(13)  European Commission, Directorate General for Trade — Directorate B, N105, 04/90, Rue de la Loi/Wetstraat 200, 1049 Brussels, Belgium.

(14)  OJ L 68, 8.3.2006, p. 6.


10.1.2009   

EN

Official Journal of the European Union

L 6/18


COMMISSION REGULATION (EC) No 16/2009

of 9 January 2009

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,

Whereas:

Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XV, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 10 January 2009.

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

Done at Brussels, 9 January 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 350, 31.12.2007, p. 1.


ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

58,7

TR

104,0

ZZ

81,4

0707 00 05

JO

167,2

MA

88,6

TR

147,0

ZZ

134,3

0709 90 70

MA

87,0

TR

158,3

ZZ

122,7

0805 10 20

BR

44,6

CL

44,1

EG

52,5

IL

54,2

MA

55,0

TR

78,3

ZA

44,1

ZZ

53,3

0805 20 10

MA

69,0

ZZ

69,0

0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

CN

49,4

IL

69,6

TR

82,2

ZZ

67,1

0805 50 10

EG

47,1

MA

58,4

TR

65,3

ZZ

56,9

0808 10 80

CN

83,6

MK

35,0

US

116,4

ZZ

78,3

0808 20 50

CN

68,2

US

119,1

ZZ

93,7


(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


DIRECTIVES

10.1.2009   

EN

Official Journal of the European Union

L 6/20


COMMISSION DIRECTIVE 2008/128/EC

of 22 December 2008

laying down specific purity criteria concerning colours for use in foodstuffs

(Codified version)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,

Whereas:

(1)

Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

(2)

It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (4).

(3)

It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(4)

Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

(5)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

(6)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto.

Article 2

Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 22 December 2008.

For the Commission

The President

José Manuel BARROSO


(1)  OJ L 40, 11.2.1989, p. 27.

(2)  OJ L 226, 22.9.1995, p. 1.

(3)  See Annex II, Part A.

(4)  OJ L 237, 10.9.1994, p. 13.


ANNEX I

A.   GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS

Definition

Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.

HCl insoluble matter

Not more than 0,5 %

Ether extractable matter

Not more than 0,2 % (under neutral conditions)

Specific purity criteria for the corresponding colours are applicable.

B.   SPECIFIC CRITERIA OF PURITY

E 100 CURCUMIN

Synonyms

CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane

Definition

Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occuring in turmeric may be present.

Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane.

Class

Dicinnamoylmethane

Colour Index No

75300

Einecs

207-280-5

Chemical names

I

1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione

II

1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione

III

1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione

Chemical formula

I

C21H20O6

II

C20H18O5

III

C19H16O4

Molecular weight

I.

368,39

II.

338,39

III.

308,39

Assay

Content not less than 90 % total colouring matters

E1 cm 1 %1 607 at ca 426 nm in ethanol

Description

Orange-yellow crystalline powder

Identification

A.

Spectrometry

Maximum in ethanol at ca 426 nm

B.

Melting Range

179 °C-182 °C

Purity

Solvent residues

Ethylacetate

Acetone

n-butanol

Methanol

Ethanol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 101 (i) RIBOFLAVIN

Synonyms

Lactoflavin

Class

Isoalloxazine

Einecs

201-507-1

Chemical names

7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione

7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine

Chemical formula

C17H20N4O6

Molecular weight

376,37

Assay

Content not less than 98 % on the anhydrous basis

E1 cm 1 % 328 at ca 444 nm in aqueous solution

Description

Yellow to orange-yellow crystalline powder, with slight odour

Identification

A.

Spectrometry

The ratio A375/A267 is between 0,31 and 0,33

The ratio A444/A267 is between 0,36 and 0,39

in aqueous solution

Maximum in water at ca 444 nm

B.

Specific rotation

[α]D20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution

Purity

Loss on drying

Not more than 1,5 % after drying at 105 °C for 4 hrs

Sulfated ash

Not more than 0,1 %

Primary aromatic amines

Not more than 100 mg/kg (calculated as aniline)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE

Synonyms

Riboflavin-5′-phosphate sodium

Definition

These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate

Class

Isoalloxazine

Einecs

204-988-6

Chemical names

Monosodium

(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate;

monosodium salt of 5′-monophosphate ester of riboflavin

Chemical formula

For the dihydrate form

:

C17H20N4NaO9P·2H2O

For the anhydrous form

:

C17H20N4NaO9P

Molecular weight

541,36

Assay

Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2O

E1 cm 1 % 250 at ca 375 nm in aqueous solution

Description

Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste

Identification

A.

Spectrometry

The ratio A375/A267 is between 0,30 and 0,34

The ratio A444/A267 is between 0,35 and 0,40

in aqueous solution

Maximum in water at ca 444 nm

B.

Specific rotation

[α]D20 between + 38° and + 42° in a 5 molar HCl solution

Purity

Loss on drying

Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form

Sulfated ash

Not more than 25 %

Inorganic phosphate

Not more than 1,0 % (calculated as PO4 on the anhydrous basis)

Subsidiary colouring matters

Riboflavin (free)

:

Not more than 6 %

Riboflavine diphosphate

:

Not more than 6 %

Primary aromatic amines

Not more than 70 mg/kg (calculated as aniline)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 102 TARTRAZINE

Synonyms

CI Food Yellow 4

Definition

Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

19140

Einecs

217-699-5

Chemical names

Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate

Chemical formula

C16H9N4Na3O9S2

Molecular weight

534,37

Assay

Content not less than 85 % total colouring matters calculated as the sodium salt

E1 cm 1 % 530 at ca 426 nm in aqueous solution

Description

Light orange powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 426 nm

B.

Yellow solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 1,0 %

Organic compounds other than colouring matters:

 

 

4-hydrazinobenzene sulfonic acid

 

4-aminobenzene-1-sulfonic acid

 

5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid

 

4,4′-diazoaminodi(benzene sulfonic acid)

 

Tetrahydroxysuccinic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 104 QUINOLINE YELLOW

Synonyms

CI Food Yellow 13

Definition

Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Chinophthalone

Colour Index No

47005

Einecs

305-897-5

Chemical name

The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)

Chemical formula

C18H9N Na2O8S2 (principal component)

Molecular weight

477,38 (principal component)

Assay

Content not less than 70 % total colouring matters calculated as the sodium salt

Quinoline Yellow shall have the following composition:

Of the total colouring matters present:

not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates

not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates

not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate

E1 cm 1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution

Description

Yellow powder or granules

Identification

A.

Spectrometry

Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm

B.

Yellow solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 4,0 %

Organic compounds other than colouring matters:

 

 

2-methylquinoline

 

2-methylquinoline-sulfonic acid

 

Phthalic acid

 

2,6-dimethyl quinoline

 

2,6-dimethyl quinoline sulfonic acid

Total not more than 0,5 %

2-(2-quinolyl)indan-1,3-dione

Not more than 4 mg/kg

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 110 SUNSET YELLOW FCF

Synonyms

CI Food Yellow 3, Orange Yellow S

Definition

Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

15985

Einecs

220-491-7

Chemical names

Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate

Chemical formula

C16H10N2Na2O7S2

Molecular weight

452,37

Assay

Content not less than 85 % total colouring matters calculated as the sodium salt

E1 cm 1 % 555 at ca 485 nm in aqueous solution at pH 7

Description

Orange-red powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 485 nm at pH 7

B.

Orange solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 5,0 %

1-(Phenylazo)-2-naphthalenol (Sudan I)

Not more than 0,5 mg/kg

Organic compounds other than colouring matters:

 

 

4-aminobenzene-1-sulfonic acid

 

3-hydroxynaphthalene-2,7-disulfonic acid

 

6-hydroxynaphthalene-2-sulfonic acid

 

7-hydroxynaphthalene-1,3-disulfonic acid

 

4,4′-diazoaminodi(benzene sulfonic acid)

 

6,6′-oxydi(naphthalene-2-sulfonic acid)

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 120 COCHINEAL, CARMINIC ACID, CARMINES

Definition

Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa.

The colouring principle is carminic acid.

Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.

In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.

Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.

Class

Anthraquinone

Colour Index No

75470

Einecs

Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4

Chemical names

7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid

Chemical formula

C22H20O13 (carminic acid)

Molecular weight

492,39 (carminic acid)

Assay

Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.

Description

Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.

Identification

Spectrometry

Maximum in aqueous ammonia solution at ca 518 nm

Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid

Purity

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 122 AZORUBINE, CARMOISINE

Synonyms

CI Food Red 3

Definition

Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

14720

Einecs

222-657-4

Chemical name

Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate

Chemical formula

C20H12N2Na2O7S2

Molecular weight

502,44

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 510 at ca 516 nm in aqueous solution

Description

Red to maroon powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 516 nm

B.

Red solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 2,0 %

Organic compounds other than colouring matters:

 

 

4-aminonaphthalene-1-sulfonic acid

 

4-hydroxynaphthalene-1-sulfonic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 123 AMARANTH

Synonyms

CI Food Red 9

Definition

Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

16185

Einecs

213-022-2

Chemical name

Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate

Chemical formula

C20H11N2Na3O10S3

Molecular weight

604,48

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 440 at ca 520 nm in aqueous solution

Description

Reddish-brown powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 520 nm

B.

Red solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 3,0 %

Organic compounds other than colouring matters:

 

 

4-aminonaphthalene-1-sulfonic acid

 

3-hydroxynaphthalene-2,7-disulfonic acid

 

6-hydroxynaphthalene-2-sulfonic acid

 

7-hydroxynaphthalene-1,3-disulfonic acid

 

7-hydroxynaphthalene-1,3-6-trisulfonic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 124 PONCEAU 4R, COCHINEAL RED A

Synonyms

CI Food Red 7, New Coccine

Definition

Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

16255

Einecs

220-036-2

Chemical name

Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate

Chemical formula

C20H11N2Na3O10S3

Molecular weight

604,48

Assay

Content not less than 80 % total colouring matters, calculated as the sodium salt.

E1 cm 1 % 430 at ca 505 nm in aqueous solution

Description

Reddish powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 505 nm

B.

Red solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 1,0 %

Organic compounds other than colouring matters:

 

 

4-aminonaphthalene-1-sulfonic acid

 

7-hydroxynaphthalene-1,3-disulfonic acid

 

3-hydroxynaphthalene-2,7-disulfonic acid

 

6-hydroxynaphthalene-2-sulfonic acid

 

7-hydroxynaphthalene-1,3-6-trisulfonic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 127 ERYTHROSINE

Synonyms

CI Food Red 14

Definition

Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.

Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Xanthen

Colour Index No

45430

Einecs

240-474-8

Chemical name

Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate

Chemical formula

C20H6I4Na2O5.H2O

Molecular weight

897,88

Assay

Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt

E1 cm 1 %1 100 at ca 526 nm in aqueous solution at pH 7

Description

Red powder or granules.

Identification

A.

Spectrometry

Maximum in water at ca 526 nm at pH 7

B.

Red solution in water

 

Purity

Inorganic iodides calculated as sodium iodide

Not more than 0,1 %

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters (except fluorescein)

Not more than 4,0 %

Fluorescein

Not more than 20 mg/kg

Organic compounds other than colouring matters:

 

Tri-iodoresorcinol

Not more than 0,2 %

2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid

Not more than 0,2 %

Ether extractable matter

From a solution of pH from 7 through 8, not more than 0,2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

Aluminium Lakes

The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only.

E 128 RED 2G

Synonyms

CI Food Red 10, Azogeranine

Definition

Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

18050

Einecs

223-098-9

Chemical name

Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate

Chemical formula

C18H13N3Na2O8S2

Molecular weight

509,43

Assay

Content not less than 80 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 620 at ca 532 nm in aqueous solution

Description

Red powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 532 nm

B.

Red solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 2,0 %

Organic compounds other than colouring matters:

 

 

5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid

 

5-amino-4-hydroxynaphthalene-2,7-disulfonic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 129 ALLURA RED AC

Synonyms

CI Food Red 17

Definition

Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Monoazo

Colour Index No

16035

Einecs

247-368-0

Chemical name

Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate

Chemical formula

C18H14N2Na2O8S2

Molecular weight

496,42

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 540 at ca 504 nm in aqueous solution at pH 7

Description

Dark red powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 504 nm

B.

Red solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 3,0 %

Organic compounds other than colouring matters:

 

6-hydroxy-2-naphthalene sulfonic acid, sodium salt

Not more than 0,3 %

4-amino-5-methoxy-2-methylbenezene sulfonic acid

Not more than 0,2 %

6,6-oxybis (2-naphthalene sulfonic acid) disodium salt

Not more than 1,0 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

From a solution of pH 7, not more than 0,2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 131 PATENT BLUE V

Synonyms

CI Food Blue 5

Definition

Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components.

The potassium salt is also permitted.

Class

Triarylmethane

Colour Index No

42051

Einecs

222-573-8

Chemical names

The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt

Chemical formula

Calcium compound: C27H31N2O7S2Ca Formula

Sodium compound: C27H31N2O7S2Na

Molecular weight

Calcium compound: 579,72

Sodium compound: 582,67

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 %2 000 at ca 638 nm in aqueous solution at pH 5

Description

Dark-blue powder or granules

Identification

A.

Spectrometry

Maximum in water at 638 nm at pH 5

B.

Blue solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 2,0 %

Organic compounds other than colouring matters:

 

 

3-hydroxy benzaldehyde

 

3-hydroxy benzoic acid

 

3-hydroxy-4-sulfobenzoic acid

 

N,N-diethylamino benzene sulfonic acid

Total not more than 0,5 %

Leuco base

Not more than 4,0 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

From a solution of pH 5 not more than 0,2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 132 INDIGOTINE, INDIGO CARMINE

Synonyms

CI Food Blue 1

Definition

Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Indigoid

Colour Index No

73015

Einecs

212-728-8

Chemical names

Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate

Chemical formula

C16H8N2Na2O8S2

Molecular weight

466,36

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt;

disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %

E1 cm 1 % 480 at ca 610 nm in aqueous solution

Description

Dark-blue powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 610 nm

B.

Blue solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %

Organic compounds other than colouring matters:

 

 

Isatin-5-sulfonic acid

 

5-sulfoanthranilic acid

 

Anthranilic acid

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 133 BRILLIANT BLUE FCF

Synonyms

CI Food Blue 2

Definition

Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Triarylmethane

Colour Index No

42090

Einecs

223-339-8

Chemical names

Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate

Chemical formula

C37H34N2Na2O9S3

Molecular weight

792,84

Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 %1 630 at ca 630 nm in aqueous solution

Description

Reddish-blue powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 630 nm

B.

Blue solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 6,0 %

Organic compounds other than colouring matters:

 

Sum of 2-, 3- and 4-formyl benzene sulfonic acids

Not more than 1,5 %

3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid

Not more than 0,3 %

Leuco base

Not more than 5,0 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % at pH 7

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 140 (i) CHLOROPHYLLS

Synonyms

CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin

Definition

Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

Class

Porphyrin

Colour Index No

75810

Einecs

Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4

Chemical names

The major colouring principles are:

 

Phytyl (132 R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)

 

Phytyl (132 R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)

Chemical formula

Chlorophyll a (magnesium complex): C55H72MgN4O5

Chlorophyll a: C55H74N4O5

Chlorophyll b (magnesium complex): C55H70MgN4O6

Chlorophyll b: C55H72N4O6

Molecular weight

Chlorophyll a (magnesium complex): 893,51

Chlorophyll a: 871,22

Chlorophyll b (magnesium complex): 907,49

Chlorophyll b: 885,20

Assay

Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %

E1 cm 1 % 700 at ca 409 nm in chloroform

Description

Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium

Identification

Spectrometry

Maximum in chloroform at ca 409 nm

Purity

Solvent residues

Acetone

Methyl Ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 140 (ii) CHLOROPHYLLINS

Synonyms

CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin

Definition

The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium.

Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

Class

Porphyrin

Colour Index No

75815

Einecs

287-483-3

Chemical names

The major colouring principles in their acid forms are:

3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)

and

3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)

Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.

Magnesium complexes may also be present.

Chemical formula

Chlorophyllin a (acid form): C34H34N4O5

Chlorophyllin b (acid form): C34H32N4O6

Molecular weight

Chlorophyllin a: 578,68

Chlorophyllin b: 592,66

Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

Assay

Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour.

E1 cm 1 % 700 at ca 405 nm in aqueous solution at pH 9

E1 cm 1 % 140 at ca 653 nm in aqueous solution at pH 9

Description

Dark green to blue/black powder

Identification

Spectrometry

Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm

Purity

Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS

Synonyms

CI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin

Definition

Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

Class

Porphyrin

Colour Index No

75815

Einecs

Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5

Chemical names

[Phytyl (132 R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)

[Phytyl (132 R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)

Chemical formula

Copper chlorophyll a: C55H72Cu N4O5

Copper chlorophyll b: C55H70Cu N4O6

Molecular weight

Copper chlorophyll a: 932,75

Copper chlorophyll b: 946,73

Assay

Content of total copper chlorophylls is not less than 10 %.

E1 cm 1 % 540 at ca 422 nm in chloroform

E1 cm 1 % 300 at ca 652 nm in chloroform

Description

Waxy solid ranging in colour from blue green to dark green depending on the source material

Identification

Spectrometry

Maximum in chloroform at ca 422 nm and at ca 652 nm

Purity

Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Copper ions

Not more than 200 mg/kg

Total copper

Not more than 8,0 % of the total copper phaeophytins

E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS

Synonyms

Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5

Definition

The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium.

Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.

Class

Porphyrin

Colour Index No

75815

Einecs

 

Chemical names

The major colouring principles in their acid forms are:

3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a)

and

3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)

Chemical formula

Copper chlorophyllin a (acid form): C34H32Cu N4O5

Copper chlorophyllin b (acid form): C34H30Cu N4O6

Molecular weight

Copper chlorophyllin a: 640,20

Copper chlorophyllin b: 654,18

Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

Assay

Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.

E1 cm 1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5

E1 cm 1 % 145 at ca 630 nm in aqueous phosphate buffer at pH 7,5

Description

Dark green to blue/black powder

Identification

Spectrometry

Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm

Purity

Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Copper ions

Not more than 200 mg/kg

Total copper

Not more than 8,0 % of the total copper chlorophyllins

E 142 GREEN S

Synonyms

CI Food Green 4, Brilliant Green BS

Definition

Green S consists essentially of sodium N-[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.

Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Triarylmethane

Colour Index No

44090

Einecs

221-409-2

Chemical names

Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium;

Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).

Chemical formula

C27H25N2NaO7S2

Molecular Weight

576,63

Assay

Content not less than 80 % total colouring matters calculated as the sodium salt

E1 cm 1 %1 720 at ca 632 nm in aqueous solution

Description

Dark blue or dark green powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 632 nm

B.

Blue or green solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 1,0 %

Organic compounds other than colouring matters:

 

4,4′-bis(dimethylamino)-benzhydryl alcohol

Not more than 0,1 %

4,4′-bis(dimethylamino)-benzophenone

Not more than 0,1 %

3-hydroxynaphthalene-2,7-disulfonic acid

Not more than 0,2 %

Leuco base

Not more than 5,0 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 150a PLAIN CARAMEL

Definition

Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.

Einecs

232-435-9

Description

Dark brown to black liquids or solids

Purity

Colour bound by DEAE cellulose

Not more than 50 %

Colour bound by phosphoryl cellulose

Not more than 50 %

Colour intensity (1)

0,01-0,12

Total nitrogen

Not more than 0,1 %

Total sulphur

Not more than 0,2 %

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 25 mg/kg

E 150b CAUSTIC SULPHITE CARAMEL

Definition

Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.

Einecs

232-435-9

Description

Dark brown to black liquids or solids

Purity

Colour bound by DEAE cellulose

More than 50 %

Colour intensity (1)

0,05-0,13

Total nitrogen

Not more than 0,3 % (2)

Sulphur dioxide

Not more than 0,2 % (2)

Total sulphur

0,3-3,5 % (2)

Sulphur bound by DEAE cellulose

More than 40 %

Absorbance ratio of colour bound by DEAE cellulose

19-34

Absorbance ratio

(A 280/560)

Greater than 50

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 25 mg/kg

E 150c AMMONIA CARAMEL

Definition

Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.

Einecs

232-435-9

Description

Dark brown to black liquids or solids

Purity

Colour bound by DEAE cellulose

Not more than 50 %

Colour bound by phosphoryl cellulose

More than 50 %

Colour intensity (1)

0,08-0,36

Ammoniacal nitrogen

Not more than 0,3 % (2)

4-methylimidazole

Not more than 250 mg/kg (2)

2-acetyl-4-tetrahydroxy-butylimidazole

Not more than 10 mg/kg (2)

Total sulphur

Not more than 0,2 % (2)

Total nitrogen

0,7-3,3 % (2)

Absorbance ratio of colour bound by phosphoryl cellulose

13-35

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 25 mg/kg

E 150d SULPHITE AMMONIA CARAMEL

Definition

Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).

Einecs

232-435-9

Description

Dark brown to black liquids or solids

Purity

Colour bound by DEAE cellulose

More than 50 %

Colour intensity (1)

0,10-0,60

Ammoniacal nitrogen

Not more than 0,6 % (2)

Sulphur dioxide

Not more than 0,2 % (2)

4-methylimidazole

Not more than 250 mg/kg (2)

Total nitrogen

0,3-1,7 % (2)

Total sulphur

0,8-2,5 % (2)

Nitrogen/sulphur ratio of alcohol precipitate

0,7-2,7

Absorbance ratio of alcohol precipitate (3)

8-14

Absorbance ratio (A 280/560)

Not more than 50

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 25 mg/kg

E 151 BRILLIANT BLACK BN, BLACK PN

Synonyms

CI Food Black 1

Definition

Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Bisazo

Colour Index No

28440

Einecs

219-746-5

Chemical names

Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate

Chemical formula

C28H17N5Na4O14S4

Molecular weight

867,69

Assay

Content not less than 80 % total colouring matters calculated as the sodium salt

E1 cm 1 % 530 at ca 570 nm in solution

Description

Black powder or granules

Identification

A.

Spectrometry

Maximum in water at ca 570 nm

B.

Black-bluish solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 10 % (expressed on the dye content)

Organic compounds other than colouring matters:

 

 

4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid

 

4-amino-5-hydroxynaphthalene-1,7-disulfonic acid

 

8-aminonaphthalene-2-sulfonic acid

 

4,4′-diazoaminodi-(benzenesulfonic acid)

Total not more than 0,8 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 153 VEGETABLE CARBON

Synonyms

Vegetable black

Definition

Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.

Colour Index No

77266

Einecs

215-609-9

Chemical names

Carbon

Chemical formula

C

Molecular weight

12,01

Assay

Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis

Description

Black powder, odourless and tasteless

Identification

A.

Solubility

Insoluble in water and organic solvents

B.

Burning

When heated to redness it burns slowly without a flame

Purity

Ash (Total)

Not more than 4,0 % (ignition temperature: 625 °C)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

Polyaromatic hydrocarbons

The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1 000 ml of 0,01 M sulphuric acid.

Loss on drying

Not more than 12 % (120 °C, 4 hrs)

Alkali soluble matter

The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

E 154 BROWN FK

Synonyms

CI Food Brown 1

Definition

Brown FK consists essentially of a mixture of:

I

sodium 4-(2,4-diaminophenylazo) benzenesulfonate

II

sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

III

disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

IV

disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

V

disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

VI

trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)

and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.

Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Azo (a mixture of mono-, bis- and trisazo colours)

Einecs

 

Chemical names

A mixture of:

I

sodium 4-(2,4-diaminophenylazo) benzenesulfonate

II

sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

III

disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

IV

disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

V

disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

VI

trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)

Chemical formula

I

C12H11N4NaO3S

II

C13H13N4NaO3S

III

C18H14N6Na2O6S2

IV

C18H14N6Na2O6S2

V

C19H16N6Na2O6S2

VI

C24H17N8Na3O9S3

Molecular weight

I

314,30

II

328,33

III

520,46

IV

520,46

V

534,47

VI

726,59

Assay

Content not less than 70 % total colouring matters

Of the total colouring matters present the proportions of the components shall not exceed:

I

26 %

II

17 %

III

17 %

IV

16 %

V

20 %

VI

16 %

Description

Red-brown powder or granules

Identification

Orange to reddish solution

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 3,5 %

Organic compounds other than colouring matters:

 

4-aminobenzene-1-sulfonic acid

Not more than 0,7 %

m-phenylenediamine and 4-methyl-m-phenylenediamine

Not more than 0,35 %

Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine

Not more than 0,007 % (calculated as aniline)

Ether extractable matter

From a solution of pH 7, not more than 0,2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 155 BROWN HT

Synonyms

CI Food Brown 3

Definition

Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components.

Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.

Class

Bisazo

Colour Index No

20285

Einecs

224-924-0

Chemical names

Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)

Chemical formula

C27H18N4Na2O9S2

Molecular Weight

652,57

Assay

Content not less than 70 % total colouring matters calculated as the sodium salt.

E1 cm 1 % 403 at ca 460 nm in aqueous solution at pH 7

Description

Reddish-brown powder or granules

Identification

A.

Spectrometry

Maximum in water of pH 7 at ca 460 nm

B.

Brown solution in water

 

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 10 % (TLC method)

Organic compounds other than colouring matters:

 

4-aminonaphthalene-1-sulfonic acid

Not more than 0,7 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % in a solution of pH 7

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 160a (i) MIXED CAROTENES

1.   

Plant carotenes

Synonyms

CI Food Orange 5

Definition

Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.

The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (4), dichloromethane and carbon dioxide.

Class

Carotenoid

Colour Index No

75130

Einecs

230-636-6

Chemical formula

Beta-carotene: C40H56

Molecular weight

Beta-carotene: 536,88

Assay

Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats.

E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane

Identification

Spectrometry

Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm

Purity

Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Propan-2-ol

Hexane

Ethanol

Not more than 50 mg/kg, singly or in combination

Dichloromethane: Not more than 10 mg/kg

Lead

Not more than 5 mg/kg

2.   

Algal carotenes

Synonyms

CI Food Orange 5

Definition

Mixed carotenes may also be produced from natural strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.

The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

Class

Carotenoid

Colour Index No

75130

Chemical formula

Beta-Carotene: C40H56

Molecular weight

Beta-Carotene: 536,88

Assay

Content of carotenes (calculated as beta-carotene) is not less than 20 %

E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

Identification

Spectrometry

Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm

Purity

Natural tocopherols in edible oil

Not more than 0,3 %

Lead

Not more than 5 mg/kg

E 160a (ii) BETA-CAROTENE

1.   

Beta-carotene

Synonyms

CI Food Orange 5

Definition

These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.

Class

Carotenoid

Colour Index No

40800

Einecs

230-636-6

Chemical names

Beta-carotene, beta, beta-carotene

Chemical formula

C40H56

Molecular weight

536,88

Assay

Not less than 96 % total colouring matters (expressed as beta-carotene)

E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

Description

Red to brownish-red crystals or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at 453 nm to 456 nm

Purity

Sulfated ash

Not more than 0,2 %

Subsidiary colouring matters

Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

Lead

Not more than 2 mg/kg

2.   

Beta-carotene from Blakeslea trispora

Synonyms

CI Food Orange 5

Definition

Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.

Class

Carotenoid

Colour Index No

40800

Einecs

230-636-6

Chemical names

Beta-carotene, beta,beta-carotene

Chemical formula

C40H56

Molecular weight

536,88

Assay

Not less than 96 % total colouring matters (expressed as beta-carotene)

E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane

Description

Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)

Identification

Spectrometry

Maximum in cyclohexane at 453 nm to 456 nm

Purity

Solvent residues

Ethyl acetate

Ethanol

Not more than 0,8 %, singly or in combination

Isobutyl acetate: Not more than 1,0 %

Isopropyl alcohol: Not more than 0,1 %

Sulfated ash

Not more than 0,2 %

Subsidiary colouring matters

Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

Lead

Not more than 2 mg/kg

Mycotoxins:

Aflatoxin B1

Absent

Trichothecene (T2)

Absent

Ochratoxin

Absent

Zearalenone

Absent

Microbiology:

Moulds

Not more than 100/g

Yeasts

Not more than 100/g

Salmonella

Absent in 25 g

Escherichia coli

Absent in 5 g

E 160b ANNATTO, BIXIN, NORBIXIN

Synonyms

CI Natural Orange 4

Definition

Class

Carotenoid

Colour Index No

75120

Einecs

Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

Chemical names

Bixin

:

6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate

6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

Norbixin

:

9′Cis-6,6′-diapocarotene-6,6′-dioic acid

9′-Trans-6,6′-diapocarotene-6,6′-dioic acid

Chemical formula

Bixin

:

C25H30O4

Norbixin

:

C24H28O4

Molecular weight

Bixin

:

394,51

Norbixin

:

380,48

Description

Reddish-brown powder, suspension or solution

Identification

Spectrometry

Bixin

:

maximum in chloroform at ca 502 nm

Norbixin

:

maximum in dilute KOH solution at ca 482 nm

(i)   

Solvent extracted bixin and norbixin

Definition

Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.

Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.

Bixin and norbixin may contain other materials extracted from the annatto seed.

The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.

The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.

Assay

Content of bixin powders not less than 75 % total carotenoids calculated as bixin.

Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin

Bixin

:

E1 cm 1 %2 870 at ca 502 nm in chloroform

Norbixin

:

E1 cm 1 %2 870 at ca 482 nm in KOH solution

Purity

Solvent residues

Acetone

Methanol

Hexane

not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

(ii)   

Alkali extracted annatto

Definition

Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.)

Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.

Assay

Contains not less than 0,1 % of total carotenoids expressed as norbixin

Norbixin

:

E1 cm 1 %2 870 at ca 482 nm in KOH solution

Purity

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

(iii)   

Oil extracted annatto

Definition

Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present.

Assay

Contains not less than 0,1 % of total carotenoids expressed as bixin

Bixin

:

E1 cm 1 %2 870 at ca 502 nm in chloroform

Purity

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN

Synonyms

Paprika Oleoresin

Definition

Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.

Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide.

Class

Carotenoid

Einecs

Capsanthin: 207-364-1, capsorubin: 207-425-2

Chemical names

Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-one

Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-carotene-6,6′-dione

Chemical formula

Capsanthin: C40H56O3

Capsorubin: C40H56O4

Molecular weight

Capsanthin: 584,85

Capsorubin: 600,85

Assay

Paprika extract: content not less than 7,0 % carotenoids

Capsanthin/capsorubin: not less than 30 % of total carotenoids

E1 cm 1 %2 100 at ca 462 nm in acetone

Description

Dark-red viscous liquid

Identification

A.

Spectrometry

Maximum in acetone at ca 462 nm

B.

Colour reaction

A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform

Purity

Solvent residues

Ethyl acetate

Methanol

Ethanol

Acetone

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Capsaicin

Not more than 250 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 160d LYCOPENE

Synonyms

Natural Yellow 27

Definition

Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.

Class

Carotenoid

Colour Index No

75125

Chemical names

Lycopene, ψ,ψ-carotene

Chemical formula

C40H56

Molecular weight

536,85

Assay

Content not less than 5 % total colouring matters

E1 cm 1 %3 450 at ca 472 nm in hexane

Description

Dark red viscous liquid

Identification

Spectrometry

Maximum in hexane at ca 472 nm

Purity

Solvent residues

Ethyl acetate

Methanol

Ethanol

Acetone

Hexane

Propan-2-ol

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Sulfated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 160e BETA-APO-8′-CAROTENAL (C30)

Synonyms

CI Food Orange 6

Definition

These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotinoid

Colour Index No

40820

Einecs

214-171-6

Chemical names

β-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde

Chemical formula

C30H40O

Molecular weight

416,65

Assay

Not less than 96 % of total colouring matters

E1 cm 1 %2 640 at ca 460-462 nm in cyclohexane

Description

Dark violet crystals with metallic lustre or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at 460-462 nm

Purity

Sulfated ash

Not more than 0,1 %

Subsidiary colouring matters

Carotenoids other than β-apo-8′-carotenal:

not more than 3,0 % of total colouring matters

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)

Synonyms

CI Food Orange 7, β-apo-8′-carotenoic ester

Definition

These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotenoid

Colour Index No

40825

Einecs

214-173-7

Chemical names

β-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate

Chemical formula

C32H44O2

Molecular weight

460,70

Assay

Not less than 96 % of total colouring matters

E1 cm 1 %2 550 at ca 449 nm in cyclohexane

Description

Red to violet-red crystals or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at ca 449 nm

Purity

Sulfated ash

Not more than 0,1 %

Subsidiary colouring matters

Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 161b LUTEIN

Synonyms

Mixed Carotenoids, Xanthophylls

Definition

Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.

Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide

Class

Carotenoid

Einecs

204-840-0

Chemical names

3,3′-dihydroxy-d-carotene

Chemical formula

C40H56O2

Molecular weight

568,88

Assay

Content of total colouring matter not less than 4 % calculated as lutein

E1 cm 1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)

Description

Dark, yellowish brown liquid

Identification

Spectrometry

Maximum in chloroform/ethanol (10 + 90) at ca 445 nm

Purity

Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination

Dichloromethane: not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 161g CANTHAXANTHIN

Synonyms

CI Food Orange 8

Definition

These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotinoid

Colour Index No

40850

Einecs

208-187-2

Chemical names

β-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene

Chemical formula

C40H52O2

Molecular weight

564,86

Assay

Not less than 96 % of total colouring matters (expressed as canthaxanthin)

E1 cm 1 %2 200

at ca 485 nm in chloroform

at 468-472 nm in cyclohexane

at 464-467 nm in petroleum ether

Description

Deep violet crystals or crystalline powder

Identification

Spectrometry

Maximum in chloroform at ca 485 nm

Maximum in cyclohexane at 468-472 nm

Maximum in petroleum ether at 464-467 nm

Purity

Sulfated ash

Not more than 0,1 %

Subsidiary colouring matters

Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 162 BEETROOT RED, BETANIN

Synonyms

Beet Red

Definition

Beet red is obtained from the roots of natural strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.

Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.

Class

Betalaine

Einecs

231-628-5

Chemical names

(S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate

Chemical formula

Betanin: C24H26N2O13

Molecular weight

550,48

Assay

Content of red colour (expressed as betanine) is not less than 0,4 %

E1 cm 1 %1 120 at ca 535 nm in aqueous solution at pH 5

Description

Red or dark red liquid, paste, powder or solid

Identification

Spectrometry

Maximum in water of pH 5 at ca 535 nm

Purity

Nitrate

Not more than 2 g nitrate anion/g of red colour (as calculated from assay).

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 163 ANTHOCYANINS

Definition

Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material.

Class

Anthocyanin

Einecs

208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)

Chemical names

3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)

3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)

3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)

3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)

3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)

3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)

Chemical formula

Cyanidin: C15H11O6Cl

Peonidin: C16H13O6Cl

Malvidin: C17H15O7Cl

Delphinidin: C15H11O7Cl

Petunidin: C16H13O7Cl

Pelargonidin: C15H11O5Cl

Molecular weight

Cyanidin: 322,6

Peonidin: 336,7

Malvidin: 366,7

Delphinidin: 340,6

Petunidin: 352,7

Pelargonidin: 306,7

Assay

E1 cm 1 % 300 for the pure pigment at 515-535 nm at pH 3,0

Description

Purplish-red liquid, powder or paste, having a slight characteristic odour

Identification

Spectrometry

Maximum in methanol with 0,01 % conc. HCl

Cyanidin: 535 nm

Peonidin: 532 nm

Malvidin: 542 nm

Delphinidin: 546 nm

Petunidin: 543 nm

Pelargonidin: 530 nm

Purity

Solvent residues

Methanol

Ethanol

Not more than 50 mg/kg, singly or in combination

Sulfur dioxide

Not more than 1 000 mg/kg per percent pigment

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 170 CALCIUM CARBONATE

Synonyms

CI Pigment White 18, Chalk

Definition

Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.

Class

Inorganic

Colour Index No

77220

Einecs

Calcium carbonate: 207-439-9

Limestone: 215-279-6

Chemical names

Calcium carbonate

Chemical formula

CaCO3

Molecular weight

100,1

Assay

Content not less than 98 % on the anhydrous basis

Description

White crystalline or amorphous, odourless and tasteless powder

Identification

Solubility

Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.

Purity

Loss on drying

Not more than 2,0 % (200 °C, 4 hours)

Acid-insoluble substances

Not more than 0,2 %

Magnesium and alkali salts

Not more than 1,5 %

Fluoride

Not more than 50 mg/kg

Antimony (as Sb)

Copper (as Cu)

Chromium (as Cr)

Zinc (as Zn)

Barium (as Ba)

Not more than 100 mg/kg, singly or in combination

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Cadmium

Not more than 1 mg/kg

E 171 TITANIUM DIOXIDE

Synonyms

CI Pigment White 6

Definition

Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.

Class

Inorganic

Colour Index No

77891

Einecs

236-675-5

Chemical names

Titanium dioxide

Chemical formula

TiO2

Molecular weight

79,88

Assay

Content not less than 99 % on an alumina and silica-free basis

Description

White to slightly coloured powder

Identification

Solubility

Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.

Purity

Loss on drying

Not more than 0,5 % (105 °C, 3 hours)

Loss on ignition

Not more than 1,0 % on a volatile matter free basis (800 °C)

Aluminium oxide and/or silicon dioxide

Total not more than 2,0 %

Matter soluble in 0,5 N HCl

Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.

Water soluble matter

Not more than 0,5 %

Cadmium

Not more than 1 mg/kg

Antimony

Not more than 50 mg/kg by total dissolution

Arsenic

Not more than 3 mg/kg by total dissolution

Lead

Not more than 10 mg/kg by total dissolution

Mercury

Not more than 1 mg/kg by total dissolution

Zink

Not more than 50 mg/kg by total dissolution

E 172 IRON OXIDES AND IRON HYDROXIDES

Synonyms

Iron Oxide Yellow

:

CI Pigment Yellow 42 and 43

Iron Oxide Red

:

CI Pigment Red 101 and 102

Iron Oxide Black

:

CI Pigment Black 11

Definition

Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.

Class

Inorganic

Colour Index No

Iron Oxide Yellow

:

77492

Iron Oxide Red

:

77491

Iron Oxide Black

:

77499

Einecs

Iron Oxide Yellow

:

257-098-5

Iron Oxide Red

:

215-168-2

Iron Oxide Black

:

235-442-5

Chemical names

Iron Oxide Yellow

:

hydrated ferric oxide, hydrated iron (III) oxide

Iron Oxide Red

:

anhydrous ferric oxide, anhydrous iron (III) oxide

Iron Oxide Black

:

ferroso ferric oxide, iron (II, III) oxide

Chemical formula

Iron Oxide Yellow

:

FeO(OH)·H2O

Iron Oxide Red

:

Fe2O3

Iron Oxide Black

:

FeO·Fe2O3

Molecular weight

88,85

:

FeO(OH)

159,70

:

Fe2O3

231,55

:

FeO·Fe2O3

Assay

Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron

Description

Powder; yellow, red, brown or black in hue

Identification

Solubility

Insoluble in water and in organic solvents

Soluble in concentrated mineral acids

Purity

Water soluble matter

Not more than 1,0 %

By total dissolution

Arsenic

Not more than 5 mg/kg

Barium

Not more than 50 mg/kg

Cadmium

Not more than 5 mg/kg

Chromium

Not more than 100 mg/kg

Copper

Not more than 50 mg/kg

Lead

Not more than 20 mg/kg

Mercury

Not more than 1 mg/kg

Nickel

Not more than 200 mg/kg

Zinc

Not more than 100 mg/kg

E 173 ALUMINIUM

Synonyms

CI Pigment Metal, Al

Definition

Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.

Colour Index No

77000

Einecs

231-072-3

Chemical names

Aluminium

Chemical formula

Al

Atomic weight

26,98

Assay

Not less than 99 % calculated as Al on an oil-free basis

Description

A silvery-grey powder or tiny sheets

Identification

Solubility

Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.

Purity

Loss on drying

Not more than 0,5 % (105 °C, to constant weight)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg

E 174 SILVER

Synonyms

Argentum, Ag

Class

Inorganic

Colour Index No

77820

Einecs

231-131-3

Chemical names

Silver

Chemical formula

Ag

Atomic weight

107,87

Assay

Content not less than 99,5 % Ag

Description

Silver-coloured powder or tiny sheets

E 175 GOLD

Synonyms

Pigment Metal 3, Aurum, Au

Class

Inorganic

Colour Index No

77480

Einecs

231-165-9

Chemical names

Gold

Chemical formula

Au

Atomic weight

197,0

Assay

Content not less than 90 % Au

Description

Gold-coloured powder or tiny sheets

Purity

Silver

Not more than 7,0 %

After complete dissolution

Copper

Not more than 4,0 %

E 180 LITHOLRUBINE BK

Synonyms

CI Pigment Red 57, Rubinpigment, Carmine 6B

Definition

Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components.

Class

Monoazo

Colour Index No

15850:1

Einecs

226-109-5

Chemical names

Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate

Chemical formula

C18H12CaN2O6S

Molecular weight

424,45

Assay

Content not less than 90 % total colouring matters

E1 cm 1 % 200 at ca 442 nm in dimethylformamide

Description

Red powder

Identification

Spectrometry

Maximum in dimethylformamide at ca 442 nm

Purity

Subsidiary colouring matters

Not more than 0,5 %

Organic compounds other than colouring matters:

 

2-Amino-5-methylbenzenesulfonic acid, calcium salt

Not more than 0,2 %

3-hydroxy-2-naphthalenecarboxylic acid, calcium salt

Not more than 0,4 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (expressed as aniline)

Ether extractable matter

From a solution of pH 7, not more than 0,2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 40 mg/kg


(1)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

(2)  Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

(3)  Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).

(4)  Benzene not more than 0,05 % v/v.


ANNEX II

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

Commission Directive 95/45/EC

(OJ L 226, 22.9.1995, p. 1)

Commission Directive 1999/75/EC

(OJ L 206, 5.8.1999, p. 19)

Commission Directive 2001/50/EC

(OJ L 190, 12.7.2001, p. 14)

Commission Directive 2004/47/EC

(OJ L 113, 20.4.2004, p. 24)

Commission Directive 2006/33/EC

(OJ L 82, 21.3.2006, p. 10)

PART B

List of time-limits for transposition into national law

(referred to in Article 2)

Directive

Time-limit for transposition

95/45/EC

1 July 1996 (1)

1999/75/EC

1 July 2000

2001/50/EC

29 June 2002

2004/47/EC

1 April 2005 (2)

2006/33/EC

10 April 2007


(1)  According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted.

(2)  According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted.


ANNEX III

Correlation table

Directive 95/45/EC

This Directive

Article 1, first paragraph

Article 1

Article 1, second paragraph

Article 2

Article 2

Article 3

Article 3

Article 4

Article 4

Annex

Annex I

Annex II

Annex III


II Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory

DECISIONS

Commission

10.1.2009   

EN

Official Journal of the European Union

L 6/64


COMMISSION DECISION

of 2 December 2008

establishing a major accident report form pursuant to Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances

(notified under document number C(2008) 7530)

(Text with EEA relevance)

(2009/10/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (1), and in particular Article 15(2) thereof,

After consulting the Committee established by Article 22 of the Directive,

Whereas:

(1)

Article 14 of Directive 96/82/EC requires the Member States to ensure that, as soon as practicable following a major accident, the operator shall be required to inform the competent authorities. Article 15(1) of the Directive requires the Member States to inform the Commission as soon as practicable of major accidents within their territory meeting the criteria of Annex VI to the Directive. Article 15(2) of the Directive provides that the Member States shall, as soon as the information pursuant to Article 14 has been collected, inform the Commission of their analysis of the accident and recommendations on future preventive measures.

(2)

The information required pursuant to Article 15(2) has to be provided using a report form established and kept under review in accordance with the procedure referred to in Article 22 of the Directive.

(3)

The measures envisaged in this Decision are in accordance with the opinion of the Committee established by Article 22 of the Directive,

HAS ADOPTED THIS DECISION:

Article 1

For the purposes of Article 15(2) of Directive 96/82/EC on the control of major-accident hazards involving dangerous substances, the major accident report form set out in the Annex to this Decision is hereby adopted.

Article 2

With effect from 1 December 2008, the Member States shall provide reports containing information in accordance with the Annex, using the register and information system pursuant to Article 19(2) of Directive 96/82/EC.

Article 3

The definitive application of the major accident report form set out in the Annex shall be preceded by a test phase of 5 months, starting on 1 December 2008.

Article 4

If the test phase shows the necessity to amend the major accident report form set out in the Annex, the present Decision shall be amended in accordance with the procedure laid down in Article 22 of the Directive.

Article 5

Confidential information shall be handled in accordance with Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal rules of procedures (2).

Article 6

Member States’ reports shall only contain the information available to the competent authorities.

Article 7

This Decision is addressed to the Member States.

Done at Brussels, 2 December 2008.

For the Commission

Stavros DIMAS

Member of the Commission


(1)  OJ L 10, 14.1.1997, p. 13.

(2)  OJ L 317, 3.12.2001, p. 1.


ANNEX

Information to be provided in accordance with Article 15(2) of Directive 96/82/EC

(Where reference is made to the register and information system, this is the Commission’s Major Accident Reporting System electronic database, available at http://mahbsrv.jrc.it)

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10.1.2009   

EN

Official Journal of the European Union

L 6/79


COMMISSION DECISION

of 19 December 2008

authorising methods for grading pig carcases in Spain

(notified under document number C(2008) 8477)

(Only the Spanish text is authentic)

(2009/11/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 3220/84 of 13 November 1984 determining the Community scale for grading pig carcases (1), and in particular Article 5(2) thereof,

Whereas:

(1)

Under Article 2(3) of Regulation (EEC) No 3220/84, the grading of pig carcases is to be determined by estimating the lean meat content by means of statistically proven assessment methods based on the physical measurement of one or more anatomical parts of the pig carcase. The authorisation of grading methods is subject to compliance with a maximum tolerance for statistical error in assessment. This tolerance is defined in Article 3(2) of Commission Regulation (EEC) No 2967/85 of 24 October 1985 laying down detailed rules for the application of the Community scale for grading pig carcases (2).

(2)

Commission Decision 88/479/EEC (3) authorises four methods (DEST, FOM, HGP and Autofom) for grading pig carcases in Spain.

(3)

Due to technical adaptations, Spain has asked the Commission to authorise the update of two methods (FOM and Autofom), the utilisation of two new methods (Ultrafom 300 and VCS2000) and the repeal of two methods (HGP and DEST), and has presented the results of its dissection trials in the second part of the protocol provided for in Article 3(3) of Regulation (EEC) No 2967/85.

(4)

Examination of this request has revealed that the conditions for authorising these grading methods are fulfilled.

(5)

In accordance with the second subparagraph of Article 2(1) of Regulation (EEC) No 3220/84 Member States may be authorised to provide for a presentation of pig carcases different from the one specified in that Article where commercial practice or technical requirements warrant such a derogation. In Spain, commercial practice may require also the removal of the forefeet from the pig carcases, in addition to the removal of the tongue, bristles, hooves, genital organs, fare flat, kidneys and diaphragm as required by Article 2(1) of Regulation (EEC) No 3220/84.

(6)

No modification of the apparatus or grading methods may be authorised except by means of a new Commission Decision adopted in the light of experience gained. For this reason, the present authorisation may be revoked.

(7)

For the sake of clarity, Decision 88/479/EEC should be repealed and replaced by a new Decision.

(8)

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

HAS ADOPTED THIS DECISION:

Article 1

The use of the following methods is hereby authorised for grading pig carcases pursuant to Regulation (EEC) No 3220/84 in Spain:

(a)

the apparatus termed ‘Fat-O-Meater (FOM)’ and assessment methods related thereto, details of which are given in Part 1 of the Annex;

(b)

the apparatus termed ‘Fully automatic ultrasonic carcase grading (Autofom)’ and assessment methods related thereto, details of which are given in Part 2 of the Annex;

(c)

the apparatus termed ‘Ultrafom 300’ and assessment methods related thereto, details of which are given in Part 3 of the Annex;

(d)

the apparatus termed ‘Automatic vision system (VCS2000)’ and assessment methods related thereto, details of which are given in Part 4 of the Annex.

Article 2

By way of derogation from Article 2 of Regulation (EEC) No 3220/84, pig carcases may be presented also without forefeet before being weighed and graded. In this case, in order to establish quotations for pig carcases on a comparable basis, the recorded hot weight shall be increased by 0,840 kilograms.

Article 3

Modifications of the apparatus or the assessment methods shall not be authorised.

Article 4

Decision 88/479/EEC is repealed.

Article 5

This Decision is addressed to the Kingdom of Spain.

Done at Brussels, 19 December 2008.

For the Commission

Mariann FISCHER BOEL

Member of the Commission


(1)  OJ L 301, 20.11.1984, p. 1.

(2)  OJ L 285, 25.10.1985, p. 39.

(3)  OJ L 234, 24.8.1988, p. 20.


ANNEX

METHODS FOR GRADING PIG CARCASES IN SPAIN

Part 1

FAT-O-MEATER (FOM)

1.

Grading of pig carcases shall be carried out by means of the apparatus termed ‘Fat-O-Meater (FOM)’.

2.

The apparatus shall be equipped with a probe of 6-millimetre diameter containing a photodiode of the Siemens SFH 950 type and a photodetector (type SFH 960), having an operating distance of between 3 and 103 millimetres. The results of the measurements are converted into estimated lean meat content by means of a computer.

3.

The lean meat content of the carcase shall be calculated according to the following formula:

Image = 66,91 – 0,895 X1 + 0,144 X2

where:

Image

=

the estimated lean meat content (in percentage),

X1

=

the thickness of the fat between the third and fourth last rib at 60 mm of the midline of the carcase (in millimetres),

X2

=

the thickness of muscle measured at the same time and in the same place as X1 (in millimetres).

This formula shall be valid for carcases weighing between 60 and 120 kilograms.

Part 2

FULLY AUTOMATIC ULTRASONIC CARCASE GRADING (AUTOFOM)

1.

Pig carcase grading shall be carried out using the apparatus termed ‘Fully automatic ultrasonic carcase grading (Autofom)’.

2.

The apparatus shall be equipped with sixteen 2 MHz ultrasonic transducers (Krautkrämer, SFK 2 NP), with an operating distance between transducers of 25 mm.

The ultrasonic data shall comprise measurements of back fat thickness and muscle thickness.

The results of the measurements are converted into estimated lean meat content using a computer.

3.

The carcase’s lean meat content shall be calculated on the basis of 34 measurement points using the following formula:

Image = 70,59614 – 0,0904 · V22 – 0,23033 · V23 – 0,15558 · V44 + 0,086638 · V46 – 0,09965 · V48 – 0,10002 · V49 – 0,11624 · V51 – 0,05561 · V52 – 0,04854 · V53 – 0,0432 · V54 – 0,00282 · V55 + 0,051829 · V57 + 0,036795 · V58 – 0,00519 · V59 – 0,0269 · V60 – 0,06432 · V61 – 0,05323 · V62 – 0,05229 · V64 – 0,0523 · V65 + 0,005645 · V72 – 0,06505 · V73 – 0,04587 · V74 + 0,015041 · V77 + 0,030928 · V78 – 0,08024 · V79 – 0,07275 · V80 – 0,07497 · V85 – 0,06818 · V86 – 0,06875 · V87 – 0,04742 · V90 – 0,00698 · V91 + 0,046485 · V92 – 0,10403 · V93 + 0,160475 · V123

where:

Image

=

the estimated lean meat content of the carcase,

V22, V23, … V123 are the variables measured with the Autofom.

4.

Descriptions of the measurement points and the statistical method can be found in Part II of the Spanish protocol forwarded to the Commission in accordance with Article 3(3) of Regulation (EEC) No 2967/85.

This formula shall be valid for carcases weighing between 60 and 120 kilograms.

Part 3

ULTRAFOM 300

1.

Grading of pig carcases shall be carried out by means of the apparatus termed ‘Ultrafom 300’.

2.

The apparatus shall be equipped with an ultrasonic probe at 4 MHz (Krautkrämer MB 4 SE). The ultrasonic signal is digitised, stored and processed by a microprocessor (type Intel 80 C 32). The results of the measurements shall be converted into estimated lean meat content by means of the Ultrafom apparatus itself.

3.

The lean meat content of the carcase shall be calculated according to the following formula:

Image = 69,22 – 1,023 X1 + 0,116 X2

where:

Image

=

the estimated lean meat content (in percentage),

X1

=

the thickness of the fat between the third and fourth last rib at 70 mm of the midline of the carcase (in millimetres),

X2

=

the thickness of muscle measured at the same time and in the same place as X1 (in millimetres).

This formula shall be valid for carcases weighing between 60 and 120 kilograms.

Part 4

AUTOMATIC VISION SYSTEM (VCS2000)

1.

Grading of pig carcases is carried out by means of the apparatus termed ‘Automatic vision system (VCS2000)’.

2.

The apparatus VCS 2000 is a picture-processing system for automatically determining the trade values of pork carcase halves. The system is used online within the slaughtering production system where via a camera system the carcase halves are automatically filmed. The picture data is then processed in a computer by special picture processing software.

3.

The lean meat content of the carcases shall be calculated on the basis of 70 measurement points according to the following formula:

Image = 37,49855 + 0,017715 · X2 – 0,00075 · X40 – 0,02522 · X50 – 0,04549 · X52 – 0,0000335 · X59 – 0,000093 · X62 – 0,0000814 · X63 – 0,0000715 · X64 – 0,0000494 · X66 – 0,0000482 · X67 – 0,00047 · X69 + 0,000304 · X70 + 0,00867 · X77 – 0,03007 · X79 – 0,04575 · X81 – 0,01742 · X82 – 0,01768 · X83 – 0,03114 · X84 – 0,02549 · X85 – 0,0265 · X92 – 0,03299 · X95 – 0,02472 · X99 – 0,0399 · X102 + 0,020178 · X103 – 0,04614 · X106 + 0,012659 · X107 + 0,012256 · X110 + 0,015358 · X113 – 0,23294 · X116 + 0,010157 · X117 – 0,07282 · X120 + 0,126624 · X142 + 6,052785 · X2/6 – 13,2893 · X14/10 + 7,287408 · X77/51 – 4,09296 · X79/51 – 11,4326 · X81/51 – 1,28847 · X82/51 – 0,57019 · X83/51 – 5,21869 · X84/51 – 2,92106 · X85/51 + 8,274608 · X88/51 + 9,886478 · X91/51 – 0,00442 · X47/79 – 0,04848 · X50/79 + 0,227913 · X54/79 + 2,845209 · X77/79 + 0,018409 · X86/79 – 0,00838 · X89/79 + 0,007447 · X94/79 + 136,5994 · X27/20 + 182,973 · X29/20 – 6,82665 · X59/20 – 261 768 · X61/20 – 7,85416 · X62/20 – 3,8587 · X63/20 – 16,6166 · X64/20 – 59,2087 · X65/20 – 3,21138 · X66/20 – 6,96096 · X67/20 + 20,91982 · X68/20 – 109,736 · X69/20 + 243,641 · X70/20 + 29,84246 · X73/20 + 15,50442 · X74/20 – 0,30367 · X36/59 – 2,07787 · X40/59 – 0,38605 · X42/59 – 1,90547 · X69/59 + 3,554836 · X70/59

where:

Image

=

the estimated percentage of lean meat in the carcase,

X2, X40, … X70/59 are the variables measured with the VCS2000.

4.

Descriptions of the measurement points and the statistical method can be found in Part II of the Spanish protocol forwarded to the Commission in accordance with Article 3(3) of Regulation (EEC) No 2967/85.

This formula shall be valid for carcases weighing between 60 and 120 kilograms.


10.1.2009   

EN

Official Journal of the European Union

L 6/83


COMMISSION DECISION

of 19 December 2008

authorising methods for grading pig carcases in Denmark

(notified under document number C(2008) 8498)

(Only the Danish text is authentic)

(2009/12/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 3220/84 of 13 November 1984 determining the Community scale for grading pig carcases (1), and in particular Article 5(2) thereof,

Whereas:

(1)

Under Article 2(3) of Regulation (EEC) No 3220/84, the grading of pig carcases is to be determined by estimating the lean-meat content by means of statistically proven assessment methods based on the physical measurement of one or more anatomical parts of the pig carcase. The authorisation of grading methods is subject to compliance with a maximum tolerance for statistical error in assessment. This tolerance is defined in Article 3(2) of Commission Regulation (EEC) No 2967/85 of 24 October 1985 laying down detailed rules for the application of the Community scale for grading pig carcases (2).

(2)

Commission Decision 92/469/EEC (3) authorises four methods for grading pig carcases in Denmark.

(3)

Due to technical adaptations, Denmark has asked the Commission to authorise the update of four authorised methods and the utilisation of two updated methods (Autofom DK and FOM II), and has presented the results of its dissection trials in the second part of the protocol provided for in Article 3(3) of Regulation (EEC) No 2967/85.

(4)

Examination of this request has revealed that the conditions for authorising these grading methods are fulfilled.

(5)

No modification of the apparata or grading methods may be authorised except by means of a new Commission Decision adopted in the light of experience gained. For this reason, the present authorisation may be revoked.

(6)

For the sake of clarity, Decision 92/469/EEC should be repealed and replaced by a new decision.

(7)

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

HAS ADOPTED THIS DECISION:

Article 1

The use of the following methods is hereby authorized for grading pig carcases pursuant to Regulation (EEC) No 3220/84 in Denmark:

(a)

the apparatus termed ‘Klassificeringscenter (KC)’ and assessment methods related thereto, details of which are given in Part 1 of the Annex;

(b)

the apparatus termed ‘Fat-O-Meater/Manuel Klassificering (FOM/MK)’ and assessment methods related thereto, details of which are given in Part 2 of the Annex;

(c)

the apparatus termed ‘Uni-Fat-O-Meater (Unifom)’ and assessment methods related thereto, details of which are given in Part 3 of the Annex;

(d)

the apparatus termed ‘Fully automatic ultrasonic equipment (AutoFOM 1)’ and assessment methods related thereto, details of which are given in Part 4 of the Annex;

(e)

the apparatus termed ‘Updated fully automatic ultrasonic equipment (AutoFOM DK)’ and assessment methods related thereto, details of which are given in Part 5 of the Annex;

(f)

the apparatus termed ‘Fat-O-Meater II (FOM II)’ and assessment methods related thereto, details of which are given in Part 6 of the Annex.

Article 2

Modifications of the apparata or the assessment methods shall not be authorised.

Article 3

Decision 92/469/EEC is hereby repealed.

Article 4

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 19 December 2008.

For the Commission

Mariann FISCHER BOEL

Member of the Commission


(1)  OJ L 301, 20.11.1984, p. 1.

(2)  OJ L 285, 25.10.1985, p. 39.

(3)  OJ L 265, 11.9.1992, p. 39.


ANNEX

METHODS FOR GRADING PIG CARCASES IN DENMARK

Part 1

KLASSIFICERINGSCENTER (KC)

1.

Grading of pig carcases shall be carried out by means of the apparatus termed ‘Klassificeringscenter (KC)’.

2.

The apparatus shall be equipped with nine probes of six millimetres each containing a photodiode (Siemens of the type SFH 950 LD242 II or similar) and a photodetector (Siemens of the type SFH 960 — PB 103 or similar) and having an operation distance of between one and 180 millimetres. The results of the measurements are converted into estimated lean meat content by means of a central unit.

3.

The lean meat content of the carcase shall be calculated on the basis of 10 measurements taken from seven measuring-points as are indicated in paragraph 4 and according to the following formula

Image = 70,5489 – 0,1572 x1 – 0,1698 x2 – 0,1537 x3 – 0,1803 x4 – 0,2115 x5 – 0,1669 x6 – 0,1269 x7 + 0,04278 x8 + 0,0234 x9 + 0,0371 x10

where:

Image

=

the estimated percentage of lean meat in carcase.

4.

The measurement points are:

x1

=

the thickness of backfat (including rind) in millimetres, measured at the centre of the third cervical vertebra, at 10,5 cm off the midline of the carcase.

x2

=

the thickness of backfat (including rind) in millimetres, measured at the centre of fourth cervical vertebra, at 7 cm off the midline of the carcase.

x3

=

the thickness of backfat (including rind) in millimetres, measured between fourth and fifth hindmost thoracic vertebra, at 3 cm off the midline of the carcase.

x4

=

the thickness of backfat (including rind) in millimetres, measured between second and third hindmost thoracic vertebra, at 7 cm off the midline of the carcase.

x5

=

the thickness of backfat (including rind) in millimetres, measured between first lumbar vertebra and last thoracic vertebra, at 6 cm off the midline of the carcase.

x6

=

the thickness of backfat (including rind) in millimetres, measured 4 cm before the fore edge of the pubic bone, at 7 cm off the midline of the carcase.

x7

=

the thickness of backfat (including rind) in millimetres, measured at the fore edge of the pubic bone, at 11 cm off the midline of the carcase.

x8

=

muscle thickness in millimetres, measured between fourth and fifth hindmost thoracic vertebra, at 3 cm off the midline of the carcase.

x9

=

muscle thickness in millimetres, measured between second and third hindmost thoracic vertebra, at 7 cm off the midline of the carcase.

x10

=

muscle thickness in millimetres, measured between first lumbar vertebra and hindmost thoracic vertebra, at 6 cm off the midline of the carcase.

The formulae shall be valid for carcases weighing between 50 and 110 kg.

Part 2

FAT-O-MEATER/MANUEL KLASSIFICERING (FOM/MK)

1.

Pig carcase grading shall be carried out using the apparatus termed ‘Fat-O-Meater/Manuel Klassificering (FOM/MK)’.

2.

The apparatus is a Fat-O-Meater type of equipment and it shall be equipped with a probe of six millimetres diameter containing a photodetector (Siemens of the type SFH 960 — BP 103 or similar) and having an operation distance of between one and 94 millimetres.

3.

The results of the measurements are converted into estimated lean meat content by means of a central unit.

The lean meat content of the carcase shall be calculated according to the following formula

Image = 68,1746 – 0,3220 x1 – 0,5326 x2 + 0,0836 x3

where:

Image

=

the estimated percentage of lean meat in carcase.

4.

The measurement points are:

x1

=

the thickness of backfat (including rind) in millimetres, measured at 8 cm off the midline of the carcase between the third and fourth last lumbar vertebrae.

x2

=

the thickness of backfat (including rind) in millimetres, measured at 6 cm off the midline of the carcase between the third and fourth last ribs.

x3

=

the thickness of muscle in millimetres, measured at the same time and in the same place as x2.

The formulae shall be valid for carcases weighing between 50 and 110 kg.

Part 3

UNI-FAT-O-MEATER (UNIFOM)

1.

Grading of pig carcases shall be carried out by means of the apparatus termed ‘Uni-Fat-O-Meater’ (Unifom).

2.

The apparatus is the same as the apparatus described under point 2 of part 2. However, Unifom differs from MK with regard to computer and software for the interpretation of the reflection profile from the optical probe.

3.

The lean meat content of the carcase shall be calculated according to the following formula

Image = 66,7393 – 0,2655 x1 – 0,5432 x2 + 0,0838 x3

where:

Image

=

the estimated percentage of lean meat in carcase.

4.

The measurement points are:

x1

=

the thickness of backfat (including rind) in millimetres, measured at 8 cm off the midline of the carcase between the third and fourth last lumbar vertebrae.

x2

=

the thickness of backfat (including rind) in millimetres, measured at 6 cm off the midline of the carcase between the third and fourth last ribs.

x3

=

the thickness of muscle in millimetres, measured at the same time and in the same place as x2.

The formulae shall be valid for carcases weighing between 50 and 110 kg.

Part 4

FULLY AUTOMATIC ULTRASONIC EQUIPMENT (AutoFOM 1)

1.

Grading of the pig carcases shall be carried out by means of the apparatus termed ‘Fully automatic ultrasonic equipment (AutoFOM 1)’.

2.

The apparatus shall be equipped with 16 ultrasonic transducers, 2MHz (Krautkrämer, SFK 2 NP or similar) with a distance of 25 mm between each transducer.

The results of the measurements are converted into estimated lean mean content by means of a central data-processing unit.

3.

The lean meat content of the carcase shall be calculated on the basis of 127 individual measuring points according to the following formula

Image = c + c0 × IP000 + c1 × IP001 + .... + c126 × IP126

where:

Image

=

the estimated percentage of lean meat in carcase. The constants c and c0 up to c126 appear from the Danish Protocol, Part II, submitted to the Commission under the terms of Article 3(3) of Commission Regulation (EEC) No 2967/85.

4.

The description of the measurement points and the description of the statistical method are laid down in the Danish Protocol, Part II, submitted to the Commission under the terms of Article 3(3) of Commission Regulation (EEC) No 2967/85.

The formula shall be valid for carcases weighing between 50 and 110 kg.

Part 5

UPDATED FULLY AUTOMATIC ULTRASONIC EQUIPMENT (AutoFOM DK)

1.

Grading of pig carcase shall be carried out by means of the apparatus termed ‘Updated fully automatic ultrasonic equipment (AutoFOM DK)’.

2.

The apparatus is mechanically compatible with the AutoFOM 1 concerning the scanner array itself. Likewise, the measuring principle itself remains unchanged. AutoFOM DK differs from AutoFOM 1 with regard to a fixture which ensures that the carcase passes the measuring unit in a straight position, and which together with a laser sensor detecting the carcase, provides symmetric measurements, with more computation power and a new software packages providing the opportunity to enhance the imaging speed and resolution.

3.

The lean meat content of carcase shall be calculated according to the following formula:

Image = 63,4322 – 0,1429 x1 – 0,0438 x2 – 0,0715 x3 + 0,9420 x4 + 0,0911 x5

where:

Image

=

the estimated percentage of lean meat in carcase.

4.

The description of the measurement points and the description of the statistical method are laid down in the Danish Protocol, Part II, submitted to the Commission under the terms of Article 3(3) of Commission Regulation (EEC) No 2967/85.

The formula shall be valid for carcases weighing between 50 and 110 kg.

Part 6

FAT-O-MEATER II (FOM II)

1.

Grading of pig carcase shall be carried out by means of the apparatus termed ‘Fat-O-Meater II (FOM II)’.

2.

The apparatus is a new version of the FAT-O-Meater measurement system. The basic measurement principle, as described in point 2 in Part 2 and 3, is unchanged, but all software, hardware as well as the mechanical design is redesigned. The FOM II pistol consists of an optical probe with a knife, a depth measurement device and a data acquisition and analysis board. All legally relevant acquisition and analysis are contained within the FOM II pistol.

3.

The lean meat content of carcase shall be calculated according to the following formula:

Image = 66,5015 – 0,3568 x1 – 0,4704 x2 + 0,0947 x3

where:

Image

=

the estimated percentage of lean meat in carcase.

4.

The measurement points are:

x1

=

the thickness of backfat (including rind) in millimetres, measured at 8 cm off the midline of the carcase between the third and fourth last lumbar vertebrae.

x2

=

the thickness of backfat (including rind) in millimetres, measured at 6 cm off the midline of the carcase between the third and fourth last ribs.

x3

=

the thickness of muscle in millimetres, measured at the same time and in the same place as x2.

The formula shall be valid for carcases weighing between 50 and 110 kg.


ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

10.1.2009   

EN

Official Journal of the European Union

L 6/89


DECISION No 1/2008 OF THE JOINT VETERINARY COMMITTEE SET UP BY THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON TRADE IN AGRICULTURAL PRODUCTS

of 23 December 2008

regarding the amendment of Appendices 2, 3, 4, 5, 6 and 10 to Annex 11 to the Agreement

(2009/13/EC)

THE JOINT COMMITTEE,

Having regard to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (hereinafter referred to as ‘the Agriculture Agreement’), and in particular Article 19(3) of Annex 11 thereto,

Whereas:

(1)

The Agriculture Agreement entered into force on 1 June 2002.

(2)

Under Article 19(1) of Annex 11 to the Agriculture Agreement, the Joint Veterinary Committee is responsible for considering any matter arising in connection with the said Annex and its implementation, and for the tasks provided for therein. Article 19(3) of that Annex authorises the Joint Veterinary Committee to amend the appendices thereto, in particular with a view to their adaptation and updating.

(3)

The Appendices to Annex 11 to the Agriculture Agreement were amended for the first time by Decision No 2/2003 of the Joint Veterinary Committee set up by the Agreement between the European Community and the Swiss Confederation on trade in agricultural products of 25 November 2003 amending Appendices 1, 2, 3, 4, 5, 6 and 11 to Annex 11 to the Agreement (1).

(4)

The Appendices to Annex 11 to the Agriculture Agreement were last amended by Decision No 1/2006 of the Joint Veterinary Committee created by an Agreement between the European Community and the Swiss Confederation on trade in agricultural products of 1 December 2006 amending Appendices 1, 2, 3, 4, 5, 6 and 10 to Annex 11 to the Agreement (2).

(5)

The Swiss Confederation (hereinafter referred to as ‘Switzerland’) has undertaken to incorporate into its national legislation the provisions of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries (3), Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (4), Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (5), Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (6), and all the provisions adopted for their implementation in the control of imports from third countries into the European Union.

(6)

In order to provide the resources needed for carrying out import controls on products of animal origin from third countries, it is necessary for Switzerland to be included, at least partially, in the rapid alert system established by Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7).

(7)

The health measures provided for by Swiss legislation and Community legislation for veterinary checks on movements and imports of animals and products of animal origin are recognised as being equivalent. Appendices 5 and 10 to Annex 11 to the Agreement therefore need to be amended.

(8)

Switzerland has undertaken to incorporate into its national legislation the provisions of Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals (8).

(9)

Appendices 2, 3, 4 and 6 to Annex 11 to the Agreement need to be amended to take account of changes in the Community and Swiss legislation in force on 30 June 2008,

HAS DECIDED AS FOLLOWS:

Article 1

Appendix 2 to Annex 11 to the Agriculture Agreement shall be amended in accordance with Annex I to this Decision.

Article 2

Appendices 3, 4, 5, 6 and 10 to Annex 11 to the Agriculture Agreement shall be amended in accordance with Annexes II to VI to this Decision.

Article 3

This Decision, drawn up in duplicate, shall be signed by the joint chairmen or other persons empowered to act on behalf of the parties.

Article 4

This Decision shall enter into force on the day of the entry into force of the Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (hereinafter the ‘Annex 11 Agreement’).

If the Annex 11 Agreement is applied provisionally, this Decision shall also be applied provisionally as from the same date pending the entry into force of the Agreement.

Article 5

This Decision shall be published in the Official Journal of the European Union.

Signed at Paris, on 23 December 2008.

On behalf of the Swiss Confederation

The Head of Delegation

Hans WYSS

Signed at Paris, on 23 December 2008.

On behalf of the European Community

The Head of Delegation

Paul VAN GELDORP


(1)  OJ L 23, 28.1.2004, p. 27.

(2)  OJ L 32, 6.2.2007, p. 91.

(3)  OJ L 268, 24.9.1991, p. 56.

(4)  OJ L 24, 30.1.1998, p. 9.

(5)  OJ L 18, 23.1.2003, p. 11.

(6)  OJ L 165, 30.4.2004, p. 1.

(7)  OJ L 31, 1.2.2002, p. 1.

(8)  OJ L 146, 13.6.2003, p. 1.


ANNEX I

Appendix 2 to Annex 11 is supplemented as follows:

‘X.   Non-commercial movements of pet animals

A.   LEGISLATION (1)

Community

Switzerland

Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (OJ L 146, 13.6.2003, p. 1).

Ordinance on the importation of pet animals (OIAC) of 18 April 2007 (RS 916.443.14).

B.   SPECIAL RULES AND PROCEDURES FOR IMPLEMENTATION

1.

The identification system shall be the one provided for in Regulation (EC) No 998/2003.

2.

The validity of the anti-rabies vaccination and, if relevant, of the revaccination shall be recognised in accordance with the recommendations of the laboratory of manufacture and pursuant to Article 5 of Regulation (EC) No 998/2003 and Commission Decision 2005/91/EC of 2 February 2005 establishing the period after which the anti-rabies vaccination is considered as valid (2).

3.

The passport to be used is that provided for in Commission Decision 2003/803/EC of 26 November 2003 establishing a model passport for the intra-Community movements of dogs, cats and ferrets (3).

4.

For the purposes of this Appendix, the provisions of Chapter II (Provisions applicable to movement between Member States) of Regulation (EC) No 998/2003 shall apply mutatis mutandis to the non-commercial movement of pet animals between the Member States of the Community and Switzerland.’.


(1)  Unless indicated otherwise, any reference to an act shall mean that act as amended before 30 June 2008.

(2)  OJ L 31, 4.2.2005, p. 61.

(3)  OJ L 312, 27.11.2003, p. 1.


ANNEX II

Appendix 3 to Annex 11 is replaced as follows:

‘Appendix 3

IMPORTS OF LIVE ANIMALS, THEIR SEMEN, OVA AND EMBRYOS FROM THIRD COUNTRIES

I.   Community — Legislation (1)

A.   Ungulates, excluding Equidae

Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (OJ L 139, 30.4.2004, p. 320).

B.   Equidae

Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae (OJ L 224, 18.8.1990, p. 42).

C.   Poultry and hatching eggs

Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 303, 31.10.1990, p. 6).

D.   Aquaculture animals

Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).

E.   Bovine embryos

Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1).

F.   Bovine semen

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10).

G.   Porcine semen

Council Directive 90/429/EEC of 26.6.1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62).

H.   Other live animals

1.

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).

2.

Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (OJ L 146, 13.6.2003, p. 1).

I.   Other specific provisions

1.

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of β-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3).

2.

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).

II.   Switzerland — Legislation (2)

1.

Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE), (RS 916.443.10);

2.

Ordinance of 18 April 2007 on the import and transit of animals by air from third countries (OITA), (RS 916.443.12);

3.

Ordinance of 18 April 2007 on the import and transit of animal products by air from third countries (OITPA), (RS 916.443.13);

4.

Ordinance of the DFE of 16 May 2007 on controls on the import and transit of animals and animal products (Ordinance on controls, OITE), (RS 916.443.106);

5.

Ordinance of 18 April 2007 on the importation of pet animals (OIAC) (RS 916.443.14);

6.

Ordinance of 18 August 2004 on veterinary medicinal products (OMédV), (RS 812.212.27);

7.

Ordinance of 30 October 1985 on the fees levied by the Federal Veterinary Office (OEVET), (RS 916.472).

III.   Implementing rules

The Federal Veterinary Office shall apply, simultaneously with the Member States of the Community, the import conditions set out in the acts mentioned in point I of this Appendix, the implementing measures and the lists of establishments from which the corresponding imports are authorised. This undertaking shall apply to all the relevant acts, irrespective of their date of adoption.

The Federal Veterinary Office may adopt more restrictive measures and require additional guarantees. Consultations shall be held within the Joint Veterinary Committee to find suitable solutions.

The Federal Veterinary Office and the Member States of the Community shall notify each other of the specific import conditions established bilaterally, which have not been harmonised at Community level.

For the purposes of this Annex, for Switzerland, Zürich Zoo is accepted as an approved centre in accordance with Annex C to Directive 92/65/EEC.’.


(1)  Unless indicated otherwise, any reference to an act shall mean that act as amended before 30 June 2008.

(2)  Unless indicated otherwise, any reference to an act shall mean that act as amended before 30 June 2008.


ANNEX III

Appendix 4 to Annex 11 is replaced as follows:

‘Appendix 4

ZOOTECHNICAL PROVISIONS, INCLUDING THOSE GOVERNING IMPORTS FROM THIRD COUNTRIES

A.   Legislation (1)

Community

Switzerland

Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding animals of the bovine species (OJ L 206, 12.8.1977, p. 8).

Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (OJ L 382, 31.12.1988, p. 36).

Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species (OJ L 167, 26.6.1987, p. 54).

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10).

Council Directive 89/361/EEC of 30 May 1989 concerning pure-bred breeding sheep and goats (OJ L 153, 6.6.1989, p. 30).

Council Directive 90/118/EEC of 5 March 1990 on the acceptance of pure-bred breeding pigs for breeding (OJ L 71, 17.3.1990, p. 34).

Council Directive 90/119/EEC of 5 March 1990 on the acceptance of hybrid breeding pigs for breeding (OJ L 71, 17.3.1990, p. 36).

Council Directive 90/427/EEC of 26 June 1990 on the zootechnical and genealogical conditions governing intra-Community trade in equidae (OJ L 224, 18.8.1990, p. 55).

Council Directive 90/428/EEC of 26 June 1990 on trade in equidae intended for competitions and laying down the conditions for participation therein (OJ L 224, 18.8.1990, p. 60).

Council Directive 91/174/EEC of 25 March 1991 laying down zootechnical and pedigree requirements for the marketing of pure-bred animals and amending Directives 77/504/EEC and 90/425/EEC (OJ L 85, 5.4.1991, p. 37).

Council Directive 94/28/EC of 23 June 1994 laying down the principles relating to the zootechnical and genealogical conditions applicable to imports from third countries of animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred breeding animals of the bovine species (OJ L 178, 12.7.1994, p. 66).

Ordinance of 14 November 2007 on animal breeding (RS 916.310).

B.   Implementing rules

For the purposes of this Appendix, live animals and animal products traded between the Member States of the Community and Switzerland shall circulate under the conditions established for trade between the Member States of the Community.

Without prejudice to the provisions on zootechnical checks in Appendices 5 and 6, the Swiss authorities undertake to ensure that Switzerland applies to its imports the same provisions as those in Council Directive 94/28/EC.

Where difficulties arise, the matter shall be referred to the Joint Veterinary Committee at the request of either party.’.


(1)  Unless indicated otherwise, any reference to an act shall mean that act as amended before 30 June 2008.


ANNEX IV

Appendix 5 to Annex 11 is replaced as follows:

‘Appendix 5

LIVE ANIMALS, THEIR SEMEN, OVA AND EMBRYOS: BORDER CHECKS AND INSPECTION FEES

CHAPTER I

General provisions — TRACES system

A.   LEGISLATION (1)

Community

Switzerland

Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the TRACES system and amending Decision 92/486/EEC (OJ L 94, 31.3.2004, p. 63).

1.

Law of 1 July 1966 on epizootic diseases (LFE), (RS 916.40);

2.

Ordinance of 27 June 1995 on epizootic diseases (OFE), (RS 916.401);

3.

Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE), (RS 916.443.10);

4.

Ordinance of 18 April 2007 on the import and transit of animals by air from third countries (OITA), (RS 916.443.12);

5.

Ordinance of 18 April 2007 on the import and transit of animal products by air from third countries (OITPA), (916.443.13);

6.

Ordinance of the DFE of 16 May 2007 on controls on the import and transit of animals and animal products (Ordinance on controls, OITE), (RS 916.443.106);

7.

Ordinance of 18 April 2007 on the importation of pet animals (OIAC), (RS 916.443.14).

B.   IMPLEMENTING RULES

The Commission, in cooperation with the Federal Veterinary Office, shall integrate Switzerland into the TRACES system, in accordance with Commission Decision 2004/292/EC.

If necessary, transitional and complementary measures shall be laid down by the Joint Veterinary Committee.

CHAPTER II

Veterinary and zootechnical checks applicable in trade between the Member States of the Community and Switzerland

A.   LEGISLATION (1)

Veterinary and zootechnical checks applicable in trade between the Member States of the Community and Switzerland shall be carried out in accordance with the provisions of the following acts:

Community

Switzerland

1.

Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (OJ L 351, 2.12.1989, p. 34).

2.

Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (OJ L 224, 18.8.1990, p. 29).

1.

Law on epizootic diseases (LFE) of 1 July 1966, (RS 916.40), and in particular Article 57 thereof;

2.

Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE), (RS 916.443.10);

3.

Ordinance of the DFE of 16 May 2007 on controls on the import and transit of animals and animal products (Ordinance on controls, OITE), (RS 916.443.106);

4.

Ordinance of 18 April 2007 on the importation of pet animals (OIAC), (RS 916.443.14);

5.

Ordinance of 30 October 1985 on the fees levied by the Federal Veterinary Office (OEVET), (RS 916.472).

B.   GENERAL IMPLEMENTING RULES

In the cases provided for in Article 8 of Directive 90/425/EEC, the competent authorities of the place of destination shall contact the competent authorities of the place of dispatch without delay. They shall take all necessary measures and notify the competent authority of the place of dispatch and the Commission of the nature of the checks carried out, the decisions taken and the reasons for such decisions.

The Joint Veterinary Committee shall be responsible for the application of the provisions of Articles 10, 11 and 16 of Directive 89/608/EEC and Articles 9 and 22 of Directive 90/425/EEC.

C.   SPECIAL RULES APPLICABLE TO ANIMALS SENT FOR GRAZING IN BORDER AREAS

1.

Definitions:

 

Grazing: dispatching animals to a Member State or to Switzerland with a view to grazing in a 10 km strip on either side of the border. In special, duly substantiated conditions, a wider strip on either side of the border between Switzerland and the Community may be authorised by the competent authorities concerned.

 

Daily grazing: grazing where the animals are returned to their holding of origin in a Member State or in Switzerland at the end of each day.

2.

In the event of grazing between the Member States of the Community and Switzerland, Commission Decision 2001/672/EC of 20 August 2001 laying down special rules applicable to movements of bovine animals when put out to summer grazing in mountain areas (OJ L 235, 4.9.2001, p. 23) shall apply mutatis mutandis. However, for the purposes of this Annex, the following adjustments shall apply to Article 1 of Decision 2001/672/EC:

the reference to the period from 1 May to 15 October shall be replaced by “the calendar year”;

for Switzerland, the parties referred to in Article 1 of Decision 2001/672/EC and referred to in the corresponding Annex shall be:

SWITZERLAND

CANTON OF ZÜRICH

CANTON OF BERN/BERNE

CANTON OF LUZERN

CANTON OF URI

CANTON OF SCHWYZ

CANTON OF OBWALDEN

CANTON OF NIDWALDEN

CANTON OF GLARIS

CANTON OF ZUG

CANTON OF FRIBOURG

CANTON OF SOLOTHURN

CANTON OF BASEL STADT

CANTON OF BASEL LAND

CANTON OF SCHAFFHAUSEN

CANTON OF APPENZELL AUSSERRHODEN

CANTON OF APPENZELL INNERRHODEN

CANTON OF SANKT GALLEN

CANTON OF GRAUBÜNDEN

CANTON OF AARGAU

CANTON OF THURGAU

CANTON OF TICINO

CANTON OF VAUD

CANTON OF VALAIS/WALLIS

CANTON OF NEUCHÂTEL

CANTON OF GENEVA

CANTON OF JURA.

Pursuant to the Ordinance on epizootic diseases (OFE) of 27 June 1995 (RS 916.401), and in particular Article 7 thereof (registration), and the Ordinance of 23 November 2005 on the database on animal movements (RS 916.404), and in particular Section 2 thereof (content of the database), Switzerland is to allocate to each pasturage a specific registration code which must be registered in the national database on bovine animals.

3.

In the case of grazing between the Member States of the Community and Switzerland, the official veterinarian of the country of dispatch shall:

(a)

on the date of issue of the certificate and no later than 24 hours before the planned date of arrival of the animals, by means of the computerised system linking veterinary authorities provided for in Article 20 of Directive 90/425/EEC, inform the competent authority of the place of destination (local veterinary unit) to which the animals have been dispatched;

(b)

examine the animals within 48 hours prior to their departure for the grazing ground; the animals must be duly identified;

(c)

issue a certificate in accordance with the model in point 9 below.

4.

Throughout the duration of the grazing period, the animals shall remain under customs control.

5.

The holder of the animals must:

(a)

agree, in a written statement, to comply with all measures taken pursuant to this Annex and any other measures introduced at local level, in the same way as any holder originating in a Member State or Switzerland;

(b)

pay the costs of the checks required pursuant to this Annex;

(c)

cooperate fully with arrangements for customs or veterinary checks required by the authorities of the country of dispatch or of destination.

6.

When the animals return at the end of the season or before, the official veterinarian of the country where the grazing ground is located shall:

(a)

on the date of issue of the certificate and no later than 24 hours before the planned date of arrival of the animals, by means of the computerised system linking veterinary authorities provided for in Article 20 of Directive 90/425/EEC, inform the competent authority of the place of destination (local veterinary unit) to which the animals have been dispatched;

(b)

examine the animals within 48 hours prior to their departure for the grazing ground; the animals must be duly identified;

(c)

issue a certificate in accordance with the model in point 9 below.

7.

In the event of outbreaks of disease, the competent veterinary authorities shall take appropriate measures by mutual agreement. Those authorities shall consider how to cover any costs involved. If necessary, the matter shall be referred to the Joint Veterinary Committee.

8.

As an exception to the rules on grazing in points 1 to 7, in the case of daily grazing between the Member States of the Community and Switzerland:

(a)

the animals shall not enter into contact with animals from another holding;

(b)

the holders of such animals shall undertake to inform the competent veterinary authority of any contact between their animals and animals from another holding;

(c)

the health certificate set out in point 9 below shall be presented to the competent veterinary authorities every calendar year when the animals first enter a Member State or Switzerland. This health certificate must be presented to the competent veterinary authorities at the request of the latter;

(d)

points 2 and 3 above shall apply only to the first time in each calendar year that the animals are dispatched to a Member State or to Switzerland;

(e)

point 6 shall not apply;

(f)

the holders of animals shall undertake to inform the competent veterinary authority of the end of the grazing period.

9.

Model health certificate for bovine animals sent for grazing or daily grazing in border areas and for bovine animals returning from border grazing:

Model health certificate for bovine animals sent for grazing or daily grazing in border areas and for bovine animals returning from border grazing

Image

Image

Image

CHAPTER III

Conditions applying to trade between the Community and Switzerland

A.   LEGISLATION

For trade in live animals and their semen, ova and embryos between the Community and Switzerland, and for the grazing of bovine animals in border areas between the Community and Switzerland, the health certificates shall be those provided for in this Annex and available in the TRACES system, in accordance with Commission Regulation (EC) No 599/2004 of 30 March 2004 concerning the adoption of a harmonised model certificate and inspection report linked to intra-Community trade in animals and products of animal origin (OJ L 94, 31.3.2004, p. 44).

CHAPTER IV

Veterinary checks applicable to imports of animals from third countries

A.   LEGISLATION (2)

Checks on imports from third countries shall be carried out in accordance with the provisions of the following acts:

Community

Switzerland

1.

Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of, and veterinary checks on, animals from third countries entering the Community (OJ L 49, 19.2.2004, p. 11);

2.

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1);

3.

Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (OJ L 268, 24.9.1991, p. 56);

4.

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of β-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3);