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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
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Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 230/2/12

16 March 2011

Dear Sirs,

Commercial Information Circular No. 169/2011

European Union (EU)* : Common Authorisation Procedure for Food Additives, Food Enzymes and Food Flavourings

Further to Commercial Information Circular No. 86/2009 dated 17 February 2009, the European Commission (the Commission) has adopted a Regulation to establish a common authorisation procedure for food additives, food enzymes and food flavourings. Details are set out in Commission Regulation (EU) No 234/2011, which can be accessed through the following link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:064:0015:0024:EN:PDF

DETAILS

2. Under the Article 9 of Regulation (EC) No 1331/2008, the Commission adopted the implementing measures as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, arrangements for checking the validity of applications and the type of information that should be included in the opinion of the European Food Safety Authority (the Authority). The Regulation shall apply to applications as referred to in Article 3(1) of Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. All applications shall consist of the information set out in Article 2 of the Regulation. 
 

3. For the risk assessment, the Regulation requires that the dossier submitted in support of an application for the safety evaluation of a substance shall enable a comprehensive risk assessment of the substance and shall permit verification that the substance does not pose a safety concern to consumers within the meaning of Article 6(a) of Regulation (EC) No 1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008 and Article 4(a) of Regulation (EC) No 1334/2008. The general provisions on data required for risk assessment are set out in Article 5 of the Regulation. Specific data required for risk assessment of food additives, food enzymes and food flavourings are set out in Articles 6, 8 and 10 respectively. 
 

4. As for risk management, the Regulation requires that the dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6(1) of Regulation (EC) No 1333/2008 for food additives and points (b) and (c) of Article 6 of Regulation (EC) No 1332/2008 for food enzymes. The dossier shall include the information set out in Articles 7, 9 and 11 for the risk management of food additives, food enzymes and flavourings respectively. 
 

5. Details about the procedure of checking the validity of an application are set out in Article 12 of the Regulation. The information to be provided in the opinion of the Authority is set out in Article 13 of the Regulation. 
 

6. To provide sufficient time for the applicants to comply with the provisions of the Regulation, the Regulation shall apply from 11 September 2011. 

ENQUIRIES

7. For enquiries concerning the content of this circular, please contact the undersigned at telephone number 2398 5556.

Yours faithfully,




(Miss Anita WONG)

for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.




　

Note ：

  • (1) While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.
  • (2)The biweekly newsletter "Business Alert - EU" of the Hong Kong Trade Development Council provides up-to-date information on the latest developments in EU trade policy and trade regulations. The newsletter is available for free e-subscription and can be accessed through
    http://www.tdctrade.com/alert/eualert.htm.