COMMISSION REGULATION (EC) No 1135/2009  
of 25 November 2009  
imposing special conditions governing the import of certain products originating in or consigned 
from China, and repealing Commission Decision 2008/798/EC  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European 
Community,  
Having regard to 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 (  1 ), and in particular 
Article 53(1)(b) thereof,  
Whereas:  
(1) Article 53 of Regulation (EC) No 178/2002 provides for 
the possibility to adopt appropriate Community 
emergency measures for food and feed imported from 
a third country in order to protect public health, 
animal health or the environment, where the risk 
cannot be contained satisfactorily by means of 
measures taken by the Member States individually.  
(2) The Commission was made aware in September 2008 
that high levels of melamine were found in infant milk 
and other milk products in China. To counter the health 
risk that may result from exposure to a high melamine 
content in feed and food products, Commission Decision 
2008/798/EC of 14 October 2008 imposing special 
conditions governing the import of products containing 
milk or milk products originating in or consigned from 
China, and repealing Commission Decision 
2008/757/EC (  2 ), provides for a prohibition on the 
importation into the Community of products containing 
milk or milk products, soya or soya products intended 
for the particular nutritional use of infants and young 
children, and requires Member States to perform 
systematic checks on all consignments originating in or 
consigned from China of feed and food containing milk, 
milk products, soya or soya products and of ammonium 
bicarbonate intended for food and feed. In that Decision 
the level of 2,5 mg/kg was considered to be the appro ­
priate level to distinguish between the unavoidable back ­
ground presence of melamine and unacceptable adul ­
teration.  
(3) The number of Rapid Alert System for Food and Feed 
(RASFF) notifications, as provided for in Article 2(4) of 
Decision 2008/798/EC, as regards unacceptable levels of melamine in those food and feed products from China 
has significantly decreased since January 2009, and the 
Chinese authorities have provided guarantees as regards 
the controls on melamine in such products exported to 
the Community. It is therefore appropriate to review the 
measures laid down in Decision 2008/798/EC.  
(4) Taking into account that products containing milk or 
milk products, soya or soya products that are intended 
for the particular nutritional use of infants and young 
children represent the primary, and in some cases sole, 
source of nourishment for infants and young children, it 
is appropriate to maintain the prohibition on 
importation into the Community of any such products 
originating from China. Member States should ensure 
that any such products found on the market are 
destroyed without delay.  
(5) At the same time, systematic checks on all consignments 
originating in or consigned from China of feed and food 
containing milk, milk products, soya or soya products 
and of ammonium bicarbonate intended for food and 
feed are no longer necessary given the significant 
decrease in RASFF notifications, so the intensity of 
physical checks should be reduced. Since the level of 
2,5 mg/kg continues to remain appropriate to distinguish 
between unavoidable background presence of melamine 
and unacceptable adulteration, products that contain a 
higher level of melamine should not enter the feed and 
food chain and should be safely disposed of.  
(6) Therefore, Decision 2008/798/EC should be amended 
accordingly. However, taking into account the nature of 
the amending provisions, it is appropriate to replace that 
Decision with a regulation, which could be reviewed at a 
later stage on the basis of the results of the controls 
carried out by the Member States.  
(7) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
For the purposes of this Regulation, references to China are to 
be understood as references to the People’s Republic of China.EN 26.11.2009 Official Journal of the European Union L 311/3  
( 1 ) OJ L 31, 1.2.2002, p. 1.  
( 2 ) OJ L 273, 15.10.2008, p. 18.Article 2  
Import prohibition  
1. The import into the Community of products containing 
milk, milk products, soya or soya products intended for the 
particular nutritional use of infants and young children within 
the meaning of Directive 2009/39/EC of the European 
Parliament and of the Council of 6 May 2009 on foodstuffs 
intended for particular nutritional uses (  1 ), originating or 
consigned from the People’s Republic of China shall be 
prohibited.  
2. Member States shall ensure that any such product found 
on the market shall be immediately withdrawn and destroyed.  
Article 3  
Prior notification  
Feed and food business operators or their representatives shall 
give prior notification to the control point referred to in 
Article 4(3) of the estimated date and time of arrival of all 
consignments originating in or consigned from China of 
ammonium bicarbonate intended for food and feed and of 
feed and food containing milk, milk products, soya or soya 
products.  
Article 4  
Control measures  
1. The competent authorities of the Member States shall 
carry out documentary, identity and physical checks, including 
laboratory analysis on the consignments originating in or 
consigned from China, which are to be imported into the 
Community, of ammonium bicarbonate intended for food and 
feed and of feed and food containing milk, milk products, soya 
or soya products other than those referred to in Article 2(1).  
Identity and physical checks, including sampling and analysis to 
control the presence of melamine, shall be carried out on 
approximately 20 % of such consignments.  
Member States may carry out random physical checks on other 
feed and food products with a high protein content originating 
from China, which are to be imported into the Community.  
The physical checks referred to in this paragraph shall in 
particular aim at ascertaining the level of melamine, if any, in the product. Consignments shall be kept under official control 
pending the availability of the results of the laboratory analysis.  
2. Any product found to contain more than 2,5 mg/kg 
melamine, following controls performed in accordance with 
paragraph 1, shall not enter the feed and food chain and 
shall be safely disposed of.  
3. The checks referred to in paragraph 1 shall be carried out 
at control points specifically designated by the Member States 
for that purpose.  
Member States shall make the list of control points available to 
the public and communicate it to the Commission.  
4. The release for free circulation of consignments shall be 
subject to the presentation by the feed and food business 
operator or their representative to the custom authorities of 
the evidence that the official controls referred to in paragraph 
1 have been carried out and favourable results from physical 
checks, where such checks are required, are known.  
Article 5  
Reports  
Member States shall submit to the Commission every three 
months a report of all analytical results of the controls 
referred to in Article 4(1). Those reports shall be submitted 
during the month following each quarter.  
Article 6  
Costs  
All costs resulting from the official controls referred to in 
Article 4(1), including sampling, analysis, storage and any 
measures taken following non-compliance, shall be borne by 
the feed and food business operator.  
Article 7  
Repeal  
Commission Decision 2008/798/EC is repealed.  
References to the repealed Decision shall be construed as 
references to this Regulation.EN L 311/4 Official Journal of the European Union 26.11.2009  
( 1 ) OJ L 124, 20.5.2009, p. 21.Article 8  
Entry into force  
This Regulation shall enter into force on the 20th day following its publication in the  Official Journal of the 
European Union . 
It shall apply from the date of entry into force.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 25 November 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the CommissionEN 26.11.2009 Official Journal of the European Union L 311/5