STANDING COMMITTEE ON THE FOOD CHAIN-TOXICOLOGICAL SAFETY

MEETING OF 12 FEBRUARY 2004

SUMMARY REPORT

1. Discussion and possible opinion on a draft Commission Directive amending

Commission Directive 95/45/EC laying down specific purity criteria concerning
colours for use in foodstuffs (Document SANCO/5345/2003): The Committee
expressed a unanimously favourable opinion.

2. Discussion and possible opinion on a draft Commission Directive amending

Commission Directive 95/31/EC laying down specific purity criteria concerning
sweeteners for use in foodstuffs (Document SANCO/5349/2003): The Committee
expressed a unanimously favourable opinion.

3. Discussion and possible opinion on a draft Commission Directive amending

Commission Directive 96/77/EC laying down specific purity criteria on food
additives other than colours and sweeteners (Document SANCO/5348/2003): The
Committee expressed a unanimously favourable opinion.

4. Exchange of views and possible opinion on a draft Commission Decision amending

Decision 1999/217/EC as regards the register of flavouring substances
(SANCO/2495/2003): The register was adopted in application of Regulation 2232/96/EC.
Following the evaluation programme laid down in Commission Regulation 1565/EC, up-
dating of the register had become necessary.( technical adjustments to names, deletion of
substances for which deadlines for submission of information had passed, follow-up to a
scientific opinion, addition of newly developed substances notified by DE and NL in order
to ensure their inclusion in the evaluation programme). In response to questions from the
member States, the Commission proposed to convene a meeting of the experts working
group on flavourings. The Committee expressed a favourable opinion by qualified
majority (two Member States abstained).

5. Discussion and possible opinion on a draft Commission Regulation amending

Regulation (EC) No 466/2001 as regards aflatoxins and ochratoxin A in foods for
infants and young children (SANCO/0983/2002 rev. 6):

The draft Commission Regulation provides for of maximum level for aflatoxin B1 of 0.1
µg/kg and for ochratoxin A of 0.5 µg/kg in baby foods, processed cereal-based foods for
infants and young children and dietary foods for special medical purposes intended
specifically for infants. Furthermore, a level of 0.025 µg/kg for aflatoxin M1 is foreseen
for infant formula and follow-on formulae, including infant milk and follow-on milk.

The Committee agreed that maximum levels for aflatoxin B1 and ochratoxin A in baby
foods, processed cereal-based foods for infants and young children and dietary foods for
special medical purposes intended specifically for infants should refer to the dry matter.
The maximum level of aflatoxin M1 in infant formulae and follow-on formulae,
including infant milk and follow-on milk, refer to the product ready to use (marketed as
such or after reconstitution as instructed by the manufacturer).
 The Committee gave a favourable opinion by qualified majority

6. Discussion and possible opinion on a draft Commission Directive amending

Directive 98/53/EC and Directive 2002/26/EC as regards sampling methods and the
methods of analysis for the official control of the levels of aflatoxin and ochratoxin A
in food for infants and young children (SANCO/0095/2003 – rev 1):

The draft Commission Directive provides for

- sampling provisions for the control of aflatoxin B1 and ochratoxin A in foods for infants
and young children;
- a provision on the determination of the dry matter content;
- provisions to ensure that analytical results on ochratoxin A are reported and
interpreted for checking compliance in a uniform way.

The Committee expressed a unanimously favourable opinion.

7. Discussion and possible opinion on a draft Commission Regulation amending

Regulation (EC) No 466/2001 as regards dioxins in fish (edible parts)
(SANCO/0110/2003 – rev 1):

The draft Regulation foresees some minor amendments as the application of the
Regulation revealed the need for some clarifications of the description of the products or
the parts of the product to which the maximum level applies.

Given that more time is needed for implementing measures to ensure that dioxin levels in
free range or semi-intensive eggs are reduced, the draft regulation provides for an
extension of the transition period for one year i.e. until 31 December 2004.

The Committee expressed a favourable opinion by qualified majority

8. Discussion and possible opinion on a draft Commission Directive amending

Directive 2002/69/EC laying down the sampling methods and the methods of
analysis for the official control of dioxins and the determination of dioxin-like PCBs
in foodstuffs (SANCO/0111/2003 – rev 1 - amendment to the sampling provisions
for the control of dioxins in fish, addition of a definition for limit of quantification,
introduction of the concept of the measurement uncertainty):

The draft Commission Directive provides for

- specific sampling provisions for large whole fishes;
- a definition of a specific limit of quantification for the purpose of the application of this
Directive only;
- provisions to ensure that analytical results on dioxins are reported and interpreted for
checking compliance in a uniform way.

The Committee expressed a unanimously favourable opinion.

9. Discussion in view of the notification to WTO and transmission to the European
Parliament on a draft Commission Regulation amending Regulation 466/2001 as
regards ochratoxin

In accordance to Regulation (EC) No 466/2001, the provisions as regards ochratoxin A

(OTA) in dried vine fruit and with a view to including a maximum level for OTA in green
and roasted coffee and coffee products, wine, beer, grape juice, cocoa and cocoa products
and spices have been reviewed taking into account the investigations undertaken and the
prevention measures applied to reduce the presence of OTA in these products.

Given the significant contribution of wine and roasted coffee together with soluble coffee
to the OTA human exposure and the significant contribution of grape juice to the OTA
exposure of children, it is appropriate, in addition to the already existing maximum levels
for cereals and cereal products and dried vine fruit, to establish also for these foodstuffs
maximum levels to protect public health by preventing the distribution of unacceptably
highly contaminated foodstuffs
OTA has also been observed in dried fruit other than dried vine fruit, cocoa and cocoa
products, spices and licorice. The appropriateness of setting a maximum level for OTA in
these foodstuffs, including green coffee and beer, as well a review of the existing
maximum levels will be considered after the availability of the EFSA assessment of the
research results on OTA toxicology. This assessment is to be expected to become
available in the course of 2005. In the meantime, every effort should be made with regard
to research and prevention measures to reduce the presence of OTA in foodstuffs as much
as possible.

The maximum levels for OTA discussed were

- roasted coffee beans and ground roasted coffee: 5 µg/kg

- soluble coffee: 10 µg/kg
- wine and grape juice: 2 µg/kg

The Committee accepted by qualified majority that these draft measures are notified to
WTO for comments.

10. Discussion of guidelines on dioxins in the case of a finding of non-compliance with

the maximum levels on dioxins, traced back to a specific production site:

The Commission clarified that the document did not aim at giving guidance on the stages
of production where controls could be carried out, but on the action which should be
taken in case of unfavourable findings. It was agreed that the experts working group on
contaminants would reconsider the document at its next meeting, particularly in view of
extending the document to fish caught at sea or freshwater and that thereafter it would be
published on the website of the Directorate-General Health and Consumer Protection.
11. Discussion and possible opinion on a draft Commission Regulation amending
Regulation (EC) No 466/2001 as regards nitrate in foods for infants and young
children

The Committee expressed a favourable opinion by qualified majority on the proposal to

set maximum levels for nitrate in foods for infants and young children; one Member State
abstained. From the consultation on the proposal, a suggested higher maximum level had
been put forward, but the Committee did not support this higher level in the light of the
available scientific data. A maximum level of 200 mg/kg will apply to the listed categories
of foods from 1 October 2004. The level will apply to the foods as consumed.

12. Report on the relationship between analytical results, the measurement uncertainty,
recovery factors and the provisions in EU Food and Feed legislation:

The report addresses in particular the treatment of analytical variability (normally known
as measurement uncertainty) in the interpretation of a maximum level, the use of
recovery correction when calculating and reporting an analytical result and the number of
significant figures taking into account when reporting results. Different approaches taken
by countries do prevent the uniform implementation of legislative standards.
It is essential that interpretation of analytical results is equivalent across the EU.

The report describes in detail the issues in general of relevance for EU food and feed
legislation.
The recommendations made in the report relate for the time being only to the application
of Community legislation concerning contaminants in food (Council Regulation 315/93
laying down Community procedures for contaminants in food) and undesirable
substances in feed (Directive 2002/32/EC of the European Parliament and of the Council
of 7 may 2002 on undesirable substances in animal feed.

It was agreed that the document would be published on the website of the Directorate-
General Health and Consumer Protection.

13. Update on Acrylamide: The Commission highlighted new information that had been
placed on its website on 2 February 2004. The new information included a note of a
meeting with stakeholders, held on 20-21 October 2003, on ways to lower levels of
acrylamide formed in foods; and an update to the EU data base on research activities on
acrylamide.

14. Any other business

Review of maximum levels for heavy metals in food: Spain enquired about the
timescale for the review of legislation on heavy metals. The Commission advised that this
will become clearer after the meeting of the working group of experts on contaminants in
food on 26-27 February 2004.

Semicarbazide: The Commission informed the Committee that DG Health and Consumer
Protection had asked the Joint Research Centre (JRC) to co-ordinate a project that would
improve the of performance analytical methods to detect semicarbazide (SEM) and
nitrofurazone in food. The project is divided into 2 parts with a total of five subprojects
focussing on:
- the identification of an alternative indicator (marker residue) for nitrofurazone;
- the development and validation (in-house and collaborative trial) of analytical
methods for SEM analysis in various food products;
- baby food analysis (method validation, monitoring and investigation of sources for
contamination);
- the development and validation of a screening method for semicarbazide for food
products;
- the determination of the content of SEM in selected food products that are likely to
contain this substance.
Together with the activities managed by the European Food Safety Authority (EFSA),
focussing on the determination of the significance of SEM for in food for human health,
the JRC project would contribute to the determination of the sources of SEM, allow to
better differentiate these sources through chemical analysis and hopefully to allow
unambiguous determination of any illegal use of nitrofurazone in food producing animals.

Food irradiation: The Commission informed the Committee that the report on food
irradiation for 2002 would be published shortly and reminded the Member States of the
need to submit information in view of the report for 2003.

Residues in Food of Animal Origin: The Commission drew the attention of the
Committee to the publication jointly on the websites of the Directorates-General
Entreprise and Health and Consumer Protection of the Reflection Paper on Residues in
Food of Animal Origin and the deadline for comments by all stakeholders (20.3.04).

Annato (E 160 b) in chilli powder: Annato is allowed under Directive 94/36/EC as a

colour in a limited number of foods. The Commission drew the attention of the Committee
to the fact that FR and DE had found annato in chilli powder respectively from Spain and
Vietnam. This colour is not authorised in spices. In FR, the products concerned have been
recalled from the market. The incident is being followed through the Rapid Alert System
for Food and Feed.

Imports of peanut, pistachios etc after 1 May 2004: The Commission informed the
Committee that it had formally asked the new Member States to provide the list of entry
points in order to up-date all Decisions on import controls for aflatoxins before 1 May
2004. If such up-dates were not adopted, only entry points in the current Decisions would
be allowed, even after 1 May 2004.