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WG 10 09 05

WORKING DOCUMENTDOES NOT NECESSARILY

REPRESENT THE VIEWS OF THE COMMISSION

NOTE TO THE WORKING PARTY OF GOVERNMENTAL EXPERTS ON FOOD ADDITITVES

Subject : Review of the conditions of use of the so-called “Southampton colours”

In the general frame of the monitoring of food additives as set out in the previous Directive 89/107/EEC as well as Regulation (EC) No 1333/2008 (See Annex 1), the food colours were among the first food additives to be evaluated. Following the delivery of the “Southampton study”, EFSA re-evaluated the safety on use of the following colours Tartrazine, Quinoline yellow, Sunset yellow, Azorubine, Ponceau 4R, Allura Red and issued individual opinions for these six food colours (so called Southampton colours) on 12 November 2009 (see Annex 2).

1. STATE OF PLAY

The conclusions of EFSA can be briefly summarised as follows:

For 3 colours, namely Quinoline Yellow, Ponceau 4R, and Sunset Yellow FCF, there is an evident safety concern (very large exceedance of the Acceptable daily intake (ADI) for high consumers, both for children and adults (e.g. 550-880% ADI among children)). In addition, EFSA lowered the ADIs for these colours which are now very low, and set a temporary ADI for sunset yellow due to lack of toxicological data;

For 2 colours, namely Azorubine and Allura red, there is a slight exceedance of their ADIs;

For 1 colour, namely Tartrazine, there is no exceedance of the ADI;

Since December 2009, the main industry federations concerned were contacted to provide proposals for reduction of use levels or withdrawal of obsolete uses in some categories, as well as information on real use levels for these food additives. In April 2010, the Commission organised a meeting with representatives of the industry to discuss the data provided and required additional information, in particular in relation to the technological justifications and benefit of these colours. This information was provided by industry at the end of May 2010.

The Commission proposes to prioritise the work according to the outcome of the EFSA opinions on these colours and their respective health risk. This should be considered in relation with other developments:

a) a warning labelling for these six colours (i.e. “may have an adverse effect on activity and attention in children”) is now established under the current legislation (Annex V to Regulation (EC) No 1333/2008);

b) the re-evaluation by EFSA of 18 other colours as required in the EU Regulation 257/2010 on the program of re-evaluation for food additives for the year 2010;

c) the current work on a draft Regulation establishing the EU list of food additives (Annex II), for which a tight deadline for its completion is set for January 2011;

Therefore the Commission intends to revise at first instance the conditions of use for the Southampton colours for which there is a clear safety concern, i.e Quinoline Yellow, Ponceau 4R, and Sunset Yellow FCF, and to consider the other Southampton colours (for which there is only a slight exceedence of the ADI) “en bloc” all together with the other 18 colours, as soon as these colours will be issued by EFSA (the deadline is December 2010 (see Annex 3)).

2. TIME LINE

Bearing in mind the tight deadline (January 2011) foreseen for the completion of the draft Regulation establishing the EU list of food additives (Annex II) but also the number of issues that are likely to be raised by industry when restricting the use of colours, it seems difficult to include, at this stage, the revisions of uses of the Southampton colours into the Annex II. It is therefore proposed to decouple both exercises.

3. APPROACH TO BE CONSIDERED IN RELATION TO THE RESTRICTIONS TO BE FORESEEN

As regards the approach to be taken in order to ensure that the ADIs are not exceeded, the Commission would like to follow, in principle, an horizontal approach aiming at lowering the permitted use levels of these colours by a specific factor but also to withdraw obsolete authorisations, ensuring that the ADI is not exceeded. A specific attention should be paid also on the main contributors identified by EFSA (see Annex 4), especially if the considered foodstuffs are particularly consumed by children. It is indeed important to take into consideration during the discussions the fact that EFSA highlighted, at least for Quinoline yellow, ponceau, and Sunset yellow, that their ADIs are exceeded, in particular, by high consumer children.

The Commission services seek the opinion of the Member State experts on this approach.

4. REVISION OF THE CONDITIONS OF USE FOR QUINOLINE YELLOW, SUNSET YELLOW, AND PONCEAU 4R

The Annexes 5, 5a, 5b, 5c, 5d, 5e, 5f provide some detailed information on the proposed revisions of the current conditions of use for quinoline yellow, sunset yellow and Ponceau 4R. Commission services seek the opinion of the Member State experts on the proposed revised uses and use levels that are proposed for these colours.

Stéphane Brion

Annex 1

EFSA opinions on the re-evaluation of the six "Southampton" colours

Background:

Directive 89/107/EEC as well as Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives1 which applies as from 20 January 2010, require that food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. In addition, Regulation (EC) No 1333/2008 requires that all food additives which were permitted before 20 January 2009 shall be subject to a new risk assessment carried out by EFSA.

Food colours were among the first food additives to be evaluated. Therefore, many of the current evaluations are based on old studies. For some of these colours many new studies have become available and the results of these studies should be included in the evaluation. The re-evaluation of food colours by EFSA has already commenced.

In 2007, a study by McCann et al. (known as the 'Southampton study') examined the effect of mixtures of the colours Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E129), Tartrazine (E102) and Ponceau 4R (E124) on children's behaviour. EFSA examined the results of the above mentioned study and concluded that it provides limited evidence that the two mixtures of the additives tested had a small and statistically significant effect on activity and attention in children. The Panel also considered that the findings of the study cannot be used as a basis for altering the Acceptable Daily Intake (ADI) of the respective food colours.

On the basis of EFSA's opinion, the European Parliament and the Council deemed necessary to require that foods which contain one or more of the colours E110, E104, E122, E129, E102 and E124 should bear an additional warning labelling indicating that these colours may have an adverse effect on activity and attention in children, in order to allow consumers to make informed choices. Regulation (EC) No 1333/2008 makes this provision compulsory as of 20 July 2010.

Following this study, the Commission asked EFSA to re-evaluate with priority, within the ongoing re-evaluation of all authorised food additives, the colours examined in the Southampton study and the five other authorised azo colours (Amaranth (E 123), Brilliant Black BN (E 151), Brown FK (E 154), Brown HT (E 155) and Litholrubine BK (E 180)). EFA has already issued opinions for all of these azo-dyes. Currently, 11 remaining colours should be re-evaluated by EFSA before the end of 2010

1 OJ L 354, 31.12.2008, p. 16.

Annex 2

Re-evaluation of the safety on use of the Southampton colours

Main outcomes of the EFSA opinions (12 November 2009)

Food colour EFSA conclusions

Quinoline yellow (E104) ADI reduced from 10 to 0.5 mg/kg bw/day. Anticipated intake estimates could be above the revised

ADI both for adults and children Sunset yellow (E110) Due to uncertainties in the studies a temporary ADI of

1 mg/kg bw/day (previously 2.5 mg/kg bw/day) is set for two years until the required data (28 day study) is provided.

Anticipated intake estimates could be above the revised ADI both for adults and children

Ponceau 4R (E124) ADI reduced from 4 to 0.70 mg/kg bw/day Anticipated intake estimates could be above the revised

ADI both for adults and children Tartrazine,(E102) and ADI 7.5 mg/kg bw/day remains unchanged

Anticipated intake estimates are below the ADI Carmoisine (E122) ADI 4 mg/kg bw/day remains unchanged

Anticipated intake estimates are below the ADI. Only some children who consume large amounts of food and drinks containing this colour could exceed this ADI

Allura red (E129) ADI of 7 mg/kg bw/day remains unchanged. Anticipated intake estimates are generally below the

ADI. Only some children who consume large amounts of food and drinks containing this colour could exceed this ADI.

With regard to allergenic effects, EFSA noted some reports of sensitivity to these colours, but the available data did not support a causal link between these colours and sensitivity-type reactions. A full opinion on the allergenic effects of azo colours is expected by the end of this year.

In addition, EFSA affirmed its 2008 opinion on the so-called “Southampton study” (McCann et al., 2007), which linked certain mixtures of these colours to hyperactivity in children. Apart from this study, limited data are available on possible behavioural effects of these individual colours.

Annex 3

State of play for the reevaluation of colours to be evaluated by EFSA during the year 2010

Food colour Status Timeline for next discussion Comment from COMAmaranth AdoptedBrilliant Black BN AdoptedBrown FK, AdoptedBrown HT AdoptedLitholrubine BK AdoptedLutein AdoptedCurcumin AdoptedErythrosine Panel October 2010

Patent Blue V Panel November 2010

A call for data was launched on July 2010 by EFSA to obtain complementary information regarding the potential genotoxicity of the substance (15th Oct 2010 as deadline for Industry to provide these information)

Indigo carmine Panel November 2010Brilliant Blue FCF Panel October 10Green S Panel October 2010Caramel class I Panel

October 2010Caramel class II PanelCaramel class III PanelCaramel class IV PanelCanthaxanthin Panel September/October 2010Calcium carbonate WGA September 2010

Annex 4

Main food contributors identified by EFSA in relation to the use of the Southampton colours

- For children, EFSA identified non-alcoholic flavoured drinks, fine bakery wares, sauce, and desserts as main food contributors for all of the Southampton colours, while cake decorations (icing), ice creams and sorbets, food supplements, and snacks (potato, cereal based etc), surimi, jam, chorizo, salchichon, and confectionary were flagged up as main contributors, for at least one of these colours.

- For adults, EFSA spotted soft drinks as main contributor for all of the six colours, and often sauces and seasonings. Other main contributors like fruit wine, cider and perry, fine bakery ware, dessert are specifically involved in the exposure to one colour, the quinoline yellow.

Annex 5

Revisions of the condition of use of Quinoline yellow, sunset yellow, and Ponceau 4R

ISSUE

Directive 89/107/EEC as well as Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives2 requires that food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information.

Following a request from the Commission, the European Food Safety Authority (EFSA) re-evaluated the safety of the following colours Tartrazine (E 102), Quinoline yellow (E 104), Sunset yellow (E110), Azorubine (E 122), Ponceau 4R (E124); Allura red (E 129).

The recent opinions of EFSA reduced Acceptable Daily Intake (ADI) for three of these colours, namely Quinoline Yellow (E104), Sunset Yellow FCF (E110) and Ponceau 4R (E124). With regard to sunset yellow, a temporary ADI has been assigned (a 28 days study is required to clarify the effects of sunset yellow on the testis, sperm morphology and sperm mobility). EFSA also concluded that the exposure to these colours could exceed the new ADIs for both adults and children.

The dietary exposure of all of these colours was estimated by EFSA following a three step Tiered based approach (Budget method, Tier 2 and Tier 3). A refined exposure estimate was performed both for children and the adult population according to the Tier 2 and Tier 3 approaches which combines, respectively, detailed individual food consumption information from the population with the maximum permitted levels (MPLs) of use as specified in the Directive 94/36/EC on food colours (Tier 2), and when available, with the maximum reported use levels of these colours (Tier 3), as identified by EFSA from the data made available by the Industry sectors (FSA, FSAI, AFSSA, UNESDA, CEPS, ELC, and CIAA). The Annex 2 summarises the outcomes of the exposure estimates undertaken by EFSA for each of these colours.

For the children population (aged 1-10 years), estimates were calculated for nine European countries (Belgium, France, the Netherlands, Spain, UK, Czech Republic, Italy, Finland and Germany). For the adult population, EFSA selected the UK population as representative of EU consumers for the intake estimates of these colours.

Several industry federations, including ICGA (International Chewing Gum Association), AICV (Association des industries des cidres et vins de fruit de l’UE), Association des industries du poisson de l’UE (AIPCE), Confederation of the food and drink industries in the EU (CIAA), Federation of European Specialty Food Ingredient Industries (ELC), ERNA, European Responsible Nutrition Alliance (ERNA), OEIFTL, Euroglace, Eurocommerce had been contacted by the Commission, informing them about the issue and requesting them to provide it with up to date information in relation to the use and actual use levels of these colours in their respective sectors.

Based on the comprehensive set of data provided by CIAA including refined use and use levels of these food additives, it seems that, for a wide range of foodstuffs, these Southampton colours are used in very limited number of food, or the reformulation is underway, or these colours are not used any more (“no reported value3”). However, CIAA confirms that these colours are still widely used in soft drinks,

2 OJ L 354, 31.12.2008, p. 16.

3 Although it should be pay attention to the fact that some of the information provided by CIAA can not be considered as representative because some federation of specific sectors are not members of CIAA.

confectionary, fine bakery wares, and desserts. These foodstuffs were already identified by EFSA as main contributors.

Euroglace has informed us that these colours are no longer used in edible ices.

In fish derived products, according to AIPCEE, Southampton colours are not much used anymore, and/or alternatives have been found in some cases (e.g. sunset yellow in lumpfish).

CURRENT STATE OF PLAY AND ACTIONS TO BE TAKEN

The use of these colours is still regulated by the annexes of the European Parliament and Council Directive 94/36/EC as well as the Regulation EC (No) 1333/2008. These Annexes set out the foods in which colours can be added and their conditions of use/maximum levels. EFSA has identified, for each of the colours, the main food contributors which play a significant contribution in term of exposure. It is important to stress that for all of these colours, the following foodstuffs are always flagged up by EFSA for children: non-alcoholic flavoured drinks,fine bakery wares (e.g. biscuits, cakes, wafers), sauce, and desserts,

Other main food contributors appear to play a significant role to children exposure for one, or several colours: cake decorations (icing), ice creams and sorbets, , food supplements, and snacks (potato, cereal based etc), surimi, jam, chorizo, salchichon

With regard to adults, EFSA spotted soft drinks as main contributor for all of the six colours, and often sauces and seasonings. Other main contributors like fruit wine, cider and perry, fine bakery ware, dessert are specifically involved in the exposure to one colour, the quinoline yellow.

Based on the EFSA opinions, there is a need to revise the conditions of use and use levels for these food additives, especially for ponceau 4R, quinoline yellow and sunset yellow for which the ADIs have been drastically lowered and the exposure estimates for high consumer children are well above the new ADIs.

Taking into account the information provided by industry but also the foodstuffs that have been highlighted by EFSA as main contributors, the Annex 5 proposes some changes in terms of condition of use and use levels for these colours in order to ensure that the respective ADIs of these colours are no longer exceeded, even for the high consumers

It is important to highlight that the current legislation of colours, in its Annex V, Part 2 already foresees that the following colours E 110 (sunset yellow), E 122 (Azorubine), E 124 (Ponceau 4R) and E 155 (Brown HT) may not exceed 50 mg/kg (or mg/l), singly or in combination, when added to non-alcoholic flavoured drinks, edible ice, dessert, fine bakery wares and confectionary.

The modifications proposed in the Annex 5 are based mainly on the percentage of ADI exceedance obtained from EFSA for high consumers. The proposal suggest to adopt an horizontal approach to reduce permitted maximum limits by a specific factor ensuring that the revised maximum limit do not exceed the ADI anymore. But the proposal takes into account also the various comments provided by the industry. For instance, the draft proposes to withdraw authorisations for those colours that are no longer used in specific foodstuffs or for which the technological justification may be questioned.

Annex 5a

Background information on Quinoline Yellow (E 104)

ADI reduced from 10 mg/kg bw/d to 0.5 mg/kg bw/d;

anticipated intake estimates could be significantly above the ADI both for adults and children (800% ADI for high children consumers;

main contributors : soft drinks, fine bakery wares, desserts, confectionary, surimi, sauces and seasonings, fruit wines;

Quinoline Yellow is already permitted in the EU as a food colour and was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1984, and the EU Scientific Committee for Food (SCF) in 1984. Both committees established an ADI of 0-10 mg/kg bw. The European Food Safety Authority re-evaluated the use of quinoline yellow in food and recommended to lower down the ADI from 10 mg/kg bw/d to 0.5 mg/kg bw/d in its opinion on 23 September 20094

EFSA considered that the long-term chronic toxicity/carcinogenicity study should be used as the pivotal study to redefine the ADI. Using a NOAEL of 50 mg/kg bw/day and applying an uncertainty factor of 100, EFSA significantly lowered the existing ADI from 10 mg/kg to 0.5 mg/kg bw/day.

For information, Quinoline yellow has not been approved by the US food drug administration as a colour and is therefore not authorised in the USA.

When considering the Tier 2 approach (based on MLs), the mean dietary exposure to Quinoline Yellow for European children (1-10 years old) ranged from 0.8 to 3.5 mg/kg bw/day and from 1.8 to 9.6 mg/kg bw/day at the 95th percentile. When considering the Tier 3 approach based on the maximum reported use levels, the mean dietary exposure to Quinoline Yellow ranged from 0.45 to 2.0 mg/kg bw/day, and from 1.1 to 4.1 mg/kg bw/day at the 95th percentile.

Therefore, the refined exposure Tier 3 indicates that the exposure estimates of quinoline yellow are extremely important for high consumer children and well over the newly ADI of 0.5 mg/kg bw/day established by EFSA (more than 800 % ADI).

For the children, the main contributors flagged up by EFSA are the following categories (with the most significant indicated in bold): soft drinks, fine bakery wares, desserts, confectionary, surimi, sauces and seasonings (the respective ranges of contributions for these foodstuffs are indicated in Annex 2).

For the adult population, EFSA selected the UK population as representative of the EU consumers for Quinoline Yellow exposure estimates. When considering the Tier 3 approach, estimates reported for the UK adult population give a mean dietary exposure to Quinoline Yellow of 0.5 mg/kg bw/day and of 1.2 mg/kg bw/day for high level (97.5th percentile) consumers of soft drinks.

The refined exposure Tier 3 indicates that the intake estimates of quinoline yellow are important for high consumers adults and above the ADI of 0.5 mg/kg bw/day established by EFSA (more than 200 % ADI). The soft drinks contribute significantly in the exceedance of the ADI.

For the adults, the main contributors flagged up by EFSA are the following categories: soft drinks, fine bakery wares, fruit wines, cider and Perry, desserts (see Annex 2).

4 Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of Quinoline yellow (E 104) when used as a food additive, The EFSA Journal 2009; 7(11):1329. [40 pp.].

Annex 5b

Background information on Ponceau 4R (E 124)

ADI reduced from 4 to 0.7 mg/kg bw/d ;

anticipated intake estimates could be above the ADI both for adults and children (880% ADI for high children consumers).

main contributors : soft drinks, fine bakery wares, desserts, sauces and seasonings, chorizo, salchichon, jam

Ponceau 4R is an azo-dye colour already permitted in the EU legislation as a food additive and was previously evaluated by the JECFA in 1983 and the SCF in 1984. Both committees established an ADI of 0-4 mg/kg body weight (bw)/day. EFSA re-evaluated the use of ponceau 4R in food and recommended to lower down the ADI from 4 mg/kg bw/d to 0.7 mg/kg bw/d in its opinion5 on 23 September 2009.

EFSA considered that findings of glomerulonephrosis in a mouse study should be taken into consideration and give reason for the redefinition of the ADI.

When considering the Tier 2 approach (based on MPLs), the mean dietary exposure to Ponceau 4R for European children (aged 1-10 years) ranged from 0.3 to 2.5 mg/kg bw/day and from 0.6 to 6.7 mg/kg bw/day at the 95th percentile. When considering the maximum reported use levels (Tier 3), the mean dietary exposure of European children ranged from 0.3 to 2.4 mg/kg bw/day and from 0.7 to 6.2 mg/kg bw/day at the 95th percentile. Therefore, the refined exposure Tier 3 indicates that the intake estimates of Ponceau 4R are extremely important for high consumers children and well above the ADI of 0.7 mg/kg bw/day established by EFSA (around 880 % ADI).

For the children, the main contributors flagged up by EFSA are the following categories (with the most significant indicated in bold): soft drinks, fine bakery wares, desserts, sauces and seasonings, jam, chorizo and salchichon (the respective ranges of contributions for these foodstuffs are indicated in Annex 2).

For the adult population, EFSA selected the UK population as representative of the EU consumers for Ponceau 4R intake estimates. Estimates reported for the UK adult population give a mean dietary exposure of 0.4 mg/kg bw/day and of 1.0 mg/kg bw/day for high level (97.5th percentile) consumers of soft drinks.

EFSA concluded that at the maximum levels of use of Ponceau 4R, intake estimates for adults at the high percentile (97.5th) are generally above the ADI of 0.7 mg/kg bw/day even in the refined intake estimates (Tier 2 and Tier 3). The main contributors are soft drinks, sauces and seasonings.

It is important to highlight that the current legislation of colours, in its Annex V, Part 2 already foresees that the following colours E 110 (sunset yellow), E 122 (Azorubine), E 124 (Ponceau 4R) and E 155 (Brown HT) may not exceed 50 mg/kg (or mg/l), singly or in combination, when added to non-alcoholic flavoured drinks, edible ice, dessert, fine bakery wares and confectionary.

5 Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of Ponceau 4R (E 124) as a food additive, The EFSA Journal 2009; 7(11):1328

Annex 5c

Background information on Sunset yellow FCF (E 110)

ADI reduced from 2.5 to temporary ADI 1 mg/kg bw/d

anticipated intake estimates could be above the ADI both for adults and children (580 % ADI for high children consumers).

main contributors : soft drinks, fine bakery wares, desserts, sauces and seasonings, surimi

The Sunset Yellow FCF is an azo dye permitted in the EU as a food additive and was previously evaluated by the JECFA in 1982 and the SCF in 1984. Both committees established an ADI of 0-2.5 mg/kg bw/day. EFSA re-evaluated the use of sunset yellow in food and recommended to assign a temporary ADI to sunset yellow and to lower down the numerical value from 2.5 mg/kg bw/d to 1 mg/kg bw/d in its opinion6 on 24 September 2009.

A temporary ADI has been assigned because clarification is requested in relation to the effects of sunset yellow on the testis, sperm morphology and sperm mobility. In light of the uncertainties observed, EFSA decided to reduce the existing ADI by an extra uncertainty factor of 2.5.

When considering the maximum reported use levels (Tier 3), the mean dietary exposure to Sunset Yellow FCF for European children (aged 1-10 years) ranged from 0.2 mg/kg bw/day to 2.1 mg/kg bw/day and from 0.6 mg/kg bw/day to 5.8 mg/kg bw/day at the 95th percentile. Therefore, the refined exposure Tier 3 indicates that the intake estimates of Sunset yellow are extremely important for high consumers children and well above the ADI of 1 mg/kg bw/day established by EFSA (around 580 % ADI).

For the children, the main contributors flagged up by EFSA are the following categories (with the most significant indicated in bold): soft drinks, fine bakery wares, desserts, sauces and seasonings, surimi (the respective ranges of contributions for these foodstuffs are indicated in Annex 2).

Estimates reported for the UK adult population give a mean dietary exposure to Sunset Yellow FCF of 0.3 mg/kg bw/day and of 0.9 mg/kg bw/day for high level (97.5th percentile) consumers of soft drinks.

It is important to highlight that the current legislation of colours, in its Annex V, Part 2 foresees specific provisions for the following colours E 110 (sunset yellow), E 122 (Azorubine), E 124 (Ponceau 4R) and E 155 (Brown HT) which may not exceed 50 mg/kg (or mg/l), singly or in combination, when added to non-alcoholic flavoured drinks, edible ice, dessert, fine bakery wares and confectionary.

6 Scientific opinion of the Panel on Food Additives and Nutrient sources added to Food (ANS) on a request from the Commission related to the re-evaluation on the safety of sunset yellow (E 110) when used as a food additive, The EFSA Journal 2009; 7(11):1330

Annex 5d

PROPOSED REVISION OF THE CONDITIONS OF USE OF QUINOLINE YELLOW

Annex III

In the entry related to Americano, the reference to E104 Quinoline Yellow is deleted and another entry is added:

Americano E104 Quinoline Yellow 12 mg/kg

In the entry related to Bitter soda, bitter vino as mentioned in Regulation (EEC) No 1601/91, the reference to E104 Quinoline Yellow is deleted and another entry is added:

soda, bitter vino as mentioned in Regulation (EEC) No 1601/91

E104 Quinoline Yellow 12 mg/kg

In the entry related to jam, jellies and marmalades as mentioned in Directive 79/693/EEC and other similar fruit preparations including low calorie products, the entry to E 104 Quinoline Yellow in the second column is deleted:

Annex V, Part 2 to Directive 94/36/EC shall be amended as follows:

a) The food additive “E 104, Quinoline yellow” mentioned in the list of Annex V, Part 2 to Directive 94/36/EC, shall be deleted from this list.

b) In Annex V, a new Part 3 shall be added as follows:

“Colour Foodstuffs Current Maximum permitted

level

(basis for the Tier 2

evaluation)

Maximum permitted use levels considered by

EFSA when performing the Tier 3 exposure

assessment

Mg/kg

Proposed Maximum level

Mg/kg or Mg/l

E 104

Quinoline yellow

Non-alcoholic flavoured drinks

100 mg/l 60 7

Candied fruits and vegetables, Mostarda di frutta

200 mg/kg 150 25

Preserves of red fruits 200 mg/kg 150 Proposed for deletion. Technological need is questioned.

Confectionery 300 mg/kg 250 30


level


evaluation)



assessment

Mg/kg


Mg/kg or Mg/l

Decorations and coatings

500 mg/kg 500 50

Fine bakery wares (e.g. viennoiserie, biscuits, cakes and wafers)

200 mg/kg 150 20

Edible ices 150 mg/kg 10 Proposed for deletion (not used any more according to Euroglace)

Flavoured processed cheese

100 mg/kg 0.004 0.004

Desserts including flavoured milk products

150 mg/kg 80 10

Sauces, seasonings (for example, curry powder, tandoori), pickles, relishes, chutney and piccalilli

500 mg/kg 80 0.02

Mustard 300 mg/kg 80 10

Fish paste and crustacean paste

100 mg/kg 100 Proposed for deletion. No quantitative use reported

Pre-cooked crustaceans 250 mg/kg 250 Proposed for deletion. No quantitative use reported

Salmon substitutes 500 mg/kg 500 Proposed for deletion. No quantitative use reported

Surimi 500 mg/kg 500 Proposed for deletion. No quantitative use


level


evaluation)



assessment

Mg/kg


Mg/kg or Mg/l

reported

Fish roe 300 mg/kg 300 Proposed for deletion. No quantitative use reported

Smoked fish 100 mg/kg 100 Proposed for deletion. No quantitative use reported

Snacks: extruded or expanded savoury snack products

200 mg/kg Proposed for deletion. Reformulation underway

Snacks: other savoury snack products and savoury coated nuts

100 mg/kg Proposed for deletion. Reformulation underway

Edible cheese rind and edible casings

Quantum satis 100 12

Complete formulae for weight control intended to replace total daily food intake or an individual meal

50 mg/kg 50 6

Complete formulae and nutritional supplements for use under medical supervision

50 mg/kg 50 6

Liquid food supplements / dietary integrators

100 mg/kg 100 12

Solid food supplements / dietary integrators

300 mg/kg 300 35

Soups 50 mg/kg 50 Proposed for deletion. Technological


level


evaluation)



assessment

Mg/kg


Mg/kg or Mg/l

need is questioned

Meat and fish analogues based on vegetable proteins

100 mg/kg 100 12

Spirituous beverages (including products <15% alcohol by volume) except those mentioned in Annex II or III

200 mg/l 180 40

Aromatized wines, aromatized wine based drinks and aromatized wine product cocktails as mentioned in Regulation (EEC) No 1601/91, except those mentioned in Annex II or III

200 mg/l 200 20

Fruit wine (still or sparkling); Cider (except cidre bouche) and perry; Aromatized fruit wines, cider, perry

200 mg/l” 200 20

Annex 5e

PROPOSED REVISION OF THE CONDITIONS OF USE OF PONCEAU 4R

Annex III

In the entry related to Americano, the reference to E124 Ponceau 4R is deleted and another entry is added

Americano E124 Ponceau 4R 10 mg/kg

In the entry related to Bitter soda, bitter vino as mentioned in Regulation (EEC) No 1601/91, the reference to E124 Ponceau 4R is deleted and another entry is added


E124 Ponceau 4R 10 mg/kg

In the entry related to Chorizo sausage and Salchichon, the existing provisions are deleted and replaced by the following:

Chorizo sausageSalchichon

E120 Cochineal, Carminic acid, Carmines

200 mg/kg

E 124 Ponceau 4R, Cochineal Red A

30 mg/kg

In the entry related to Sobrasada, the reference to E124 Ponceau 4R in the second column (Permitted colour) is deleted and another entry is added

Sobrasada E124 Ponceau 4R 22 mg/kg

In the entry related to jam, jellies and marmalades as mentioned in Directive 79/693/EEC and other similar fruit preparations including low calorie products, the entry to E 124 Ponceau 4R in the second column is deleted:


a) The food additive “E 124, ponceau 4R” mentioned in the list of Annex V, Part 2 to Directive 94/36/EC, shall be deleted from this list.


“Colour Foodstuffs Current Maximum

level


evaluation)

Maximum permitted use levels considered by EFSA when performing

the Tier 3 exposure assessment

Mg/kg


Mg/kg or Mg/l

E 124

Ponceau 4R


50 mg/l 50 6


200 mg/kg 200 22

Preserves of red fruits 200 mg/kg 200 Proposed for deletion. Reformulation reported under way



500 mg/kg 500 55

(also average of all ranges found in different surveys and other sources, FSA, FSAI, AFFSA, ELC, CIAA)


50 mg/kg 50 6



100 mg/kg 20 Proposed for deletion. Reformulation underway (source CIAA)


50 mg/kg 50 6

Sauces, seasonings (for example, curry powder, tandoori), pickles,

500 mg/kg 450 Proposed for deletion (reformulation


level


evaluation)



Mg/kg


Mg/kg or Mg/l

relishes, chutney and piccalilli

under way according to CIAA)






Surimi 500 mg/kg 500 Proposed for deletion. No quantitative use reported

Fish roe 300 mg/kg 300 Proposed for deletion. No quantitative use reported



200 mg/kg 70 Proposed for deletion. Reformulation underway



Edible cheese rind and Quantum satis 20 Proposed for


level


evaluation)



Mg/kg


Mg/kg or Mg/l

edible casings deletion. Reformulation underway


50 mg/kg 50 6


50 mg/kg 50 6


100 mg/kg 100 12


300 mg/kg 300 35

Soups 50 mg/kg 50 Proposed for deletion (no use reported). Reformulation reported under way

Meat and fish analogues based on vegetable proteins

100 mg/kg 100 12


200 mg/l 170 20

Aromatized wines, aromatized wine based drinks and aromatized wine product cocktails as mentioned in Regulation (EEC) No

200 mg/l 200 25


level


evaluation)



Mg/kg


Mg/kg or Mg/l

1601/91, except those mentioned in Annex II or III


200 mg/l” 1 1

Annex 5f

PROPOSED REVISION OF THE CONDITIONS OF USE OF SUNSET YELLOW

Annex III

In the entry related to Bitter soda, bitter vino as mentioned in Regulation (EEC) No 1601/91, the reference to E110 Sunset Yellow FCF/Orange Yellow S is deleted and another entry is added


E110 Sunset Yellow FCF Orange Yellow S

12 mg/kg

In the entry related to jam, jellies and marmalades as mentioned in Directive 79/693/EEC and other similar fruit preparations including low calorie products, the entry to E 110 sunset Yellow in the second column is deleted:

In the entry related to Sobrasada, the reference to E110 Sunset Yellow FCF in the second column (Permitted colour) is deleted and another entry is added

E110 Sunset Yellow FCF 15 mg/kg


a) The food additive “E 110, sunset yellow” mentioned in the list of Annex V, Part 2 to Directive 94/36/EC, shall be deleted from this list.



level


evaluation)

Maximum permitted use levels considered

by EFSA when performing the Tier 3 exposure assessment

Mg/kg


Mg/kg or Mg/l

E 110 sunset Yellow


50 mg/l 50 9


200 mg/kg 200 35

Preserves of red fruits 200 mg/kg 200 Technological justification questioned


level


evaluation)



Mg/kg


Mg/kg or Mg/l



500 mg/kg 200 35


50 mg/kg 50 8



100 mg/kg 0.02 Proposed for deletion. Reformulation underway


50 mg/kg 10 3

Sauces, seasonings (for example, curry powder, tandoori), pickles, relishes, chutney and piccalilli

500 mg/kg 450 Proposed for deletion (reformulation underway)






Surimi 500 mg/kg 500 Proposed for deletion. No quantitative use


level


evaluation)



Mg/kg


Mg/kg or Mg/l

reported

Fish roe 300 mg/kg 300 Proposed for deletion. Reported alternative found






Edible cheese rind and edible casings

Quantum satis 0.02 0.02


50 mg/kg 50 8


50 mg/kg 50 8


100 mg/kg 50 8


300 mg/kg 50 8

Soups 50 mg/kg 25 Proposed for deletion. Reformulation reported underway

Meat and fish analogues 100 mg/kg 100 20


level


evaluation)



Mg/kg


Mg/kg or Mg/l

based on vegetable proteins


200 mg/l 100 20

Aromatized wines, aromatized wine based drinks and aromatized wine product cocktails as mentioned in Regulation (EEC) No 1601/91, except those mentioned in Annex II or III

200 mg/l 200 40


200 mg/l” 1 1

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