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Lycopene approved as a food ingredient in the EU
F O C US Agency under the terms of the REACH legislation on health and safety monitoring of chemical substances in widespread use. (See ‘Focus on Pigments’, Jan 2006, 1-3). The detailed application for registration was filed by a consortium, led by Evonik Degussa. At this stage, a registration number has been issued to Evonik Degussa only. But this facilitates the procedure for other members of the consortium who now need only to supply their respective supplementary details in order to receive registration numbers for their carbon black products. Besides Evonik Degussa, the carbon black consortium consists of: Cabot Corp, Timcal Belgium SA, Continental Carbon Co, Cancarb Ltd, Columbian Chemicals Co, and Sid Richardson Carbon & Energy Co. European Rubber Journal, Jul/Aug 2009, 191 (4), 11
Scope of EU’s permitted food colorants list now covers medicinal products Under Directive 94/36/EC, ratified by the European Parliament & Council on 30 June 1994, a single list was established for colorants authorised for use in food and beverage products manufactured and traded within the European Union. Annex 95/45/EC was ratified on 26 July 1995, setting out the quality criteria for food colorants, including the maximum permitted levels of certain trace impurities. From time to time, in the light of new scientific evidence and product developments, the list of permitted colorants is modified. However, until recently, there was no single EU-wide list of colorants authorised for use in medicinal and pharmaceutical products. Indeed, there were some notable disparities between different countries, with a particular colorant being permitted in one EU country but prohibited in another. The European Commission accepted research findings showing that there is no reason on health grounds why colorants permitted for foodstuffs should not also be permitted for medicinal and pharmaceutical products. This led to the adoption of Directive 2009/35/EC, ratified by the European Parliament & Council on 23 April 2009, whereby the list of colorants permitted for food and beverage products (together with the annex on
OCTOBER 2009
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purity criteria) will be applied on the same basis to medicinal and pharmaceutical products throughout the European Union. Official Journal of the European Communities L Legislation, 30 Apr 2009, 52 (L109), 10-13, (Website: http://europa.eu.int/eur-lex/lex/en/index.htm)
Lycopene approved as a food ingredient in the EU In response to separate requests from a number of companies, the European Commission has authorised the use of lycopene throughout the EU as a novel food ingredient, serving as a colorant and as an antioxidant. The decision was issued on 28 April 2009, with lycopene being added to the list of approved food ingredients covered by Regulation EC/258/97. DSM Nutritional Products Ltd (of Kaiseraugst, Switzerland) filed an application in Ireland on 18 July 2008, seeking approval of the use of “synthetic lycopene” as a food ingredient, apparently without specifying any particular source or method of processing. Two earlier requests from other companies had been rather more specific. In October 2003, Vitatene (of Leon, Spain) filed an application for the use of lycopene as a food ingredient, where the lycopene was derived from Blakeslea trispora (a fungal plant pathogen). In September 2004, Ottaway & Associates (quality and environmental consultants, based in London) filed for approval of lycopene oleoresin, derived from tomatoes, as produced by LycoRed Ltd (of BeerSheva, Israel). The application was challenged (presumably by competitor food colorant suppliers) and this led to an examination of the safety and efficacy of lycopene by the European Food Safety Authority (EFSA). The EFSA published its findings on 24 April 2008, with the conclusion that lycopene can be safely used as a food ingredient. The EFSA also reported that the average user’s consumption of lycopene should be below the acceptable daily intake, though it is possible that some (extreme) users may consume more than the acceptable daily intake.
Against that background, the European Commission decided that it would be appropriate to draw up a list of food products acceptable for having lycopene as an ingredient. The Commission will collate data on consumer intake levels of lycopene, especially in breakfast cereals, following authorisation of its use as a novel food ingredient, so as to be able to review safety data by 2014, if not before. DSM, Vitatene and LycoRed will be required to supply data as part of the Commission’s monitoring programme. Official Journal of the European Communities L Legislation, 30 Apr 2009, 52 (L109), 47-51 & 52 (L110), 54-57, (Website: http://europa.eu.int/eurlex/lex/en/index.htm)
CORRECTIONS 10% drop in global industrial output The collapse of Lehman Brothers in September 2008 triggered widespread concern about toxic debts and the frailty of major financial institutions. Banks became ultracautious about lending and the ‘credit crunch’ led inexorably to a general downturn in demand. All the world’s major pigment suppliers experienced savage cuts in revenues and profits during the first six months of this year. In the text, we correctly quoted BASF’s forecast reduction in total global industrial output at 10% for fullyear 2009. That is the figure, ie minus 10%, which should have appeared in the accompanying table. Focus on Pigments, Sep 2009, 4
DIC sales at nearly Yen 1000 bn DIC (of Tokyo) claims a 25% global market share in organic pigments and a 30% global market share in printing inks. As we correctly reported, these two businesses are part of DIC’s Graphic Arts segment, which contributes just over 60% of the group’s revenue. For the year to endMarch 2009, the segment’s sales were Yen 574.6 bn (about $5.7 bn). But total DIC revenue was Yen 932.3 bn – not the figure shown in the accompanying table. Focus on Pigments, Jul 2009, 7
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Scope of EU’s permitted food colorants list now covers medicinal products Under Directive 94/36/EC, ratified by the European Parliament & Council on 30 June 1994, a single list was established for colorants authorised for use in food and beverage products manufactured and traded within the European Union. Annex 95/45/EC was ratified on 26 July 1995, setting out the quality criteria for food colorants, including the maximum permitted levels of certain trace impurities. From time to time, in the light of new scientific evidence and product developments, the list of permitted colorants is modified. However, until recently, there was no single EU-wide list of colorants authorised for use in medicinal and pharmaceutical products. Indeed, there were some notable disparities between different countries, with a particular colorant being permitted in one EU country but prohibited in another. The European Commission accepted research findings showing that there is no reason on health grounds why colorants permitted for foodstuffs should not also be permitted for medicinal and pharmaceutical products. This led to the adoption of Directive 2009/35/EC, ratified by the European Parliament & Council on 23 April 2009, whereby the list of colorants permitted for food and beverage products (together with the annex on
OCTOBER 2009
O N
PIGMENTS
purity criteria) will be applied on the same basis to medicinal and pharmaceutical products throughout the European Union. Official Journal of the European Communities L Legislation, 30 Apr 2009, 52 (L109), 10-13, (Website: http://europa.eu.int/eur-lex/lex/en/index.htm)
Lycopene approved as a food ingredient in the EU In response to separate requests from a number of companies, the European Commission has authorised the use of lycopene throughout the EU as a novel food ingredient, serving as a colorant and as an antioxidant. The decision was issued on 28 April 2009, with lycopene being added to the list of approved food ingredients covered by Regulation EC/258/97. DSM Nutritional Products Ltd (of Kaiseraugst, Switzerland) filed an application in Ireland on 18 July 2008, seeking approval of the use of “synthetic lycopene” as a food ingredient, apparently without specifying any particular source or method of processing. Two earlier requests from other companies had been rather more specific. In October 2003, Vitatene (of Leon, Spain) filed an application for the use of lycopene as a food ingredient, where the lycopene was derived from Blakeslea trispora (a fungal plant pathogen). In September 2004, Ottaway & Associates (quality and environmental consultants, based in London) filed for approval of lycopene oleoresin, derived from tomatoes, as produced by LycoRed Ltd (of BeerSheva, Israel). The application was challenged (presumably by competitor food colorant suppliers) and this led to an examination of the safety and efficacy of lycopene by the European Food Safety Authority (EFSA). The EFSA published its findings on 24 April 2008, with the conclusion that lycopene can be safely used as a food ingredient. The EFSA also reported that the average user’s consumption of lycopene should be below the acceptable daily intake, though it is possible that some (extreme) users may consume more than the acceptable daily intake.
Against that background, the European Commission decided that it would be appropriate to draw up a list of food products acceptable for having lycopene as an ingredient. The Commission will collate data on consumer intake levels of lycopene, especially in breakfast cereals, following authorisation of its use as a novel food ingredient, so as to be able to review safety data by 2014, if not before. DSM, Vitatene and LycoRed will be required to supply data as part of the Commission’s monitoring programme. Official Journal of the European Communities L Legislation, 30 Apr 2009, 52 (L109), 47-51 & 52 (L110), 54-57, (Website: http://europa.eu.int/eurlex/lex/en/index.htm)
CORRECTIONS 10% drop in global industrial output The collapse of Lehman Brothers in September 2008 triggered widespread concern about toxic debts and the frailty of major financial institutions. Banks became ultracautious about lending and the ‘credit crunch’ led inexorably to a general downturn in demand. All the world’s major pigment suppliers experienced savage cuts in revenues and profits during the first six months of this year. In the text, we correctly quoted BASF’s forecast reduction in total global industrial output at 10% for fullyear 2009. That is the figure, ie minus 10%, which should have appeared in the accompanying table. Focus on Pigments, Sep 2009, 4
DIC sales at nearly Yen 1000 bn DIC (of Tokyo) claims a 25% global market share in organic pigments and a 30% global market share in printing inks. As we correctly reported, these two businesses are part of DIC’s Graphic Arts segment, which contributes just over 60% of the group’s revenue. For the year to endMarch 2009, the segment’s sales were Yen 574.6 bn (about $5.7 bn). But total DIC revenue was Yen 932.3 bn – not the figure shown in the accompanying table. Focus on Pigments, Jul 2009, 7
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