Positive List

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Considering the concerns of consumers for synthetic colorants and interest in natural formulas, many food manufacturers seek alternative healthy solutions to replace colorants, even the regulated ones from positive lists (like p-carotene), with colored fruit and vegetable extracts to be used as functional food ingredients or nutraceuticals (food supplements). ... 

In contrast to specifying to suppliers what chemicals or materials are restricted, it is useful to specify exactly what chemicals and materials are desired. Once a material or chemical is well characterized, and it is considered benign with respect to human and environmental health, it can be added to a preferred or positive list (i.e., P-list). For example, a textile manufacturer may source certified organic cotton, or polyester made with antimony-free catalysts, to develop a product line based on these fibres. Or a cleaning product formulator may seek bio-based solvents or rapidly biodegradable surfactants consistent with their product development objectives. 

U. SchOnhausen, Positive List I. Additives for Plastics, Elastomers and Synthetic Fibres for Food Contact Applications, Ciba-Geigy Ltd, Basel (1993). 

This evaluation is on the way. The different stakeholders have made their proposals regarding what should be modified or supplemented. Our proposals like improvement of transparency, installation of a positive list, and a household product database (HPDB) have been published some weeks ago, including the topic REACH and RISKCYCLE [14]. This article only covers the topic RISKCYCLE, but more in depth. 

The use of biocides is in Europe controlled and regulated by the EU Biocidal Products Directive [15]. Registration of a biocide is expensive and only a few active biocide substances will in the future be available for the leather industry in the EU. The directive will include a list of active substances that are permitted to use by the leather industry (a so-called positive list). Many eco-labels and RSL does already today include restrictions of the use of some biocides. 

Two percentage cost sharing rates, depending on the type of pharmaceuticals involved. Some pharmaceuticals are free, while others are excluded from pubhc coverage Percentage rates of sharing in the cost of pharmaceutical consumption. Positive list of pharmaceuticals with pubhc coverage... 

Unlike negative and positive lists, RP does not restrict the list of available medicines for the prescriber and the patient. If the doctor prescribes a product with a price higher than RP, the patient pays the difference but there is no additional co-payment if EFP is equal to or lower than RP. 

The British approach is to allow any ingredient that is not poisonous unless the ingredient is banned. Additives are regulated by a positive list approach. Unless the substance is on the permitted list it can not be used. There are anomalies where a substance can be legal in foods but not be permitted to be described in a particular way. An example is the... 

IR interpretation can be as simple or as complicated as you d like to make it. You ve already seen how to distinguish alcohols from ketones by correlation of the positions and intensities of various peaks in your spectrum with positions listed in IR tables or correlation tables. This is a fairly standard procedure and is probably covered very well in your textbook. The things that are not in your text are... 

This powerpoint presentation reviews food-contact regulations worldwide with reference to current systems for regulating food-contact materials. These include general safety requirements, licensing/registration, mandatory and voluntary positive lists, no objection letters, and combinations of the above and their applicability to various countries. 

Related on-going work on evaluation of >2000 flavourings for positive list... 

The regulation contains details of the procedure for drawing up a positive list of flavouring substances. Member states must first notify the Commission of a... 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

Under the BPD, the biocidal substances are evaluated centrally by the EU Commission. The evaluation is based upon a very extensive data package submitted by the biocide substance manufacturer including a risk assessment of the use of the biocide in AF products. The outcome of the evaluation by the Commission is to decide whether the biocide is prone to be included in a positive list, also termed Annex I, or not. 

Methodically devised and established methods (and criteria) of substance and process assessment and evaluation like risk analysis, toxicological and ecotoxi-cological analyses, life-cycle-analysis and cost-benefit analysis . But also much simpler approaches, which in practice play an important role for assessing formulations and snbstance properties (e.g. the nse of negative and/or positive lists). 

The Directive requires an authorization process for biocidal products containing active substances listed in positive lists (Annexes I, lA, and IB of the Directive 98/8/EC). In relation to biocides, existing active substances are substances, which have been on the EU Market for biocidal purposes before 14 May 2000. An active substance, which was not on the market before 14 May 2000 is regarded as a new active substance and has to be approved by the Member States before it will be entered on the positive hsts. 

The notification procedure of existing active substances, which had started in 2000, was finalized on 31 January 2003. After having succeeded the notification procedure, the names of existing active substances have been published in the Official Journal of the European Communities (OJ). At the next step, the full dossier including aU test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance. At the last step, the Rapporteur Member State in cooperation with all other Member States will decide whether the active substance wUl be entered onto the positive lists or not. 

According to the Directive, an active substance cannot be used in a PPP unless it is included in an EU positive list. The Directive also requires very extensive risk assessments for effects on health and environment to be carried out, before a PPP can be placed on the market and used. In 1992, the European Commission started a Community-wide review process for aU active substances used in PPPs within the EU. Based on scientific assessments, each applicant had to prove that a substance could be used safely regarding human health, the environment, ecotoxicology and residues in the food chain. This program will be completed by 2008. From the end of 2003, the European Food Safety Authority (EFSA) deals with risk assessment issues and the European Commission retains the risk... 

Article 6 Deals with Limited Lists (Positive lists)... 

Producers/notifiers and Competent Authorities defining the data and studies required for the inclusion of an active substance onto one of the positive lists (Annexes IIA and IIIA). 

Competent Authorities defining criteria for the inclusion of active substances onto one of the positive lists. 

By the published Directive 1999/2/EC, the European commission was charged to develop a final positive list of permitted items until the end of 2000, but the contents of this list are not yet published. There was even a consultation on this problem on the Internet and industry and consumer organizations responded [130]. As long as the positive list is not adopted. Member States can maintain the existing regulations except for spices [131]. 

Comments on the DG SANCO Consultation of Consumer Organizations, Industry Concerned and Other Interested Parties on the Strategy for Completion of the Positive List of Food and Food Ingredients to be Authorised for Irradiation Treatment, Annex of Directive 1999/3/EC, SANCO/4175/2000-rev.l, European Commission, Health and Consumer Protection Directorate-General, Directorate D - Food Safety Production and Distribution Chain, Brussels, 2000. Ehlermann, D.A.E. Radiat. Phys. Chem. 2002, 63, Til. 

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