Positive list substances

Currently, for additives, there is an incomplete list existing because the harmonised evaluation of all additives is not yet finalised. It is to be noted that for manufacturing food contact plastics, only positive list substances are allowed as additives [6]. 

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. 

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... 

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... 

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... 

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. 

Following article 5 of the EU Flavour Directive, EU Regulation 2232/96 defined the basic rules for the use of flavouring substances for foodstuffs in the EU. In addition, it lays down a procedure for establishing a positive list for flavouring substances in the EU [7]. 

In 1998 the EU Commission within the Commission Decision 199/217/EEC published an inventory of flavouring substances used in the EU. This inventory (including its amendments) lists most of the flavouring substances which are subject to evaluation, leading to a positive list of flavouring substances to be used in foodstuffs in the EU [8]. 

Regarding artificial flavouring substances, four EU member states (Germany, Italy, Spain and the Netherlands) have specific positive lists with use levels, whereas all other EU member states permit all artificial flavouring substances suitable for human consumption. 

Positive list of authorised substances (114 substances 72 compounds and 42 groups of substances)... 

Only for monoethylene glycol (MEG) and diethylene glycol (DEG), which under certain circumstances can be transferred in unacceptably high quantities, have migration limits in food been provided for in Directive 86/388/EEC. The positive list has been amended on two occasions (Directives 86/388/EEC and 92/15/EEC) and the Commission took the opportunity of a third amendment (Directive 93/10/EEC) to codify all the directives adopted. Now the positive list contains 72 compounds and 42 groups of substances, i.e. 114 chemical products. 

As regards monomers, the list is complete and contains 206 substances or groups of substances. Accordingly, it rules out the use of an unlisted monomer at the Community level (positive list). Member States may, however, authorise the use of monomers which appear in Section B of Directive 90/128/EEC until 31 December 2001 (78 sub-... 

Amphetamine and cannabinoids can also be detected in routine analyses together with cocaine and opiates. As the frequency of positive findings is relatively low compared to the frequency of positive urine results, it may be assumed that amphetamine and cannabinoids will only be detected after regular consumption. Positive findings of THC can be confirmed by the detection of THC-COOH and OH-THC to exclude the possibility that the hair had only been contaminated by smoke. MDMA, MDE, and MDA can be detected in hair, but there is little experience with quantitative results. In routine analysis on illegal drugs, all listed substances in Figure 8 should be taken into consideration. 

The completion of harmonisation of rules for plastic food contact materials and articles is within sight. The finalisation of the positive list for authorised additives is likely to happen in 2008. In 2007 the Commission will, besides the Community list of authorised additives, publish a list of additives authorised at national level for which a valid application for EU authorisation has been made to EES A. Only these substances may be used until evaluation is finalised by EES A and a decision on authorisahon is taken by the European Commission. Another project in the plastics sector is the extension of the rules to multimaterial multilayer structures where the plastic layer is in contact with the food. At this moment only plastic materials which consist entirely of plastic are covered by the plastics Directive. These materials, when they are made up from layers of plastic, constitute only about 15% of the mutilayer market. Other multilayer materials such as beverage cartons, which consist of a food contact layer of plastic and aluminium and/or paper, are not yet covered by specific legislation. Extension of the plastics mles to these materials will have to take into consideration requirements for the non-plastic layers and establish mles for migration testing of these materials. 

The toxicological characteristics of substances on the EU positive lists for chemical migrants are normally obtained through time-consuming and... 

H., 2005, Non-targeted multi-component analytical surveillance of plastic food contact materials Identification of substances not included in EU positive lists and their risk assessment, Food Additives and Contaminants, 22, 1012-1022. 

EU legislation covering plastics food contact materials is well advanced with a positive list for monomers complete and a positive list for additives near completion. Decisions on how other substances used in plastics, such as aids to polymerisation and colourants are to be regulated, if at all, have yet to be made. Plastics used in contact with food must comply with the Framework Regulation, which lays down the basic rules ... 

The legislation of some European countries comprises positive lists for artificial flavouring substances, such as ethyl vanillin. 

After the completion of the safety evaluation of the above mentioned flavour compounds, the current register will be transferred into the European positive list of flavouring substances, comprising natural, nature-identical and artificial molecules. The status will not be indicated in the foreseen list. As a consequence, the currently existing positive lists for artificial compounds on the level of country-specific legislation will then be obsolete. 

This regulation will end in a positive list of flavouring substances to be used in foodstuffs in a stepwise procedure as follows According to Article 3 the Member States had to notify to the Commission a list of the flavouring substances which may be used in foodstuffs marketed on their territory. On the basis of the notification the... 

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