Specific legislation

Additional considerations, e.g. relating to labelling, information supply, emergency procedures, arise when marketing and transporting chemicals. While — as with Chapter 11 and with control measures generally — what is required will vary with specific legislation, basic requirements are summarized in Chapter 12. 

Excipients should be listed in the composition using their Ph Eur name (or one from another national pharmacopeia from an EEA member state), the International Nonproprietary Name, or an exact scientific designation, other than for materials such as preservatives or coloring agents which can be identified by an E-number. Third country pharmacopeial names may be acceptable. Coloring matter is subject to the provisions of specific legislation in the EEA. 

At the member state level, some countries, such as the Netherlands, a pioneer in the protection of soil, have their own national policies and regulations for the management of contaminated soils that were adopted before the Soil Framework Directive [132], Protection guidelines vary from country to country, and specific legislation for soil contamination only exists for some member states, including the Netherlands, Italy, Austria, France, Belgium, Germany, the UK, Denmark, Spain and Finland [128],... 

In Table 36 specific legislation is listed primarily concerning organic pigments. 

The FDA s authority to regulate drugs derives from specific legislation (Table 5-2). If a drug has not been shown through adequately controlled testing to be "safe and effective" for a specific use, it cannot be marketed in interstate commerce for this use. ... 

Below I describe the development of European legislation from 1967 to the late 1990s and contrast some of the principles embedded in it with those contained in some product-specific legislation. I then give an account of REACH and the debates surrounding it. 

Fig. 16.2 General chemicals law and examples of sector specific legislation...

Under REACH, chemicals will also continue to be restricted, banned or authorised under several pieces of different legislation, including product-specific legislation such as the Toys Directive, Construction... 

All authorisations granted are general authorisations. This means everybody may use a substance authorised. There exists also the possibility to authorise the use of substances, materials or processes only for the individual petitioner. Authorised substances are listed in specific Community legislation. The Framework Regulation contains a list of materials for which specific legislation may be adopted. This list comprises 17 different materials. Only a few are yet covered by specific Community legislation (see sections 3.4 and 3.5). 

System of no specific legislation but industry code of practice defining due diligence of the business operators this system is applied in the UK. 

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. 

No specific legislation exists in the EU for adhesives but all food contact materials must comply with the Framework Regulation (EC) 1935/2004 (see Chapter 3). Adhesives are described in Commission Directive 2002/16/ EC on the use of certain epoxy derivatives. In the absence of specific harmonised rules then the Practical Guide states that National Legislation should be considered. National legislation exists in Germany (BfR Empfehlungen XXVIII Components of adhesives) and in Slovenia. ... 

Multi-layer packaging which includes materials other than plastics, e.g., metals and paper, even if the food contact layer or part of the food contact layer consists of plastic, is currently not covered by any specific legislation. These multi-layer materials are regulated either by national legislation or by Article 3 of the Framework Regulation (EC 2004). Article 3 states that... 

In the absence of specific legislation for the other (non-plastic) food contact materials used in take-away and snack food packaging then the plastics legislation is used as a guide, although limits are not taken as presumptive standards. Where possible, in the absence of specific migration limits (SMLs), levels found are related back to exposure restrictions such as tolerable daily intake (TDl) or acceptable daily intake (ADI). 

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