The substitution principle

An entry of an active substance in Annex I, lA or IB may be refused or removed, if the evaluation of the active substance shows that under normal use conditions risks to health or the environment still give rise to concern, and if there is another active substance on Annex I for the same product type available, which presents significantly less risks to health or to the environment. 

But it has to be taken into account that the alternative active substance can be used with similar effects on the target organism without economic and practical disadvantages for the user and without an increased risk for health and for the environment. 

The assessment shall be carried out under the following conditions  

The decision to remove an Annex I entry shall be delayed for a period up to a maximum of four years from the date of the decision. 

The data protection provisions are contained in Article 12 of the Directive. The purpose of data protection provisions is to allow applicants who have supported the inclusion of active substances in Annex or lA of the Directive (alone or as part of a consortia) to recover some of the costs of generating the data. Therefore many Member States only use the information referred to in Article 8 for the benefit of a second or subsequent applicant if this applicant has access to the data or the data protection has expired for the data. 

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The most important step towards a preventive regime, one that truly has protection of human health and the environment at its core, is to give a central place in chemicals legislation to the Substitution Principle. This can be defined quite simply as the substitution of hazardous substances by less hazardous, or preferably non-hazardous, alternatives where such alternatives are available. It means that if a product that uses a hazardous chemical can be manufactured using a safer alternative, at a reasonable cost, the hazardous substance will no longer be permitted for that use. Common sense Yes, but currently things do not work that way, and many hazardous substances are used without need, simply because there is no legislative or economic reason for substitution to take place systematically. 

Eorthis reason, the Substitution Principle cannot be implemented to its full and necessary effect simply as a general policy statement within the regulatory framework, since this will be an insufficient driver for change. Instead it needs a clear mandatory imperative to drive it. Within REACH, this means that the Substitution Principle needs to be written into the authorisation procedure so that the availability of a safer alternative is sufficient grounds for an authorisation to be refused. 

An alternative may be safer in that it does not meet the criteria for very high concern, but it may have other hazards such as corrosivity or flammability. These hazards are easier to control, but if there is a serious health and safety issue with a proposed substitute, that alternative would not be deemed an available alternative. A proposal for a workable authorisation procedure based on the Substitution Principle is shown schematically in Figure 1. 

As a basis for protection of human health and the environment from chemicals of concern, the Substitution Principle has several advantages ... 

It implements the Precautionary Principle. Arguments against the Precautionary Principle commonly centre on what degree of evidence of harm is necessary before action is taken to restrict the use of a substance. When applying the Substitution Principle, it is not necessary to wait for cancers, reproductive disorders or genetic defects and elusive evidence of cause and effect. If alternatives with less hazardous intrinsic properties are available, use of the hazardous substance is not permitted. The potential for harm is then reduced or avoided altogether. 

Many progressive companies have used the Substitution Principle to move towards the goal of clean production. Some downstream users of chemicals claim to only use benign chemicals in their processes and products. For instance, the McDonough Braungart team of consultants has worked with the Design Tex company to produce a carpet that is made with non-hazardous chemicals from their Positive chemical list. ... 

SAFERCHEMICALS WITHIN REACH Using the Substitution Principle to drive Green Chemistry... 

The Substitution Principle must be an obligation for all - not only for the most progressive companies... 

The acceptance of the Substitution Principle as a workable legal act was demonstrated in a European Court of Justice (ECJ) court case in 2000. Trichloroethylene (TRI), a cancer-causing chemical, was banned in Sweden and companies had to find alternatives. Exemptions were only given when a suitable alternative was not available, when use did not lead to unacceptable exposure and on the condition that the company continued to seek alternatives. Forthe majority of exemptions, the firms had managed to substitute TRI in most of their production, but had not found a suitable alternative for a specific use in the production process. One firm appealed against the ban, but the European Court of Justice ruled against them. The ECJ ruling demonstrates acceptance of the Substitution Principle in EU courts. 

Companies with experience in working systematically with substitution are in many cases actively promoting the inclusion of the principle in legislation. This is, for instance, seen in comments from companies to the European Commission during the REACH consultation in July 2003. Notably, companies with lengthy experience from national requirements embracing the substitution principle praise the legislative instrument, and promote its use in REACH. 

The Substitution Principle should be the key principle of the authorisation process. Specifically, it must be mandated that the... 

Skanska is one of the world s largest construction companies and was ranked by the Financial Times as the world s most respected company in the property and construction sector. Skanska Sweden was a leader in developing a national, industry-wide chemical database. The Skanska database now contains over 5,000 chemical products and stipulates if a substance is banned from use, should be avoided or represents an environmentally favourable choice. This positive approach, based on the substitution principle, prevents the company being stifled by the prohibition of a substance, since existing alternatives are instantly presented. 

Although the application of the Substitution Principle is not specifically ruled in this directive, substitution follows from the principle of avoidance as required through paragraph 4(2) (a) and paragraph 4.2(b) (iii). In all cars produced and placed on the market by 1 July 2003, lead, mercury, cadmium or hexavalent chromium must be replaced by othersubstances, with the exemption of those substances listed in Annex II... 

Juiy 2000 Those requirements— are compatible with in Case C- the Substitution Principle which emerges... 

Through the mentioning in the preamble, the Parliament and the Council establish substitution as a guiding principle forthe directive. Given that the substances that are covered by this directive are well researched and evaluated (Preamble 7), both entities aim at protecting human and animal health as well as the environmentally sound recovery and disposal of electrical and electronic waste with the application of the Substitution Principle (Article 1). 

As the EU has signed the texts below, it has thereby committed itself to the principles established in those conventions (such as the Substitution Principle) and their implementation in an EU context as well. 

The Substitution Principle is closely tied to the general goal of elimination, which is manifested in Article 5. A direct consequence of the employment of the Substitution Principle is the application of best Available Technologies (BAT) and Best Environmental Practice (BEP) when dealing with unintentional sources as classified in Annex C. BAT as such also requires the use of less hazardous substances. (Annex C, part V, (A (b)) again refers to the Substitution Principle demanding in para (d) the replacement of feed materials which are POPs or where there is a direct link between the materials and releases of POPs from the source and consequently health effects and harm for humans and the environment. 

The Substitution Principle is one of the guiding principles of the OSPAR Strategy. In this function, the Substitution Principle continues to play an important role with regard to the implementation of the Strategy (Paragraph 5.5) where the application of the principle as a means of implementation requires the substitution of hazardous substances. Preferably non-hazardous substances should be selected over less-hazardous when replacing a substance. 

PCB polychlorinated biphenyls, TBT tributyl tin, CFC chlorofluorocarbons Cf e.g. the substitution principle in the German Ordinance on Hazardous Substances ( 16 and 36). Please refer to Technical Rules for Hazardous Substances TRGS 440 for the recommended procedure of substitution. 

However, exclusively regulation-driven substitution of hazardous substances does not work. Approaches based on general regulations, e.g. the substitution principle contained in the Ordinance on Hazardous Substances, are unable to take action up to the level of small and medium-sized enterprises or crafts users due to structure-related deficits in enforcement. This means that additional driving forces are needed. However, the legally established obhgation of industrial or commer-... 

The Substitution Principle is a fundamental provision of the Ordinance on Chemical Products issued pursuant to the Act on Chemical Products of f985J24 25... 

Failure to follow the substitution principle to prevent damages to humans or to the environment may carry shffpenalties. In cases of severe negligence, large fines can be levied, and violators can be subject to up to two years imprisonment28... 

Companies would need to apply the substitution principle under the Chemical Agents Directive when selecting substances identified as meeting the criteria safe or permissible uses. 

Safer Chemicals Within Reach Using the Substitution Principle to Drive Green Chemistry, REACH Report prepared for the Greenpeace Environmental Trust by Clean Production Action, Clean Production Action, 2004. www. cleanproduction. org/library/SafeChem.pdf. 

Extending the substitution principle under the German Hazardous Substances Ordinance (i.e., the EC Chemical Agents Directive) to cover environmental risks. 

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