Downstream Users

Waste fractions leaving the recycling process of waste as a recovered material have to fulfill the obligations of the REACH regulation, but with certain privileges. Article 2(7d) provides under certain conditions for an exemption from registration (Title II), downstream user regulations (Title V), and evaluation (Title VI) [10] ... 

REACH requirements for substances, mixtures, and articles do not apply to waste itself. Nevertheless manufacturers and importers of substances, downstream users and potentially recipients of articles have a number of duties under REACH related to substances in waste. Waste-related information must be included in the registration dossier for all substances, including those for which no CSR and/or SDS3 is required (<10 tla) or which are not classified as dangerous. [19]. 

Article 3(37) of REACH defines exposure scenarios as the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment [...] . 

A CSR is a risk assessment, following the general provisions of Annex I of the proposed REACH Regulation, with extra guidance in Annex IB for substances that are components of preparations. These general principles correspond with the current EU practice for notified new substances and priority existing substances, as described more fully in Section 14. The ECA will develop software to help registrants prepare the CSR. It is essential to have input from downstream users to prepare the risk assessment for the CSR, which... 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

Some companies are already using substitution as a means of eliminating hazardous chemicals from their businesses, (see Annex I) A variety of reasons exist for why some companies are searching for safer substitutes and these include regulatory drivers (such as the recent Directive on the Restriction of Hazardous Substances), increased public awareness, demands from downstream users or clients, worker protection, liability issues, competitive advantage and company ethics. However, there are also barriers and the development and adoption of safer substitutes is happening only slowly, in a piecemeal fashion and in some sectors not at all. 

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. ... 

A common complaint from downstream users of chemicals is that data gaps prevent adeguate characterisation of the risks from chemicals. Increased information under REACH will change this situation as long as data are transparent, readily available and accessible to the public. But collecting... 

Skanska are disappointed with the lack of a strong substitution rule in RE AC H "The present proposal is much more static, focusing only on evaluation and registration. Without the strong support from a Substitution Principle it will be difficult for an individual company that is a downstream user to be proactive In substituting substances." °... 

Market and actors Relevant actors (e.g. chemicals manufacturers and downstream users, enterprises, R D, organisations, state, seienee) and type of market (form and intensity of eompetition, Fordist/quality-differentiated B2B or B2C 3 = eonsumer market, supply or demand dominated) Who is predominant (the system leader) Who performs which role in the ehain What business volume is at stake What are the substance quantities What about imports/exports What are the market shares of the various solution options What is the relative eontribution offered by the partieular substanee to the overall eosts of eanying out the funetion ... 

Due to the split up stmcture of the sector with limited know-how of downstream users, the trade plays a key role in user information ( In small structured... 

Downstream users (i.e., producers and importers of products containing a given chemical substance) are brought into the system. 

REACH Article 1 states that this repfulation is based on the prineiple that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use sueh substances that do not adversely affect human health or the environment. This provision is one of the most essential innovations of REACH because manufacturers and importers now take the main responsibility for the valid information on safe use of the chemicals they... 

Manufacturers, importers, or downstream users usually classify and label chemicals under their own responsibility. This approach is called self-classification. It means that companies evaluate all available information concerning the intrinsic properties of a particular substance or mixture by applying to it the relevant classification criteria. However, since the available information or interpretation of data may differ from one company to another, each self-classification may result in a different classification and labeling for the same substance. From a regulatory point of view, classification and labeling discrepancies are problematic because they impede a consistent hazard communication on the chemicals market and may put at risk the appropriate protection of humans and the environment. 

The term substance of very hi h concern, abbreviated SVHC, is associated with a new process that was introduced to the European chemicals policy through the implementation of REACH the authorization process. This procedure aims (1) to encourage the substitution of substances of very high concern with less harmful substances or alternative technologies and (2) assure the proper control of risks arising from SVHC s. A substance being subject to authorization must principally not be used or placed on the market for any use within the European Union. However, specific uses of an authorized substance may be excluded from this general prohibition if, for example, they are a priori exempted from authorization or if the manufacturer, importer, or downstream user successfully applied for their authorization. The authorization process is laid down in REACH Articles 55-66 and may be initiated by the ECHA on behalf of the European Commission or by EU member state competent authorities. Substances which are subject... 

The Action Programme also demands to place "the responsibility on manufacturers, importers and downstream users for generating knowledge about all chemicals (duty of care) and assessing risks of their use, including in products, as well as recovery and disposal."... 

Exposure scenarios specify the conditions in which the chemical is to be used (including the protective equipment to be used, working practices, products it is incorporated into, how consumers use those products and how these are disposed), limiting the range of the conditions that must be considered in the exposure assessment. The exposure scenario is annexed to the chemical safety data sheet that is passed to downstream users of the chemical. Those downstream users are required to pass information back to their suppliers about their use of the substance, the exposure to the substance involved in that use and the practicality of specified risk reduction measures. If a use is significantly different from those identified in the CSA, the user must report this to the European Chemicals Agency and prepare its own CSA, or ask the manufacturer to revise the CSA to include that use. 

Under European chemicals legislation, proposals to restrict the production or use of chemicals, or to authorize the use of a chemical subject to the authorization procedures of REACH, are subject to a socio-economic analysis. The socio-economic analysis should include the following consideration of the commercial impacts on manufacturers, importers and downstream users the impacts on consumers the social impacts, such as effects on job security and employment the availability, suitability, technical and economic feasibility of alternative substances and/or technologies implications for trade, competition and economic development and the benefits for human health and the environment and the economic and social benefits of restrictions or refusal of authorizations (Regulation (EC) 1907/2006, Annex XVI). 

These prowsicns do not only affect Ihe chetnca) industry but also all downstream users, e g, the automotive, mechanical engineering, electronics, textile and construction industries. The vrpacts on the overall economy would be devastating, French and German studies do confirm this. 

The communication requirements of REACH ensure that manufacturers, importers, and their customers (i.e., downstream users and distributors) have the information they need to use chemicals safely. Information relating to health, safety and environmental properties, and risks and risk management measures is required to be passed both up and down the supply chain. The primary tool for information is the familiar safety data sheet (SDS) for all dangerous substances. 

A manufacturer, importer or downstream user must not place on the market any substance from the Annex XIII list unless its use has been authorised. 

The allocation of responsibilities for carrying out risk assessments of substances under the old system was also problematic, with the burden placed on public authorities rather than the enterprises that manufactured, imported or used the substances. Moreover, the risk assessments were required to be comprehensive rather than targeted and use-specific, resulting in a lengthy assessment process. By 2006, only 141 high-volume chemicals had been identified as priority substances for risk assessment. Information on uses of substances under the old system also tended to be incomplete, as only manufacturers and importers of chemicals were required to provide information, whereas downstream users (industrial users and formulators) were not, with only few exceptions. 

Once included in Annex XIV, the manufacturers, importers, and/or downstream users of the affected substance must request authorisation. The application is directly submitted to ECHA, which forwards the dossier to its Committee for Risk Assessment (CRA) and its Committee for Socio-Economic Analysis (CSEA) to produce a draft opinion within 10 months of submission. Applicants and interested third parties receive an opportunity to comment on the draft, whereafter the now finalised opinion is forwarded to the Commission, the Member States, and the applicant. The Commission then decides on the authorisation request following the regulatory committee procedure,27 which gives the Council veto power, but only in the rare instances where it can muster a qualified majority against the Commission measure.28... 

Once a substance is included in Annex XIV and the so-called sunset date has passed (Article 58),15 authorisation must be sought by any manufacturer, importer or downstream user wanting to use the substance or to place it on the market on its own, in preparations (above certain concentrations) or for incorporation into articles... 

Furthermore, REACH includes new or increased demands on the bidirectional flow of data and information in the supply chain (Tide IV) and places demands on downstream users (Tide V). For instance, REACH includes provisions on safety data sheets for substances on the candidate list (Article 31 and Annex II) and forces suppliers of articles to actively provide information for the safe use of the articles (Article 33). In addition, REACH entities consumers to, without charge, request information within 45 days on the safe use of articles containing SVHCs in concentrations above 0.1 wt% (Article 33). It remains to be seen to what extent the increased flows of information will impact on the management of chemicals. However, companies that work with environmental management systems and companies located closer to consumers in commodity chains will probably seek more actively to decrease chemical-related risks. 

The HCS, also known as the Employee Right-to-Know Law, is basically concerned with the exposure of workers to hazardous chemicals in the workplace. Under this standard, since 1986, all manufacturers, importers, and distributors of hazardous chemicals have had to label the containers they ship, listing the ingredients and hazards of the material in the containers, and provide Material Safety Data Sheets (MSDSs) to all downstream users, handlers, and storers of these chemicals. 

Step 1. We are assuming in this section that the product stream from the bottom of the stripper is set on the demand of a downstream user. The bottoms stream from the stripper is flow-controlled and so we set the position of the control valve, XMV(8), on this stream (B). The rest of the liquid level controls must be chosen to accommodate this first-priority choice. Note that we could put a flow controller on this stream if necessary, but this was not done in the simulations described later. The quality specification is that component G in the product should not vary more than 5 mol %. 

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