Manufacture and Import

Chapter 4 - Classification and Labelling - Manufacturers or importers of a polymer have a duty to classify and label the polymer before placing it on the market. Manufacturers or importers that place a polymer on the market must also make a notification to the classification and labelling inventory at the European Chemicals Agency (ECHA). Manufacturers or importers of a polymer have a duty to classify monomer substances that they are registering as part of the technical dossier. This chapter describes what needs to be done to classify the chemicals used and how to label them. This chapter also explains who needs to do the labelling and classification, and how any health hazards are to be dealt with in the labelling. 

Chapter 6 - Communication in the Supply Chain - this chapter is divided in two sections The first section is dedicated to the description of general communication 

This book will be useful to anyone who works with polymers or the chemicals that are used to make polymers, whether they are end-users or suppliers. REACH is affecting everyone concerned with the polymer industry and this book will help them to prepare for the impact and consequences of the REACH legislation. 

This Chapter describes key scientific principles and technologies associated with the polymer industry with respect to the obligations and requirements established under the EU legislation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 

Polymers are important materials in modern society. From medical devices to construction products, polymers are used by end-users in practically every manufacturing sector. 

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Regulatory changes and discussions of the impact of regulations on the manufacture and import of cosmetic products are available in manuals pubhshed by the CTFA (9). 

Title IV Manufacture and imports Tide IV Manufacture and importation... 

European Regulations Veterinary Medicines Directive 2001/82/EC o Title IV Manufacture and imports o Title VII Pharmacovigilance o Title VIII Supervision and sanctions. 

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]. 

Before a new substance is first marketed, the placer on the market , i.e. manufacturer and importer, has to notify it and to present proof that not risk arises from the use of this substance. In Germany the Notification Unit of the Federal Institute for Occupational Health and safety (FIOSH) receives the relevant data. 

In accordance with EEC ordinance no. 793/93 (existing substances ordinance) dated 1993, manufacturers and importers have to submit the available data for every substance listed in EINECS to the European Chemicals Bureau (ECB), if their production volume or import volume was in excess of 10 t/a in a predefined reference period. All in all, the industry has submitted data covering the basic data set of European chemicals legislation in only 14% of cases for high-volume existing substances (2500 substances > 1000 t/a) . Details concerning exposure were even more patchy. 

US-EPA classifies chemical substances as either existing chemicals or new chemicals. US-EPA repeatedly screens these chemicals and can require reporting or testing of those that may pose an environmental or human health hazard. US-EPA can ban the manufacture and import of those chemicals that pose an unreasonable risk. 

In 1998, US-EPA s Administrator invited the Chief Executive Officers of more than 900 chemical companies that account for most of the U.S. manufacture and import of HPV chemicals to participate in the HPV Challenge Program. The program encourages chemical manufacturers to voluntarily test chemicals for which little or no health or environmental effects data were publicly available. 

Registration requires manufacturers and importers of chemicals to obtain relevant information on their substances and to use that data to manage them safely. 

In the absence of any approved official standard, procedures for quality control, overseas manufacture and importation were tenuous to the extent that it was often unclear as to whether some fireworks were suitable for sale to the general public or whether they should be used by a licensed importer or manufacturer. 

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... 

Assessments of risks are, of course, only as good as the information on which they are based. For new substances, information had to be supplied before a chemical could be marketed. This was not the case for existing substances. Under the Existing Substances Regulation (Regulation (EEC) 793/93) manufacturers or importers of more than 10 tonnes per year of a substance listed in the inventory had to supply information on that substance to the European Commission, and as the amount they manufacture or import increased so did the data requirements. Manufacturers and importers had to make all reasonable efforts to obtain data... 

TSCA chemical information rules manufacturers and importers must submit a Preliminary Assessment Information Manufacturers Report for each site at which they manufacture or import each substance by the reporting date shown... 

Recent regulatory developments at state, national and international level suggest that certification of products, according to their emissions, is expected to become mandatory across much of the developed world for building materials and related products. This will affect both manufacturers and importers. 

For example, once implemented, the European Commission s new chemicals policy REACH (Registration, Evaluation and Authorization of Chemicals) -endorsed in 2003 - would require manufacturers and importers of over one ton per year of any chemical substance to gather information on the properties, hazards, and use of that substance, and submit the data to the European Chemicals Agency. The Agency would then determine if the chemical substance needed to be further regulated, restricted, or banned from use. It is estimated that about 30,000 existing chemicals produced in or imported into Europe would be subject to REACH. Key objectives of the European Commission s initiative on the reformulation of chemicals policy are to raise human and environmental safety levels as well as to simplify and standardize the current legislation. 

Treaty of Versailles. Article 171 The use of asphyxiating, poisonous or other gases and all analogous liquids, materials or devices being prohibited, their manufacture and importation are strictly forbidden in Germany. ... 

After the 2003 amendment to the law, it became mandatory for manufacturers and importers to report hazard information that they gathered on the properties of chemical substances they handle. Several schemes were also introduced to this law at that time. They include the following ... 

Publication of the name and notified volume of substances whose total manufacturing and import volume is 11 or more... 

Manufacturers and importers of substances in quantities over 1 tonne will have to submit a... 

Substances that have been proved to be toxic to humans and/or the ecosystem (including ozone-depleting substances) and have spread widely in the environment (substances manufactured and imported in an amount of 100 tonnes or more per year and detected in two or more places in the environment)... 

Substances which are as toxic as class I designated chemical substances, but to which humans and the environment are not so much exposed as class I designated chemical substances (substance manufactured and imported in an amount of 1 tonne/year or more and detected in only one place in the environment). 

Manufacturers and importers of surfactants must also be aware of a number of other regulations that impact the commerce of chemicals in the US. This section will briefly describe the requirements of the Occupational Safety and Health Act (OSHA), administered by the... 

MSDS - Material Safety Data Sheets (now usually referred to as SDS, Safety Data Sheets) Suppliers, manufacturers and importers who make up the chain of supply of essential oils to the aromatherapist, and ultimately the client, are responsible for drawing up the MSDS. Each time an oil is repackaged or relabelled, a MSDS should be prepared and relevant additional... 

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. 

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