It's A Small World - Chemical legislation is becoming something of a hot topic around the world; in addition to Europe, many other countries, such as the U.S., Canada, China, Japan, South Korea, Malaysia, Taiwan, Turkey and Switzerland are currently either developing new or amending their current chemicals legislation. There are similarities between the different legislative instruments but essentially each country or region is developing their legislation to meet local requirements. Grasping the nettle of harmonization now would have benefited everyone in the supply chain but as it stands companies will have to ensure that they monitor developments in each country closely to ensure compliance.

Reach and CLP (Classification, Labelling and Packaging of Chemicals) are being phased-in in a series of discrete steps until 2018, when the main requirements defined in the process will essentially be complete. The CLP regulation is the European implementation of the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals developed under the guidance of the United Nations but, in the European version, some parts have been left out and others added to achieve the original objective of harmonizing without lowering the current level of protection of human health and the environment. The regulations are not only being introduced in the 27 EU Member States but, because of the legal framework in Europe, also in the three additional states that signed up to the European Economic Area Agreement - Iceland, Liechtenstein and Norway. In addition, membership of the EU is not static and a number of other countries, such as Croatia, Macedonia and Turkey, have recently applied to join, so they may also apply in these countries at some stage in the future.

Why New Regulations?
The regulatory authorities believed that the new legislation was necessary because the previous EU legislative framework for handling chemicals was inadequate. It was 40 years old and a complex mixture of different directives and regulations. In spite of being continuously updated, there were many anomalies. These include the lack of information about the effects of the majority of existing chemicals on human health and the environment; and different rules for "existing" and "new" chemicals, which the authorities believed hampered research and innovation, causing the EU chemicals industry to lag behind its counterparts in the rest of the world.
In addressing these concerns, especially those related to exposure to the chemical substances used, the authorities decided to broaden the scope of the legislation to not only cover chemical substances and mixtures but also include articles. This decision placed a number of many new responsibilities on chemical manufacturers and importers into Europe. While some of the responsibilities were not particularly onerous, some were new; some weren't actually new but involved changes to the information supplied because the legislation had changed; and some were new to companies simply because they had not been impacted by the legislation associated with chemicals before.
Supplier responsibilities often vary with the industry concerned. Some are voluntary, like the completion of customer questionnaires confirming the compliance status of products; others are obligatory, like describing the use of the chemical substance, supplying the safety data sheet and label for hazardous products, and informing customers when the products they receive contain more than a threshold amount of certain specific hazardous substances. This is in addition to the need to supply certain specific information to the European Chemicals Agency (ECHA) and ensuring that your suppliers have also fulfilled all their responsibilities.

Fulfilling Multiple Roles
Deciding what information has to be supplied is well defined in the legislation but varies with the role assumed by the company. What is often forgotten is that a company may fulfil multiple roles. Sometimes they will be supplying the chemical substance or mixture and the information but other times they will be purchasing the chemicals from another company which means they will mostly receive information. It is critical that the different roles, as defined in the legislation, are assigned accurately and the information, received and distributed, is stored for reference purposes. Another key factor to consider is where the companies are based, because this could also impact on both the role and the responsibilities under the Reach and CLP Regulations. Typically, if the supplier and the customer are both based inside the EU, then the responsibilities will remain with the supplier. However, where the supplier is based outside the EU, the customer must be cautious; otherwise they could inherit the responsibilities from their supplier.

Classification Of Articles
In practical terms, customers seldom want to have all the details but are looking for reassurance that their suppliers have everything under control and that the products they are currently using will continue to be available in the future. The information required involves understanding the type of product supplied, i.e., is it a chemical substance or a chemical mixture and, if it is an article, the supplier needs to identify which type of article it is. The four different types of articles are all defined in the legislation, and companies must determine the product type to identify current and future requirements. The classification of articles is less intuitive because, in the search for clarity, the number of different types has increased.

Example 1 - Chemical Company A, based in the EU, supplies a hazardous chemical substance to Chemical Company B, also based in the EU, for use in their process.

• The supplier may have to reassure the customer that the chemical substance has been pre-registered, and, where necessary, will be registered at the appropriate time under the Reach regulation and also, where necessary, be notified at the appropriate time under the CLP Regulation with ECHA.
• The supplier will have to label the product correctly and supply a safety data sheet to the customer in the correct format. It is worth noting that the format of the safety data sheet will soon change, and the information on the label and in the safety data sheet may also change.
• The supplier may have to complete a chemical safety assessment (CSA) and ensure that the information in the safety data sheet supplied to the customer is consistent with that contained in the CSA.
• The customer may have to inform the supplier of the use made of the chemical substance in his process and implement the risk management measures given in the safety data sheet.

Example 2 - Chemical Company A, based in the EU, supplies a non-hazardous chemical mixture to Chemical Company B, also based in the EU for use in their process.

• The supplier may have to reassure the customer that all the chemical substances present in the mixture have been pre-registered, and, where necessary, may have to be registered at the appropriate time under the Reach regulation, and may also, where necessary, have to be notified to ECHA at the appropriate time under the CLP regulation.
• The supplier will have to label the product correctly and, where necessary, supply a safety data sheet (SDS) to the customer and the conditions, when this is applicable, are listed in Article 31 of the Reach regulation. Should a SDS not be required, then certain information must still be supplied and the requirements are all listed in Article 32 of the Reach regulation.
  
• The supplier may have to complete a chemical safety assessment (CSA) and ensure that the information in the SDS supplied to the customer is consistent with that contained in the CSA.
  
• The customer may choose to inform the supplier of the use made of the chemical mixture in the process and consider implementing any risk management measures recommended in the safety data sheet. 

Example 3 - Chemical Company A, based in the EU, supplies a non-hazardous chemical mixture to Company C, also based in the EU, for use in the manufacture of an article.

• The supplier may have to reassure the customer that all the chemical substances present in the mixture have been pre-registered, and, where necessary, may have to be registered at the appropriate time under the Reach regulation, and may also have to be notified to ECHA at the appropriate time under the CLP regulation.
• The supplier will have to label the product correctly and, where necessary, supply a SDS to the customer and the conditions, when this is applicable, are listed in Article 31 of the Reach regulation. Should a SDS not be required, certain information must still be supplied and the requirements are all listed in Article 32 of the Reach regulation.
• The supplier may have to complete a CSA and ensure that the information in the safety data sheet supplied to the customer is consistent with that contained in the CSA.
• The supplier must inform the customer of the presence of any Substances of Very High Concern (SVHCs) present in the mixture.
• The customer may choose to inform the supplier of the use made of the chemical mixture in his process and consider implementing any risk management measures recommended in the safety data sheet.
• The supplier must inform the customer of the presence of any SVHCs present in the mixture so the amount present in the article can be determined.

By choosing to base all the companies in the EU the above examples are rather simple and may not be either representative or typical. Supply chains and markets are, in the most part, far more complicated because most companies either source raw materials or manufacture products globally. In practice, it is rare for a company to source all the raw materials inside the EU as well as selling the finished product locally. This adds a level of complexity when determining compliance and requires an in-depth understanding of how a company operates in order to determine what information has to be distributed within the supply chain.

Summary
The implementation of the Reach and CLP regulations in Europe has placed new responsibilities on the manufacturers and importers of chemical substances, mixtures and articles. While these new responsibilities may not be particularly onerous, many are new and have to be complied with if companies wish to continue placing their products on the European market. The search for clarity by the regulatory authorities, especially with articles, has caused confusion because the process is now less intuitive, but companies are working diligently to ensure that the data required is collected and communicated along the supply chain.