REACH, ROHS, Prop 65 and Other Chemical Compliance Certifications

Caltha LLP Project Summary

Project: Certification of REACH, ROHS, Prop 65, Conflict Minerals, Biocidal Products Compliance
Client: Component Manufacturer 
Location(s): Minnesota

Key Elements: EU Chemical Regulations, California Proposition 65 Labeling, Conflict Minerals Compliance Certifiaction

Overview: Caltha LLP was retained by this component manufacturer to compile compliance documentation and to prepare Certification of Compliance. Certification of compliance was required by customers who purchased manufactured components and incorporated them into their final products which were exported to the European Union and other areas.

Caltha prepared a certification form and background information to be completed by raw material suppliers that allowed each supplier to provide an informed certification statement regarding presence/absence of regulated chemical substances, and if present, documentation that concentrations are below regulatory thresholds.

OSHA GHS Hazard Communication Final Rule Expected In August 2011

The U.S. Occupational Safety and Health Administration (OSHA) has released their timetable on the adoption of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) into the federal hazard communication standards. After a long rulemaking process, which began with an Advanced Notice of Proposed Rulemaking in September 2006, a Final Rule is expected to be completed in August 2011.

The current OSHA hazard communication standard used in the United States is not consistent internationally and can cause complications when dealing with international trade. Adoption of the GHS into federal requirements will allow US manufacturers, employers and employees to use a hazard communication system that is more recognizable worldwide. Several countries, including the European Union, have already adopted the GHS, with varying implementation schedules.

[Read a Regulatory Briefing on the proposed GHS standard]

Caltha LLP provides specialized expertise to clients nationwide in the evaluation environmental rules, developing EH&S compliance procedures, and preparing cost-effective EH&S management programs.

For further information contact Caltha LLP at info@calthacompany.com or Caltha LLP Website

EU REACH Directive - Chemical Users Responsibilities

Although the burden of risk evaluation and control is placed on the manufacturers and importers, REACH does include requirements that apply to USERS of regulated materials. The risk assessment process used to register materials is based on specific uses and mitigations. Therefore, the User requirements assure that mitigation measures are actually used, and that any new uses of materials, which were not included in the risk assessment, are evaluated.

To accomplish this, Users are required to

• Use materials only for labeled uses
• Understand and use all risk mitigation measures incorporated into the manufacturers risk analysis
  

If Users of materials wish to have new uses, they have two options available:

1. They can inform their manufacturer or supplier of the new uses and request that the new uses be added to the list of recognized uses (which may require further risk assessment)
2. They can perform and submit their own risk assessment on the new use

For further information contact Caltha LLP at
info@calthacompany.com
or
Caltha LLP Website

EU REACH Directive - Basic Requirements

REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States.

Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations. This article provides a summary of some of the key elements and concepts of the REACH Directive.

The basic format for the REACH directive is:

• All chemicals manufactured and/or imported to the EU in volumes more than 1 ton per year are required to be registered
• All registered chemicals must identify uses
• Manufacturers and importers must assess the risks associated with the manufacture and uses of chemicals, and then report findings to a central agency, the European Chemicals Agency.
• The European Chemicals Agency will be responsible for reviewing and evaluating chemical information and determining if any further actions to control risks are appropriate.
  

If chemicals or mixtures contain chemicals of very high concern (carcinogens, mutagens, etc.), then specific authorizations and/or restrictions on the manufacture, import, and/or uses of the materials may be required.

For further information contact Caltha LLP at
info@calthacompany.com
or
Caltha LLP Website

Manufacturer Requirements under EU REACH Directive

Much of the REACH Directive details requirements placed on manufacturers and importers of chemicals. In summary, unlike past regulations, REACH places the burden of proof regarding potential risks of chemicals on the manufacturers and importers.

For all regulated materials, manufacturers/importers will be required to prepare an assessment of risks to human health and the environment associated with the identified uses of the subject material. Therefore, to accomplish this, manufacturers/importers will first need to identify the uses of the material. Then, based on the recognized uses, exposure scenarios and risk assessment can be completed. At this point, manufacturers can recommend procedures for use, pollution prevention practices, personal protective measures, or other measures to mitigate the risks associated with the recognized uses.

The European Chemicals Agency will review the risk information submitted. The agency will determine if further mitigations are required, or if more broad restrictions need to be developed.

For further information contact Caltha LLP at
info@calthacompany.com
or
Caltha LLP Website

REACH Directive - Assessing Existing Chemicals Under REACH

Unlike the previous regulations, REACH applies to ALL chemicals currently used or sold in the EU. Existing chemicals, as of 1981, were exempted from the previous regulations; since then only new chemicals were required to have risk evaluations conducted.

All existing chemicals, previously exempted, will now have to go through the same risk evaluation. During the next several years, risk evaluations will be required from manufacturers and/or importers on a phased-in basis.

The REACH Directive does offer partial or full exemptions for certain materials:

R&D Uses. To prevent the Directive from unnecessarily hampering R&D developments, substances used in product- or process-development do not need to be registered for up to 5-years

Special Uses. Some special use chemicals, especially related to Food and Medical Products Sectors, have different requirements

Currently, about 30,000 chemicals are thought to be used in the EU at volumes greater than 1 ton/year. About 16% of these have come into the market since 1981 and have been regulated as “new” chemicals and were evaluated using the previous regulatory framework. Therefore, about 84% of the materials currently being used in the EU will require assessment for chemical risks.

For further information contact Caltha LLP at
info@calthacompany.com
or
Caltha LLP Website