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.

Maximum Residue Levels MRL for Pesticides - New EU Rules

Recently, new European Union (EU) rules setting enforceable Maximum Residue Levels (MRLs) for pesticides came into force (Regulation No 396 / 2005). Rules set Maximum Residue Concentrations (MRL) for a wide range of pesticide in a variety of agricultural products. The MRLs are listed in a publicly available database. A European Commission database is now available to search for the MRL applicable to each crop and pesticide.

Caltha LLP assists companies in meeting various product stewardship requirements and meeting regulatory standards. Caltha staff provide specialized expertise in the assessment of chemicals, including agrichemicals, in the environment.

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

Battery Recycling Requirements - New European Union Rules

New EU-wide rules to boost the collection and recycling of used domestic batteries came into force recently. The rules are intended to reduce the environmental and health hazards posed by mercury, lead, cadmium and other metals in batteries.

The targets, agreed by EU member states, are the collection of 25 % of discarded household batteries by 2012. This target will rise to 45 % in 2016.

By September 26, 2009 all batteries collected should be recycled, with exceptions in certain circumstances. Batteries containing mercury, lead and cadmium are classified in Europe as "hazardous waste". The new rules also cover industrial and vehicle batteries, ensuring that users have the possibility of returning used batteries for collection. The new rules also include restrictions on the use of mercury in all batteries and on the use of cadmium in portable batteries.

Caltha LLP assists manufacturers in meeting product stewardship goals and regulatory requirements associated with their products.

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

EU Proposes Revision To WEEE Directive

The Waste Electronics and Electric Equipment (WEEE) Directive came into force in 2003. Soon after a number of technical, legal and administrative difficulties became apparent; therefore the WEEE Directive was thus called out for up-date and simplification.

The WEEE Directive aims to 1) prevent the generation of electrical and electronic waste and 2) to promote reuse, recycling and other forms of recovery to reduce the quantity of waste discarded. It requires the collection of waste electrical and electronic equipment and the recovery and reuse or recycling of waste collected.

The directive is based on producer responsibility; producers of equipment used by private households are responsible for providing financing for the collection, treatment, recovery and environmentally-sound disposal of WEEE deposited at collection facilities. Producers of equipment used by others than private households are financially responsible for the costs of collection, treatment, recovery and environmentally-sound disposal.

Member States are required to draw up a register of producers and collect information on an annual basis on the quantities and categories of electrical and electronic equipment placed on their market, collected, re-used, recycled and recovered within that Member State and on collected waste exported.

Since 2003 data have shown that the Directive's goals could not be achieved at current collection and recycling rates. An EU review of the Directive required the Commission to propose new mandatory WEEE collection target and new targets for recovery and re-use or recycling, including for reusing whole appliances as appropriate, and targets for electrical and electronic medical devices. A new provision is added to harmonize producer registration and reporting in the EU by making national registers inter-operable.

Experience with the WEEE Directive also points to implementation problems resulting in a high percentage of WEEE not handled according to the requirements of the directive. It also shows that a significant amount of illegal shipments of polluting E-waste finds its way to developing countries where is has an impact on the health of local populations. To close the implementation gap, the EU proposes to strengthen the enforcement of the WEEE Directive.

Caltha LLP assists manufacturers in meeting their product stewardship goals and regulatory requirements.

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

EU Regulation 396/2005 – Maximum Residue Levels MRL for Pesticides

Recently, new European Union (EU) rules setting enforceable Maximum Residue Levels (MRLs) for pesticides came into force (Regulation No 396 / 2005). Rules set Maximum Reside Concentrations (MRL) for a wide range of pesticide in a variety of agricultural products. The MRLs are listed in a publicly available database. A European Commission database is now available to search for the MRL applicable to each crop and pesticide.

Caltha LLP assists companies in meeting various product stewardship requirements and meeting regulatory standards.

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