Recently, an EMPF customer called to discuss the REACH Directive for parts being shipped to EU countries. The customer was concerned if they had to register with the EU since the parts were not directly marketed in the EU countries, but they have downstream customers who use their product in EU countries.

In June 2007, the European Union (EU) System on Registration, Evaluation, Authorization and Restrictions of Chemicals (REACH) entered into force. This new legislation substantially rewrites the current EU chemicals policy and introduces new legal obligations for the industry.

Not only chemical producers, but also downstream users of chemicals and producers of finished products are heavily impacted. Companies importing products to the EU market will have to comply with the same strict requirements as the EU companies.

Registration or authorization is a precondition to access the EU market. Ability to provide REACH compliant products will be decisive for choosing a supplier. You may gain a competitive advantage if you start preparing for compliance now.

REACH shifts the burden to industry, such that all actors in the supply chain are obliged to ensure the safety of the chemical substances they handle. The registration process requires that manufacturers and importers generate data for some 30,000 chemical substances produced or imported into the EU above one ton per year. This data should be filed in a registration dossier, which should be submitted to the European Chemicals Agency (ECHA).

For substances of very high concern, authorization will be necessary. These substances will be prioritized and, over time, included in Annex XIV. Once they are included, industry will have to submit applications to the Commission for authorization on continued use of these substances. In addition, EU authorities may impose restrictions on the manufacture, use, or placing on the market of substances causing an unacceptable risk to human health or the environment. Safety Data Sheets must be provided to downstream users by manufacturers and importers to inform them about the potential risks of the concerning substance.

The European Chemicals Agency is in charge of the day-to-day management of REACH.


Substances exempt from REACH

Some substances are exempted from REACH: radioactive substances, wastes, substances under customs supervision, and substances necessary for the interests of defense.
Chemical substances used to manufacture other chemical substances that are never separated from the mixture of other chemicals inside a closed system, are fully exempt from REACH (as non-isolated intermediates). Intermediates that are separated during the production process (as isolated intermediates) must be registered, but with simplified information requirements commensurate with their lower risk.


Substances exempt from Registration

Some substances are exempted from Registration. Substances occurring in nature, such as minerals, ores and ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, process gases and components thereof, crude oil, coal, and coke are not required to be registered as long as they are not chemically modified. In addition, a number of basic substances for which the hazards and risks are well known are also exempted: hydrogen, oxygen, several noble gases (argon, helium, neon, xenon), and nitrogen.

There are also exemptions from large parts of REACH for substances in food, medicinal products, and plant protection because those are
regulated in specific legislation.

Polymers are, for the time being, also exempted from registration and evaluation. However, monomers must be registered.Nanomaterials are included in the scope of REACH and should be registered and authorized.


How does REACH affect your company?

• Your company may be affected not only as a producer, importer of chemicals, but also as an importer of finished products to the EU market and downstream user of chemicals.
• Each individual case should be carefully assessed. You may be the importer for one substance and a downstream user for another.
  
• Assessing impact is a company specific issue; your situation is not the same as your competitor.
  
• No data, no market! Registration or authorization is a precondition to sell on the EU market.
  
• Ability to provide REACH compliant products will be decisive for choosing a supplier.

What information should be submitted?

The registration dossier should include:

     Technical dossier

• Physicochemical, toxicological, ecotoxicological properties of substances
• Intended uses, human and environmental exposure
  
• Classification and labeling
  
• Proposed risk management measures, testing
  

     Chemical safety report

• If >10 ton/year: human health, environment, exposure hazard assessment, risk characterization

Timeline for registration

The deadline for registration is the same for substances on their own, in preparations, and in articles. They depend on:

• The volume of the substance produced or imported per year
• Substances classified below should be registered by 2010
  • CMRs (Carcinogens, Mutagens and substances toxic to Reproduction) >1ton/year
    
  • vPvBs (very Persistent and very Bioaccumulative substance)
    
  • R50-53 >100ton/year
    
    • R-Phrases (short for Risk Phrases) are defined in
      Annex III of European Union Directive 67/548/EEC: Nature of special risks attributed to dangerous
      substances and preparations.
      R50: Very toxic to aquatic organisms
      R51: Toxic to aquatic organisms
      R52: Harmful to aquatic organisms
      R53: May cause long-term adverse effects
      in the aquatic environment

If the substances you are producing or importing are classified as CMRs, PBTs, or vPvBs and are included in Annex XIV, you must ask for an authorization for your specific use. The request for authorization should be sent to the Commission.


Authorization dossier should include:

• Chemical safety report
  
• Analysis of the alternatives considering their risks and the technical and economic feasibility of substitution
  
• Research and development activities by the applicant
• Substitution plan including a timetable for proposed actions by the applicant
  
  

Authorization dossier may include:

• Socio-economic analysis
  
• Justification for not considering risks to human health and the environment arising either from emissions or discharges
  
• The European Commission grants authorization assisted by the Agency and a Committee
  
  

Authorization of use is granted if:

• Risk to health and environment is controlled, including discharges, emissions, and losses
  
• Socio-economic benefits outweigh risk and no suitable substitutes available
  

Authorization is time limited and subject to review. Exemptions of use are granted if EU legislation provides for requirements and management measures related to heath and environmental protection, and risk
is controlled.


Reporting

Under REACH, certain information should be communicated to your suppliers, customers, and public authorities.


     Reporting to suppliers

• Your company has the right to make use known to supplier of substances
  
• You have the obligation to identify exposure scenarios and measures to control risks
  
  

     Reporting to customers

• Safety Data Sheets are to be submitted to your customer
  
• You must inform your customers of the presence of Hazardous Substances contained in a concentration > 0.1% by weight, even if the total annual volume is less than 1 ton/year

     Reporting to authorities

• The European Chemicals Agency
  
• The Commission
  
• Member States Authorities

Your company has the obligation to keep and update information.

For more information on REACH Directives, or other classes available from the EMPF, including IPC certifications, please contact the registrar at 610.362.1295 or via email at registrar@empf.org. Course descriptions can be found on the web at www.aciusa.org/courses.