Tag Archive for: CLP Regulation

Final OSHA Rule Published on Globally Harmonized System of Classification and Labeling of Chemicals

GHS/HazCom:

March 26, 2012, the Federal Register published OSHA’s final Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  With this rule OSHA has modified its Hazard Communication Standard (HCS) to be consistent with to the United Nations’ System. 

GHS Requirements

OSHA estimates that 880,000 hazardous chemicals are currently used in the U.S., and over 40 million employees are now potentially exposed to hazardous chemicals in over 5 million workplaces.  Approximately 75,000 firms create hazardous chemicals (i.e., products, substances, or mixtures) for which new labels and ‘safety data sheets’ (formerly material safety data sheets) will be required.

OSHA explains that implementation of the GHS will improve HCS by changing the performance requirements for labels to the GHS-specific requirements that labels include four standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s).  The appropriate label elements for a chemical are to be determined by the hazard classification.  Standardized label elements will better convey critically important hazard warnings, and provide useful information regarding precautionary measures that will serve to better protect employees than the performance-oriented approach of the current rule. 

Chemical manufacturers and importers will be required to re-evaluate chemicals according to the GHS criteria.  Chemicals must be classified based on the type and degree of hazards posed.  For health hazards, this will involve assigning the chemical both to the appropriate hazard category and subcategory (called hazard class).  For physical hazards new criteria are generally consistent with current DOT transportation requirements.  Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers will also be required. 

Jurisdiction

The rule adopts only sections of the GHS within the scope of OSHA jurisdiction.  DOT, CPSC and EPA will implement GHS at a later date.  EPA and OSHA have worked together to develop a common position on coverage of pesticides and chemicals.  The GHS will not require additional labels on pesticides labeled under EPA requirements; that is, the final products that enter into commerce.  However, OSHA GHS requirements will apply to the other chemical ingredients of pesticides; the ‘inactive’ ingredients or cleaning products that are hazardous.  This is a continuation of current OSHA HCS worker protection requirements.  OSHA anticipates that EPA will provide guidance to their regulated community on how to develop an OSHA GHS-compliant SDS to avoid conflict with pesticide labeling requirements. 

Key GHS Elements

Hazard communication.  A key goal of the final GHS is to better communicate hazard information to those most at risk—the workers exposed to hazardous chemicals Hazard communication requirements are provided in 29 CFR § 1910.1200.  Appendix C, Allocation of Label Elements, details how specified label elements apply to each hazard class and hazard category.  Appendix D, Safety Data Sheets, specifies requirements for the 16 SDS elements.

Concentration limits.  OSHA announced it will require the most protective GHS concentration limits for hazard classifications.  For example, for sensitizers and reproductive toxins, the final rule requires information to be provided on labels and safety data sheets at concentrations above 0.1%.  (See e.g., Appendix C, Allocation of Label Elements.)

Precautionary statements.  In addition to hazard statements, the GHS requires precautionary statements that describe recommended measures that should be taken to protect against hazardous exposures, or improper storage or handling of a chemical.  (See Appendix D, Safety Data Sheets).  Precautionary statements must also address hazard information necessary to protect workers from “hazards not otherwise classified that have been identified during the classification process.” (See Table D.1.)

Mixtures.  Health hazards posed by mixtures should be addressed based on the risks posed by the mixture itself, rather than by the hazards posed by the component chemicals individually.  The GHS does allow alternative classification methodologies where primary data are unavailable, including extrapolation and bridging.  The rule specifies procedures for determining whether mixtures are covered by the Standard. 

Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information.  New information about hazards and ways to protect against hazards must be added to the SDS within three months. 

OSHA has modified General Industry Standards containing hazard classification and communication provisions so that they will be internally consistent and aligned with the GHS modifications to the HCS. 

Implementation

Timeline.  Compliance with all of the provisions for preparation of new labels and safety data sheets is required by June 1, 2015.  Distributors will be allowed an additional six months to distribute containers received from chemical manufacturers and importers with the old labels and MSDSs in order to accommodate those they receive very close to the compliance date.  Workplace labels and training programs must be updated by June 1, 2016. 

State implementation.  OSHA intends to closely scrutinize amendments to previously approved State hazard communication standards to ensure equal or greater effectiveness, including assurance that any additional requirements do not conflict with, or adversely affect, the effectiveness of the national application of OSHA’s standard.

Guidance.  OSHA will be offering guidance materials such as quick cards and fact sheets to aid firms in developing and implementing the training requirements of this rule.  OSHA will also be releasing a small business compliance guide to provide additional guidance to small businesses, which will ease the economic impact and compliance burden. 

Next Steps

OSHA notes that the GHS is a living document, and the UN actively reviews it and considers possible changes based on implementation experiences and other information.  These changes are made on a two-year cycle, referred to as a biennium.  The OSHA proposal and the final rule are based on Revision 3 of the GHS.  OSHA will undertake future rulemaking as necessary to reflect new technological and scientific developments and UN revisions to GHS requirements.

Although not addressed in the rule, OSHA discusses interest in the development of a common classification database.  The European Union plan to deploy one.  Japan, Taiwan, South Korea, and New Zealand have already done so.  However, classifications in these databases are not necessarily the same for the same chemical.  OSHA would like an international database of classifications developed and maintained.  A UN Sub-committee has been established to explore the issue further. 

 

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

EU Environmental Law Group Releases Reports on Member State Implementation and Enforcement of REACh

REACh:

The EU public interest environmental law group, ClientEarth, recently released a series of progress reports summarizing Member State activities under the European Union (EU) regulation: Registration, Evaluation, and Authorisation of Chemicals (REACh).  Each report reviews a different Member State’s efforts to implement and enforce REACh.  Reports also are available for three non-Member State countries that have enacted REACh – Lichtenstein, Norway, and Iceland.

The reports are essentially responses to a lengthy questionnaire from the European Commission.  Activities reviewed include communications between Member State authorities and EU authorities, such as the European Chemicals Agency (ECHA); operation of the national helpdesks; development and promotion of alternative test methods; participation on REACH committees; evaluation of substances; preparation of Annex XV dossiers; and details concerning enforcement-related activities, such as inspections and the imposition of sanctions.  The reports may prove useful to companies wanting insight into the level and types of enforcement activity occurring within the countries regulating their operations.

ClientEarth received the reports through a public records request, insisting that their broad dissemination was necessary “so that [the public] can know if REACH is really working.” (Critics probably think they know the answer already.)  The reports are available here.

Consultation Periods Open on Proposals to Harmonize Classification and Labeling of Four Substances under the EU's CLP Regulation

EU CLP Regulation:

Public consultation periods have opened on propoosals to harmonize the classification and labeling of four substances under the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (the so-called “CLP Regulation,” (EC) No 1272/2008). The CLP Regulation implements the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (“GHS“). The substances are:  2-Ethoxyethanol (CAS No. 203-804-4); Reaction mass of 2,4,4-Trimethylpent-1-ene and 2,4,4-Trimethylpent-2-ene (CAS No. 246-690-9); Vinyl acetate (CAS No. 203.545-4); and Indoxacarb and Indoxacarb (enantiomeric reaction mass S:R 75:25 (Indoxocarb CAS No. 173584-44-6).   Copies of the proposals, and other details such as the deadlines for submitting comments, are available on the website of the European Chemicals Agency (“ECHA”).

If a proposal is accepted, the substance would be added to the list of harmonised classifications in Annex VI, part 3 of the CLP Regulation.  Thereafter, all manufacturers, importers and users of the substance in the EU would need to abide by the new harmonised classification and labelling.  Persons potentially affected may be interested in submitting comments.

Background on CLP Regulation and Harmonization

The so-called CLP Regulation entered into force on January 20, 2009.   The regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC).  Both directives will be repealed by June 1, 2015. 

Under the Regulation, individual EU Member States (“Competent Authorities” or “CAs”) and industry may propose harmonization of the classification and labelling of substances.  The decision on a particular classification for a substance or mixture is usually made by the supplier (“self-classification”).  However, in certain cases the decision on the classification of a substance is made at the Community level, which is then called “harmonized classification.”  A harmonized classification must be applied by default by the suppliers of the respective substance.

Hamonized classification and labeling may be approved:

  • when the substance is either:
    • carcinogenic;

    • mutagenic;

    • toxic for reproduction; and/or

    • a respiratory sensitiser;

  • when the substance is an active substance in a biocidal or plant protection products; or

  • when there is a need to harmonize a classification at EU level, as supported by a justification demonstrating the need for such action.

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Check back periodically for future postings on CLP developments.