Services

REGULATORY REVIEW

LHAMA Certification for ASTM D-4236

An EMI art materials review for compliance with ASTM D-4236 using the guidelines outlined in Code of Federal Regulations (CFR) Chapter 16 1500.135 affords a thorough and comprehensive analysis.

While some competitors only provide a formula evaluation for chronic hazards with no physical or chemical considerations in their analysis, EMI offers a full complement of analytics and certifications.

• LHAMA certification and FHSA review
• Consumer product labeling
• This list published by the Office of Environmental Health Hazard Assessment has grown to include over 900 chemicals since it was first published in 1987.
• Provide expert testimony and representation with regulatory agencies

LHAMA Certification continues »

Toxicological Risk Assessment

The following provides, by market, the scope of an EMI Toxicological Risk Assessment.

United States

Standard TRA

EMI's standard TRA utilizes the Code of Federal Regulations (CFR) guidelines for product hazard classification, specifically toxicity, irritancy, corrosiveness and sensitization.

EMI prepares TRAs for many industries and applications.

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GHS SDS Authoring

The GHS is an acronym for The Globally Harmonized System of Classification and Labeling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labeling of chemicals. It is a logical and comprehensive approach to:

• Defining health, physical and environmental hazards of chemicals;
• Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and
• Communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS).

General Certificate of Conformity (GCC)

Manufacturers and importers of certain general use products (i.e., non-children's products) for which consumer product safety rules apply, must certify, in a written General Certificate of Conformity (GCC) based on testing or a reasonable testing program, that their products comply with those applicable rules.

Children's Product Certificate (CPC)

Certification means the issuance of a written Children's Product Certificate (CPC) in which the manufacturer or importer certifies that its children's product complies with all applicable children's product safety rules (or similar rules, bans, standards, or regulations under any law enforced by the Commission for that product.)

Certification of children's products must be based upon the passing test results of third party testing. The third party testing laboratory provides the testing services and results but does not issue the children's product certificate. The manufacturer or importer is responsible for drafting and issuing the CPC.

PRODUCT STEWARDSHIP AND HEALTH & SAFETY REVIEW

For organizations that lack either the resources or the desire, EMI, with its comprehensive skill set and global resources, will assume any or all of the responsibilities necessary to successfully shepherd a client company's product through the regulatory process to ensure compliance and assure required labeling and safety.

Product stewardship and health & safety review services include:

• Document preparation and technical reports concerning chemicals, metals, plastics and polymer additives and their major health implications for the general population as well as occupational environments.
• Safety Data Sheet (SDS) preparation in 16–part GHS format.
• Toxicity evaluation by in vivo and in vitro methods are applied for consumer products, industrial chemicals and mixtures of environmental pollutants Testing may include immediate and delayed toxic effects, reproductive and genetic effects, and evaluation of potential health risk.

PROCESS GUIDANCE FOR ART MATERIAL

EMI's extensive knowledge in the area of consumer product as well as art and craft materials composition can prevent client missteps in the formulation process. Such missteps prior to seeking certification can be costly and time consuming.

Should safety issues arise from a product formulation, specific labeling may be necessary. EMI possesses the process acumen that can eliminate the necessity for such labeling by recommending an alteration of base ingredients.

Issues can also arise during the production process resulting in a variety of needless costs due to production disruption, expanded insurance requirements and/or worker health issues. EMI can analyze a production process to reduce unnecessary and costly process issues.

Process guidance for art materials services includes:

• Pre-Manufacturing Notice (PMNs) Application as required by the Toxic Substance Control Act (TSCA)
• EPA Registration of new chemical substances (risk assessment, chemical process review TSCA chemical inventory searches, both confidential and non-confidential inventory) and document submission.

EXPERT TESTIMONY

For a broad spectrum of situations including environmental, occupational and consumer product, EMI provides expert deposition and trial testimony for litigation support concerning alleged routes of exposure or alleged adverse health effects. EMI litigation support can take the form of position papers and reports as well as interpretation of complex medical issues and conditions. EMI can, also, identify and coordinate a team of experts relevant for a specific case.

Expert testimony services include:

• Litigation support for cases involving chemically-induced, adverse health effects. Support includes position papers, interpretation of complex medical issues and conditions, aid to attorneys with witness preparation as well as expert witness depositions and assistance in securing qualified experts.
• Scientific literature searches and summary evaluations of pertinent citations using in-house data bases as well as university library resources and national data base services.