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.

pic-evaluationWhile 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
  • Compliance with California Proposition 65 as well as applicable state art labeling codes
  • 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.

Toxicological Risk Assessment continues »

 

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

pic-stewardshipFor 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

pic-process-guidanceEMI’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

pic-expert-testimonyFor 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.

“Great communication, very open to requests for customized service, excellent turn-around times, fair pricing. I am much more than satisfied. I recommend EMI at every opportunity. And then there are the people... I always feel like I am amongst friends in your company.”

Mr. Ben Gavett
Director of Safety Compliance
Golden Artist Colors, Inc.

Glossary of Standards and Regulations
ASTM D-4236 ASTM International, formerly American Society for Testing and Materials, is an organization that sets standards accepted around that world for manufacturing and materials, products and processes, systems and services. ASTM D-4236 Standard Practice for Labeling and Chronic Health Hazards is the set of standards established for labeling art materials for known chronic health hazards. The designation "conforms to ASTM D-4236" means all of the potentially chronic hazards of the art product have been clearly labeled on the product packaging including, among them, safe handling instructions, sensitizing components, information sources, labeling contents and product size.
LHAMA LHAMA is an acronym for the Labeling of Hazardous Art Materials Act. A LHAMA certification requires the use of the ASTM D-4236 standards for art materials labeling for a wide interpretation of all artists' materials manufactured for any kind of art or craft including work done by children that is sold in the United States.
Proposition 65 (P65) In 1986, California voters approved the Safe Drinking Water and Toxic Enforcement Act of 1986, otherwise known as Proposition 65. P65 requires the State of California to publish and update a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list published by the Office of Environmental Health Hazard Assessment has grown to include approximately 800 chemicals since it was first published in 1987. P65 requires businesses to notify Californians about significant amounts of listed hazardous chemicals in any of the company’s products manufactured, sold or shipped in California. EMI equips manufacturers with a sophisticated resource that can conduct a comprehensive review of a product formula to assess if any component is on the P65 list. If a component on the list presents a significant risk, EMI would provide the label information the product would require. Should the product manufacturer wish to challenge the requirement by the state of California, it can call upon EMI and EMI's world renowned toxicologist Dr. Rudolph J. Jaeger, DABT, ERT to conduct a risk assessment. The risk assessment explores if, based on the intended use, the product in question does not require a P65 warning. EMI can also explore the possibility of replacing the listed ingredient with a suggested alternative ingredient not on the P65 list.
Expert Testimony In any situation requiring expert testimony such as a P65 challenge, EMI’s Dr. Rudolph J. Jaeger DABT, ERT can be retained to provide expert testimony.
REACH REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a regulation of the European Union, that aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. REACH Regulation places responsibility on industry to manage the risks from chemicals and to provide safety information on the substances.
RoHS R0HS (Restriction of Hazardous Substances) originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products.