TRA Toxicology Risk Assessment and LHAMA Art Material Labeling Method Q&A

What are TRA and LHAMA?

TRA (Toxicological Risk Assessment): A systematic scientific assessment process used to determine the risk level of potential adverse effects on human health from chemical components in a product under normal and reasonably foreseeable exposure conditions. It is based on a comprehensive analysis of product ingredients, exposure levels, and toxicological data to draw conclusions and propose risk management recommendations.

LHAMA (Art Material Labeling Act): A federal regulation in the United States aimed at protecting artists, students, and children from chronic health hazards caused by harmful substances when using art materials. The regulations require that art materials undergo a chronic toxicity risk assessment and provide a declaration of "Conforms to ASTM D4236" and necessary warning information on the packaging.

What are the core differences and connections between TRA and LHAMA?

difference:

1. Different nature: TRA is an evaluation process and method, while LHAMA is a specific regulatory requirement.

2. Different scope of application: TRA has a wide range of applications and is suitable for various consumer goods such as cosmetics, toys, stationery, etc; LHAMA specializes in art materials.  

3. Different outputs: TRA outputs a risk assessment report; LHAMA outputs labels that comply with regulatory requirements.

Contact:

The core foundation of LHAMA compliance is to conduct a thorough TRA. TRA is a necessary scientific tool and prerequisite for achieving LHAMA compliance.

Which products require TRA? Which products must comply with LHAMA?

Common products that require TRA:

-Cosmetics (such as skincare products, makeup, shampoo, etc.)

-Toys (bubble water, plasticine, crystal mud, etc.)

-Stationery (such as markers, glue, correction fluid, etc.)

Must comply with LHAMA's products:

Art materials sold to artists/students. Common products include:

-Pigments and Dyes (Oil Painting Pigments, Watercolor, Acrylic Pigments, Chinese Painting Pigments, Ink, etc.)

-Brushes and materials (brushes, canvases, palettes, etc.)

-Modeling and Sculpture Materials (Clay, Gypsum, etc.)

-Adhesive (artistic glue, glue stick, etc.)

-Marking pens (markers, markers, etc.) are typical products under LHAMA's jurisdiction.  

What specific requirements does LHAMA have for product labeling?

Labels that comply with LHAMA must include:

-Declaration of Conformity to ASTM D4236

-If the product has a chronic toxicity risk, it is also necessary to:

1. Warning words

2. Hazard statement

3. Hazardous ingredient names

4. Safety Handling Instructions

5. Allergy ingredient labeling

6. Ways to obtain health information

7. Supplement technical data as necessary

What is the process of conducting TRA/LAMA assessment?

1. Information collection: Enterprises provide complete product information to evaluation agencies, including:

-Complete ingredient list and CAS number, concentration/content of each ingredient.

-Product usage and target user groups (such as children, artists, etc.).

-Normal and reasonably foreseeable usage and exposure routes (such as skin contact, inhalation, ingestion, etc.).

-Existing physical, chemical, or toxicological test data (if available).

2. Toxicological assessment: Toxicologists identify potential hazards (such as sensitization, carcinogenesis, reproductive toxicity, etc.) based on the toxicological data of the ingredients; Based on comprehensive hazard and exposure information, draw a conclusion on whether the product poses an unacceptable risk to consumer health under established usage conditions.

What application materials are required for TRA report and LHAMA compliance?

Materials to be submitted

-Basic product information (name, model, purpose);  

-Target markets (such as the United States, the European Union, etc.);  

-Complete and accurate product ingredient list (including CAS number and percentage content of each ingredient);  

-Product Safety Data Sheet (SDS/MSDS, if applicable);  

-Product process flowchart or brief description;  

-The expected usage and potential exposed population of the product;  

-Existing toxicology data or test reports (if any);  

Does the TRA/LAMA report have an expiration date?

The TRA report itself does not have a fixed 'validity period'. However, updates or reassessments are required in the following situations:

-Changes in product formula (including changes in ingredient types or content).  

-There is a significant change in the purpose or target audience of the product.  

-There are new scientific data or regulatory requirements that may affect the existing risk assessment conclusions.  

-For LHAMA, every time the product formula is changed, it needs to be re audited by a toxicologist to ensure ongoing compliance.