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Regulatory Consulting Services

Ensure Proper Compliance to Regulatory Guidance

Avomeen is more than a full-service contract laboratory. We also have Ph.D. regulatory experts that can help ensure proper product compliance and registration with FDA, DEA, and EPA regulations.

We can help get your products through its approval stages and onto the shelves.  Our expert analytical scientists have experience with a variety of industries and regulation standards, including:

CODEX Food Laws and Regulations

  • Arsenic
  • Mercury
  • Lead

Chemical Manufacturing Process

  • TSCA (USA)
  • REACh Compliance (Europe)
  • FDA & DEA Compliance (USA)

Product Registration

  • Pesticides
  • Pharmaceuticals
  • Food Packaging

Labeling and Compliance Standards

  • Food Product Testing
  • Shelf-Life Testing
  • Allergen Testing

Avomeen can help you through the entire manufacturing process from product development through product registration. Clients who use Avomeen for their manufacturing quality control processes save time and money by getting all their analytical testing and regulatory consulting services completed at a single company.

Processes like food labeling regulations and EPA testing often require the assistance of an analytical outsourcing laboratory, which for many clients makes the process of getting their products to their customers take longer than necessary. Avomeen can help.

Avomeen’s scientists have experience in Prop 65 testing and CFR validation:
  • Our experts will help with California Prop 65 testing by identifying the specific levels of Prop 65 list components.   With the proper identification and labeling of the ingredients in your product, Avomeen’s environmental testing lab will help earn your company Prop 65 compliance.
  • Avomeen’s Ph.D. chemists are experts in CFR 16 and CFR 21, helping develop comprehensive quality control systems to ensure compliance with the CFR code of federal regulations and providing regulatory consulting services to confirm that all products are properly packaged and labeled for sale.

Avomeen’s scientists can assist in a wide variety of health and safety testing needs. The verification of compliance with all consumer product federal code regulations will keep you and your company safe from the penalties due to violations.

Toxicity Testing & Heavy Metal Analysis

Experts at Avomeen’s Toxicity Testing Laboratory can let you know if your food container, pharmaceutical product, or food product are safe for sale.  Our Ph.D. scientists can perform heavy metal analysis and screens to identify the toxic heavy metals such as lead, arsenic, mercury, and cadmium.

From testing for contaminants, verifying compliance with industry and government regulations, to deformulating a product to analyze all components, our cGMP-Compliant, and FDA-Registered toxicity testing lab can test your products to confirm their safety for public use.

By using extractable and leachable testing, Avomeen can verify that your container or packaging product is not giving off toxic chemicals.  Also by running material identification to breakdown and identify all of the ingredients in a product and cross checking those ingredients with government and industry banned lists, Avomeen can help with your testing and analytical needs.

Avomeen laboratory can perform prop-65 testing services on a variety of items including baby bottles, food containers, and toys.  Our toxicity testing laboratory can make sure that your product is compliant with all consumer regulations.  Our Ph.D. scientists can handle your complex testing and analytical needs.

Phthalate Testing

Due to new regulations, it is now required that manufacturers test for phthalate in a variety of commercial products including those that are used in children toys.

Phthalate testing is often performed on those products composed of polymers, specifically, plastics due to its use as a softener. Recent research indicates its long-term exposure risk can cause damage to endocrine functions and metabolism regulations. The concern over testing for phthalates comes mainly from use in children’s toys, food contact materials, packaging, and other plastic items.  Avomeen’s scientists can perform phthalate trace level detection and testing services.

Not all types of phthalates at this point are banned though, so it is important for manufacturers to keep up with current regulations and ensure that their products are not violating these regulations. Our scientists perform a range of similar testing on chemical detection and identification of chemicals:

  • N-Nitrosamines & N-Nitrosatables
  • Volatile compounds
  • Anti-Oxidants
  • Heavy Metals
  • MBT and 2-Meracaptobenzothiazole
  • DEPH or di(2-ethylhexyl)

Related Testing Services

Bisphenol A / BPA Detection Testing & Analysis

Our Ph.D.-led teams of scientists are experts in chemical migration testing, detection, and analysis services for bisphenol-a commonly referred to as BPA. Many products, especially those used by babies and children should be tested for BPA detection.  This includes products such as children’s toys, feeding bottles, drinking cups, and other polymer products that are used in food and beverage or as children’s products.

Our scientists can perform extractable and leachable testing with instruments like our high performance liquid chromatography otherwise known as an HPLC, and can also perform similar testing for chemical detection on a range of other regulated chemicals:

  • N-Nitrosamines and N-Nitrosatables
  • Phthalates Analysis
  • Volatile compounds
  • Heavy Metals
  • MBT or 2-Meracaptobenzothiazole
  • DEPH

Related Services

Volatile Organic Compounds Testing and Analysis

Avomeen’s VOC testing and analysis laboratory tests for volatile organic compounds testing on aromatic compounds, aromatic hydrocarbons, and emissions in a variety of products. Our chemical analysis experts will test for a large variety of volatile compounds using methods including EPA Method 24. Our chemists can ensure that your product is meeting both government and industry standards, while also helping your company reduce their impact on both humans and the environment.

A VOC analysis can be customized to your individual needs and may include chemical analysiscontent identification, protocol testing, safety analysis, and regulatory consulting services.  Avomeen’s chemists can analyze raw materials, finished products and additives for VOC testing.

Related Services

Toxicity Characteristic Leaching Procedure Testing

Avomeen’s chemists can run TCLP analysis or toxicity characteristic leaching procedure testing for our clients. This analysis determines the leachability, and characterizes hazardous waste. This analysis can determine the mobility of both inorganic and organic analytes. These analytes can be tested for their presence in liquid, solid, and multiphasic wastes.

This type of testing is usually performed at the recommendation of the EPA (Environmental Protection Agency) to determine the safety of these materials and what level of storage or cleanup is required for them. Through a simulation of landfill situations, this type of testing allows one to show potential risks of contaminants or hazardous waste located within a sample that might cause harm to the environment. This type of testing is often down under RCRA (40 CFR Part 261) of D004 through D052 to determine if a waste falls under the definition of EP Toxicity.

What materials are considered hazardous?

  • Toxic “7-11 test”
  • Reactive “Unstable, reacts to water, prone to violent changes”
  • Ignitable “Flashpoint under 140 degrees Fahrenheit”
  • Corrosive “Aqueous levels of pH”
  • Pesticides
  • Those listed in CFR (List of categorized wastes)

Type of tests that are performed (Requirements Vary By State):
TCLP / SPLP – EPA 1311/1312

  • TCLP 10 MDEQ Metals (As, Ba, Cd, Cr, Cu, Pb, Hg, Ag, Se, Zn)
    • SW846 1311/6020/7471A
    • EPA SW846
  • TCLP – VOC’s
    • EPA 8260B
  • TCLP – SVOC’s
    • EPA 8270C
  • Microbiological Parameters
    • Coliform Bacteria – Total/E Coli
      • SM9223B2b P/A (Presence/Absence)
    • Coliform Bacteria – Enumeration
      • SM9223B MPN (Most Profitable Number)
    • Fecal Coliform
      • SM9222D MF (Membrane Filtration)
    • Iron Bacteria
      • BART-IRB

What is Analyzed (Requirements Vary By State):

  • Metal / Semi Volatile Organics
    • Extraction Fee
  • TCLP Metals
    • SW846 7000
  • TCLP Lead Only
    • 7420 FAA
    • 7421 GFAA
  • ZHE / Volatiles
    • 8260B
    • 8021B
    • 8260B
  • Semi– Volatiles
    • 8270C
  • Full TCLP W/O Pest/Herbs
    • 8260B
    • 8270C
    • Organics
  • ZHE / 8010 List Solvents
    • 8260B

Formaldehyde Emissions Laboratory: Laminate and Engineered Hardwood Flooring

Our chemists can verify that your product meets or exceeds formaldehyde emissions standards for composite wood products and that it does not contain or release other toxic chemicals.

Formaldehyde is used in small amounts in a large number of household and personal care products including processed wood products such as furniture, siding, and flooring.  But in high concentrations, it can be a dangerous health hazard.  Verify that your products are free from unsafe levels of formaldehyde off-gassing in order to protect the indoor air quality of your products consumers and your brand’s public image. Our laboratory can analyze subfloors, adhesives, ceramic tiles, laminates, hardwoods, bamboo flooring and more for:

  • Lead Content
  • Formaldehyde (NAF)
  • Urea Formaldehyde (NAUF)
  • Ultra Low-Emitting Formaldehyde (ULEF)
  • Volatile Organic Compounds (VOC)
  • Other Toxic Chemicals

Let’s work together to achieve your vision

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