Regulatory Compliance
Local, State, National, and International
Regulations governing products are a patchwork of initiatives enacted at all levels of government. They impact product design and composition, means of production, marketplace presentation, and even end of life consequences. We all take compliance seriously, but problems arise when either we are not sure how to comply with a rule, or when an applicable regulation goes unnoticed. Such situations are compounded today by global markets that may involve compliance with foreign requirements as well ensuring that imported products, designed and produced under a different regulatory structure, comply with domestic mandate.
Solutions in Science can help you and your legal representatives ensure regulatory compliance on a local, state, national, and international level. Specializing in the chemical and toxicological aspects of product compliance, We can review your product or process in the light of the appropriate regulatory situation and provide technical support through product evaluation, testing, and documentation to fulfill all regulatory mandates. We can also audit your product and process, and from our experience, indicate where potential issues may have gone unnoticed.
US Federal Regulations
Compared to the rest of the world, the US has few laws and regulations governing product safety based on toxicity. There are, however, notable exceptions.
•Pesticides and biocides (EPA FIFRA)
•Children’s products and art supplies (CPSC)
•Claims of safety and toxicity (FTC)
•Novel chemicals (EPA TSCA)
•Hazard communication (OSHA)
•Emissions and discharges (EPA various)
•Waste classification (EPA RCRA)
•Medical devices 510(k) assessments (FDA)
•Food and food packaging (FDA)
•Personal care products (FDA)
•Tableware, silverware, and glasses (FDA)
Solutions in Science can aid companies to comply with these requirements. We provide the guidance technical support, analyses, studies, and documentation necessary to demonstrate compliance.
California's Proposition 65
California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) is a statutory requirement to warn a consumer before exposing them to a chemical; “Known to the State of California of causing cancer or reproductive toxicity.” Proposition 65 relies on citizen prosecutors to bring civil lawsuit to enforce compliance. This has resulted in a cottage industry of special interests whose business model involves finding and litigating products they suspect are out of compliance.
Solutions in Science has a great deal of experience in defending clients from unsubstantiated claims of noncompliance. We use detailed exposure assessments to demonstrate that the allegations are false and that the products are in safe harbor. We also aid consumer product industries in evaluating risks, developing defenses, and improving practices that avoid litigation without impacting sales.
European Union Regulations
Exporting products to the European Union can be challenging. There are many interlinked directives that dictate limitations and requirements that must be met before your product can be permitted into the Common Market. Furthermore, EU rules and regulations are more fluid than we are used to in the US and it can be very time-consuming to keep up with the latest changes.
Solutions in Science works regularly with non-EU clients to identify and comply with EU requirements for import. We specialize in products impacted by REACH, ROHS, WEEE, medical devices (MDR), Food Contact Directives, Product Safety Directive, Toy Safety Directive, and others.
Global Trade and Regulations
Global trade is a two-way street. Whether one is looking to import or export, it is vital to smooth market flow to ensure that one’s products comply with the regulations governing the intended markets. For importers, it is the challenge of ensuring that a product complies with necessary state and federal rules in the US. For exporters, it is aid in working with offshore distributors comply with restrictions and communication standards required in the foreign market.
Solutions in Science can provide our experience by identifying common issues, determining efficient means to address them, and develop the necessary testing and certifications to ensure rapid compliance. Whether for import or export, we can provide support or train your in-house compliance people on the needs to keep products flowing.