Regulatory Services

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Chemical compliance can be very complex and require a level of regulatory and document management expertise that many organizations can no longer afford to support. The landscape within regulatory bodies worldwide is continuously changing. Maintaining the highest level of compliance requires:  Sophisticated software, global databases of regulations and an EH&S team to understand the nuances of regulations, as country policies are becoming more stringent at the borders. Today, the documents you rely on to get your products from point “A” to point “B” are becoming more complex. Fines for non-compliance and shipment delays are more common than ever before.

  • Drawing upon our deep understanding of the chemical industry, we offer a variety of regulatory services to ensure that your safety data sheets and labels comply with the local, regional, and global chemical regulations such as GHS, CLP and REACH, to name only a few.

We bring you access to our worldwide network of experts and professionals with knowledge of:

  • Compliance issues pertaining to the latest local and global chemical legislations and regulations
  • Related information such as Chemistry, Industrial Hygiene and Toxicology
  • Logistics information related to the transport of chemical products by road, air or sea
  • Translation of chemical-related documents in country-specific languages

We can assist with:

  • Regulatory compliance strategies for your company
  • Development of product-related processes in compliance with local, Federal and International regulations
  • Regulatory research consulting services
  • Risk assessment and regulatory gap analysis (GHSMart©)
  • Compliance guidance reports for new product development initiatives (GHSMart©)
  • Hazardous assessments by substance and country during your product reformulations (GHSMart©)

Hazard Assessments

Where does your company stand with respect to chemical regulations and directives?

Chemical Manufacturers, and even Distributors must be well informed on which countries are adopting restrictive laws on substances.

High Production Volume (HPV) chemicals are being screened by the OECD and Substances of Very High Concern (SVHCs) are tightly regulated by REACH in 27 EU countries. The European Chemicals Agency (ECHA) regularly publish a list of SVHCs for authorization and many substances that have been on the EU market for decades will eventually be banned and replaced by less hazardous substances. These lists are CHANGING FROM YEAR TO YEAR!

Would you, and your R&D team like to benefit from real-time knowledge about how the changes in chemical regulations affect your products classifications?

Some commonly asked questions we hear regarding changing chemical regulations include:

  • What will my products classifications be in a new market or country?
  • Are any of my substances on a “list of lists” (regulated or banned substances)?
  • Have any of the substances in my finished products gone over "concentration thresholds” to require notification?

KMK Regulatory Services can work with your company to identify the potential risks and issues of non-compliance. We can provide a clear window into the coming regulatory landscape, as if you had a “crystal ball view”. Our network of experts provide consulting services on chemical regulations and directives including REACH, the GHS, the HPV program, and more. Your partnership with KMK will help your company avoid risks of non-compliance.

We can assess your products and their level of hazard against current regulations by:

  • Analyzing your products given the composition of the mixture and ingredients responsible for the hazard (GHSmart©)
  • Offering country and classification-specific information for ALL COUNTRIES worldwide.

Yearly Maintenance Program

KMK is your partner in ensuring your ongoing compliance

KMK’s yearly compliance program provides customers a cost-effective way to ensure that the documents we’ve authored for them are always updated and remain in compliance over time despite changes in data and regulations. Our service is comprehensive.  We continuously monitor each substance in your finished products to ensure that your documents are changed in time, to remain in compliance with the various laws and regulations.

We offer:

  • Continuous regulatory monitoring for amendments in chemical classifications and global regulations
  • Real-time SDS, label revision, validation and updates to keep up with modifications, when requested by local regulations
  • Minor modifications such as; concentration ranges (if this does not force a classification change), address changes, brand name, product use and corporate information changes will be made at the time of the maintenance of your documents

Your documents must be updated on a yearly basis (Our databases are updated each quarter).

We receive new and updated scientific and regulatory data every quarter, and we will update your SDSs and labels accordingly once a year. Here are some examples of data that comes out on a quarterly basis:
  • Changes in classification of substances in Europe
  • Changes in Occupational Exposure Limits in various countries
  • Listed substances in various Regulatory Lists including the California Prop 65 in the United States
  • Toxicity, and eco-toxicity data