1946, Toxic Substance Control Act (TSCA), the National Premier Chemical Management Law of The Unites States of America has been amended and will be replaced by FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT (LCSA). This new law which was enacted on 22nd June 2016 by President Obama with the support from both the U.S. House of Representatives and the Senate, includes much-needed improvements such as:
- Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines;
- New risk-based safety standard;
- Increased public transparency for chemical information; and
- A Consistent source of funding for EPA to carry out the responsibilities under the new law.
- All chemicals will undergo a risk-based safety review for the first time.
- EPA will identify the highest priority chemicals using transparent criteria and processes and then subject all high priority chemicals to thorough risk evaluations.
- EPA’s risk evaluations will be based solely on considerations of human health and the environment using the most credible science and will no longer consider costs when determining a chemical’s safety.
- EPA must consider risks to vulnerable groups like infants, pregnant women, children, and the elderly.
- EPA will have a clearer legal authority to request that manufacturers conduct more health and safety tests on chemicals and to apply restrictions on chemicals when warranted.
- The public will have greater access to information about chemicals, including health and safety data.
LCSA makes changes that will create a stronger federal chemical regulatory system wherein:
The US FDA has more standards and guidelines towards promoting and protecting the health aspect that is covered in the details on their official website. The majority of the substances manufactured find their path one way or the other into food and drug either directly, indirectly or through their packaging materials as is advised by 21 CFR.
Trust House Solutions can help you submit for a Food Contact Notification and obtain an FCN number as well, for your chemical substance having an end use as an indirect food contact.
Again, there is a CDR and this is to be done through CDX and the window for the same opens once every four years.
We can be your one-stop solution for all regulatory compliance in the US for the following regulations and also support with FCSA related requirements as well.
- Food Contact Substance Notification (FCN)
- TSCA and it reform FCSA (EAN #)
- PMN (Product Manufacturing Notification)
- California Proposition 65
- HCS (GHS/SDS)
We always say
“To be compliant to a regulatory requirement in time in real sense can’t be called ‘in time’ for you need to be ready before the time”.