April 13, 2016 • Posted in Technical

Common Regulatory Questions You Should Ask

It is nearly impossible to be completely prepared for one’s regulatory needs, simply because the field changes on a constant basis. One day, you think you’ve got everything you need; the next day, your customers are clamoring for a statement on “Chemical X” because some report on a website claimed exposure causes a wide variety of maladies. (Remember the melamine panic a few years ago following the cases of tainted dog food in the US and milk powder in China? We still get inquiries about its possible presence.)

However, when you are selecting a branded prime plastic resin for your specific application, there are a few tried and true questions that you should be asking the people using the parts you make prior to purchasing the resin.

  1. Is the end product going to be in contact with any foods or liquids? If so, you need to make sure the resin you are selecting is Food and Drug Administration (FDA) compliant. (There is no such thing as an “FDA cert”; the FDA simply issues guidelines a resin must meet in order to be used in food contact applications.)Similarly related, is the end product going to be sold in Canada? You can find out if the resin has received a “letter of no objection” from Health Canada (their version of the FDA – the main difference being that Health Canada does authorize each resin). However, if your customer needs approval from the Canadian Food Inspection Agency (CFIA), this is issued on the finished good, not individual ingredients such as resin. Obtaining the Letter of No Objection is a major first step towards CFIA approval.
  2. Is the end product going to be sold in any state that has “right to know” laws? Most of these are simply covered by the Safety Data Sheet (SDS), but if the product is to be sold in California, you will need a statement regarding California Proposition 65 – that is, any substances present known to the state of California to cause cancer.A quick note about Proposition 65: Just because a listed chemical may be present in the resin, that does not mean either that the resin is dangerous or that it’s not appropriate for the finished good. The answer to this question lies in the finished good, and whether the total concentration of such chemicals is higher than the “No Significant Risk Level”. The final responsibility regarding a product’s status under Proposition 65 lies with the individual doing business in California.
  3. Is the end product going to be sold in the European Union? If so, you will want to make sure that the resin manufacturer has registered the components of the resin with REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), which is essentially the European chemical database. To that end, you’ll need a statement regarding Substances of Very High Concern (SVHC) – the portion of REACH legislation that affects thermoplastic resin. (Speaking of the field constantly changing – SVHC is updated at least twice every year, so you will need to get updated statements from M. Holland.)
  4. Recently, we started listing basic regulatory questions that you should be asking your end-user prior to selecting a resin for applications. Here’s the second half of that list (which is, by no means complete):
    Is the end product a children’s toy or good, or a child care product? The Consumer Product Safety Improvement Act (CPSIA) looks for the use of lead, cadmium and phthalates in the components To comply, you will need, at the very least, a statement on phthalates and a CONEG (Coalition of Northeastern Governors) or RoHS (Restriction of Hazardous Substances – Europe’s version of CONEG, albeit expanded) statement. (Both CONEG and RoHS cover, among other substances, lead and cadmium.)
  5. Is the end product for use in the automotive industry? Check with your M. Holland account manager to make sure that the resin meets required auto specifications, and if you are a member of IMDS (International Material Database System), that the resin producer participates. (Not every resin producer chooses to participate in IMDS; this is a voluntary system.)Similarly, does the end-user need a declaration regarding the Global Automotive Declarable Substance List (GADSL)? Quite possibly, this will suffice when sourcing in a resin from a manufacturer who does not participate in IMDS.
  6. Is the end product for use in the medical field? If the answer is “yes” – especially if the finished good makes any kind of contact with bodily fluids or tissues – you will want to work closely with your account manager. Many resin manufacturers forbid the use of their resins in medical applications. Often, when we have a resin which will fit the application and use, we still need to get the resin manufacturer involved, as some want to know the applications, and can grant approvals for such uses. Often, we may need you to complete a medical use form; once we receive the completed form, we immediately send it to the resin manufacturer.However, when we have to make such a submission, the answers might not arrive quickly – so you need to allow a minimum of ten business days for the resin manufacturer to respond to the query. (It sometimes can take even longer, especially if the request has to be researched and vetted.)

If you meet any resistance from your customer when asking these questions (e.g., they say the end product is a “trade secret,” all you need are simple yes or no answers to many of these questions. However, some resin manufacturers will want to know the application the resin is being used for, especially in the case of IMDS – in which case, a very generic answer is all that needs to be provided.

Finally, if you do need to request any regulatory documents from M. Holland, please don’t simply ask for the “regulatory statement”. This is because not every resin manufacturer has an all-inclusive document which addresses many of the common questions which may arise. The more detailed your request is, the better we can address your concerns and get documentation out to you in a timely manner.

Once you know the answers to these basic regulatory issues, you can work with your account manager to get the necessary documents. However, just like you cannot anticipate every regulatory need your own customer has, there’s no way to adequately address every single possible regulatory hurdle you may have to clear in a simple blog post (or two… or twelve). If you have any questions of a regulatory nature please feel free to contact me at: cthelen@mholland.com.

If you would like to learn more about M. Holland and the plastic resin solutions we provide, submit a form and an M. Holland representative will follow-up with you.

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