Do Regulatory Documents Have a Freshness Date?

March 29, 2016 • Posted in Technical

One of the most common questions I hear regarding regulatory documents is, “Don’t you have anything more recent?”

Some people believe if a document is over a year old, it’s no longer valid. However, unlike bell-bottom pants and mood rings, regulatory documents can stay fresh, despite their age… though there are exceptions to this.

Take, for example, a letter stating FDA-compliance. Often, a resin manufacturer does not have their material tested annually for compliance – simply because the legislation has not changed in a long time, and more than likely the formulation of the resin has not changed. If there’s been no change to the “recipe” of the plastic resin and it passed once, it is going to pass again and again. If a manufacturer issues a letter in 2010 stating their material is compliant – and there have been no changes – it will still be compliant in 2016.

Our general rule of thumb is this: A regulatory document remains valid indefinitely unless one of four things occurs.

First, the plastic resin manufacturer changes the formulation of a product so that its regulatory status could potentially change (example: they replace an animal-derived additive with one that is chemical-based, or they change a catalyst). Often, such additive changes lead to the grade name changing – meaning all-new documentation is needed.

Second, the legislation changes, requiring an updated statement – even if it is still in compliance (example: the bi-annual updates to Substances of Very High Concern).

Third, the manufacturer decides, for reasons unknown to us, to withdraw their statement of compliance. (This is rare, but it does happen.) When this happens, if we are informed of the change, we will inform our customers who purchase this material that such a change has occurred.

Finally, the manufacturer may specify an expiration date on their letter – in which case, we’ll work with the manufacturer to obtain a more current letter for you. These are especially common on all-inclusive regulatory statements, where many of the items they cover are regularly updated, or the manufacturer decides to include more information as demand for it rises.

Safety Data Sheets (SDS) are currently handled a little differently. In the United States, as long as the SDS is compliant with the Global Harmonized System (GHS), and as long as the information in the document remains accurate, a resin manufacturer does not have to issue regular updates to it. However, in Canada, it is currently the law that SDS must be updated every three years; it remains to be seen whether their adaptation of GHS will continue this practice.

Does this mean you can’t ask us if a document is still valid? Naturally, we’ll be glad to address your questions on materials you are currently purchasing from M. Holland (or that your Account Manager is actively quoting you). If you have an FDA-compliance statement that’s a few years old, you’re most likely fine with the documentation you have on hand. But, chances are, if you’re holding onto a Proposition 65 statement from 2008, you will need an updated declaration… and we can help you with that.

Do you need any such documents? Or do you have any regulatory questions? Feel free to e-mail me Chris Thelen.

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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