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Acceptance Criteria EU?
I’m afraid you’ll have to bear with me on this one.
Looking at producing an oil-wax based, pigmented mixture in a reasonably archaic facility. It’s spreadable and with some emulsifiers for wash-off but ultimately should remain on skin for long periods in sweaty/wet conditions, but doesn’t feature water in its ingredients. The shades this product can be produced in are reasonably specific.
All else aside, what sort of acceptance criteria would you suggest for the above product? The EU guidance stipulates that acceptance criteria must be tested in a laboratory, but doesn’t stipulate what acceptance criteria should (or typically does) cover. Thanks in advance.
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4 Replies
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Accepotance criteria in what context? Might consider ISO 29621 for micro risk. https://www.iso.org/obp/ui/#iso:std:iso:29621:ed-2:v1:en
“Reasonably archaic”. Please don’t be casual re. GMP’s. Per the Drective:
To ensure their safety, cosmetic products placed on the
market should be produced according to good manufacturing practice. -
PhilGeis said:1. Accepotance criteria in what context? Might consider ISO 29621 for micro risk. https://www.iso.org/obp/ui/#iso:std:iso:29621:ed-2:v1:en
2. “Reasonably archaic”. Please don’t be casual re. GMP’s. Per the Drective:
To ensure their safety, cosmetic products placed on the
market should be produced according to good manufacturing practice.1. Exactly. I’ll have a look into the standard but neither the EC No. 1223/2009 or ISO 22716:2007 are particularly explicit on examples of acceptance criteria, nor tests specific to acceptance criteria.
2. Yes, of course. I’ve probably painted it in a poorer light than it deserves, truthfully. The only aspect that is truly ‘missing’ right now is the tests for acceptance criteria.
Would colourimetry suffice in the case of certain shades/colours of product? Or specular gloss tests if it was matte (or glossy)? What about spreadability? -
Benz3ne said:PhilGeis said:1. Accepotance criteria in what context? Might consider ISO 29621 for micro risk. https://www.iso.org/obp/ui/#iso:std:iso:29621:ed-2:v1:en
2. “Reasonably archaic”. Please don’t be casual re. GMP’s. Per the Drective:
To ensure their safety, cosmetic products placed on the
market should be produced according to good manufacturing practice.1. Exactly. I’ll have a look into the standard but neither the EC No. 1223/2009 or ISO 22716:2007 are particularly explicit on examples of acceptance criteria, nor tests specific to acceptance criteria.
2. Yes, of course. I’ve probably painted it in a poorer light than it deserves, truthfully. The only aspect that is truly ‘missing’ right now is the tests for acceptance criteria.
Would colourimetry suffice in the case of certain shades/colours of product? Or specular gloss tests if it was matte (or glossy)? What about spreadability?Furthering your point 1. Acceptance criteria in terms of finished product. We’ve relied on supplier CoA given our quality standard stipulates supplier audit etc. as outlined in 22716:2007.
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Think you can develop your own technical defense re. principles established in 22716. Avoid PET defining your risk - if you must generate data - try some in-use testing..
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