Comparison between 10/2011/EU and 21CFR175 300
I was wondering if anyone can assist me please?
We are looking at a new source of aprons and armbands from an American supplier, however the products have not been tested in line with the requirements of EU legislation, namely 1935-2004,10-2011 or 202-2014 but do comply with 21CFR175 300.
Will a product which complies with 21CFR175 300 in principle also be compliant with the EU legislation in regards to "in contact with food"? If it does, will this be sufficient evidence for auditors and retailers within the EU and especially UK and Ireland, that the items meet all requirements in regard to in contact with food?
I was wondering if anyone can assist me please?
We are looking at a new source of aprons and armbands from an American supplier, however the products have not been tested in line with the requirements of EU legislation, namely 1935-2004,10-2011 or 202-2014 but do comply with 21CFR175 300.
Will a product which complies with 21CFR175 300 in principle also be compliant with the EU legislation in regards to "in contact with food"? If it does, will this be sufficient evidence for auditors and retailers within the EU and especially UK and Ireland, that the items meet all requirements in regard to in contact with food?
Hi Sheena,
I fear most people here will have zero idea as to what yr refs are, any chance of posting them or linking them ?
I thought armbands were only used on a football field.
I think from EC 10/2011 may help you
Plastic multi-layer materials and articles
1. In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.
2. By derogation from paragraph 1, a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may:
(a)
not comply with the restrictions and specifications set out in this Regulation except for vinyl chloride monomer as provided in Annex I; and/or
(b)
be manufactured with substances not listed in the Union list or in the provisional list.
Also, by chance, what is the type of resins used in these aprons and armbands (chemical composition).
Aprons and arm bands (do you mean disposable sleeve covers?) should only come into contact with food on an accidental/occasional basis. For this reason, one might argue that EC 1935/2004 and 10/2011 might not be so much a legal requirement for your European customers but a rather a means for them to show they are covering off potential food safety risks from chemical migration into food from the aprons.
Compliance to US FDA CFR21 175.300 is often used in countries outside of the USA to show that the plastic used to make items like aprons is 'food-safe' but it is NOT the same as EC 1935/2004. On the issue of chemical migration from plastics into food US FDA 175 - 178 and EC 10/2011 are often considered to be equally acceptable as a means to show a plastic item is 'food-safe'. But the EC rules are different and they also address other issues in addition to chemical migration, such as traceability and hygienic manufacturing practices. FDA 175.300 does not.
So perhaps it would be best to ask your customers if they would accept compliance with FDA 175.300 from a risk-management perspective or do they want legal compliance to EC 1935/2004 and EC 10/2011?