8 replies to this topic

[oleg.spiess]

Hello everyone,

 

We are a manufacturer of plastic packaging for various markets. Our site in Brazil is planning to manufacture and distribute primary packaging for the food industry.

 

We are currently preparing a test plan for material analysis (migration tests). We have obtained confirmation of the food conformity (DoC) of these raw materials from the raw material suppliers and would like to test the finished products on a random basis to be on the safe side. 

 

I am not familiar with Brazilian food legislation.

Which analysis and with which simulants would be suitable for this?

I mean, if the suppliers confirm the suitability, we don't have to do the global migration test again, do we?

Would a 10 ppb Screeneng (NIAS screening) be sufficient in this case?

 

How do you do this in your companies? 

 

I would be grateful for any answers

[SQFconsultant]

In the eyes of a customer it is hard to justify doing the minimal because the customer is told that the supplier has done the testing already - in general, I have minimal trust for a supplier telling me (and even showing me documentation) this - thus we do everything up front, even if done already by the supplier and then randomly after we have a established a supply relationship.

[oleg.spiess]

In the eyes of a customer it is hard to justify doing the minimal because the customer is told that the supplier has done the testing already - in general, I have minimal trust for a supplier telling me (and even showing me documentation) this - thus we do everything up front, even if done already by the supplier and then randomly after we have a established a supply relationship.

 

Hello and thank you for your answer.

 

The supplier relationship has already been established, some of them are long-standing suppliers.

These are mainly large, well-known suppliers who operate internationally.   We have over ten material types.

Doing a complete migration analysis for each type of material seems a bit expensive to me. 

 

Is it permissible to issue the declaration of conformity on the basis of the supplier confirmations?

 

Thank you

[Sarahi Vazquez Romero]

Hello, I am in Mexico and I request that my suppliers comply with European and American regulations such as: • General migration (Commission Regulation (EU) No. 10/2011 plastic materials and articles intended to come into contact with food)
• Heavy metals (Commission Regulation (EU) 2016/14/16 amendments - specific migration of heavy metals)
• FDA 21 CFR 177.1520
 (d)(3)(ii) Extractable fraction
 (d)(4)(ii) Soluble fraction
 (d)(1) Density (23°C),

PFAS and Bisphenol-A (BPA) are also important as well as microbiological indicators

 Aerobic mesophiles
 Total coliforms
 Fungi and yeasts

[oleg.spiess]

Hello, I am in Mexico and I request that my suppliers comply with European and American regulations such as: • General migration (Commission Regulation (EU) No. 10/2011 plastic materials and articles intended to come into contact with food)
• Heavy metals (Commission Regulation (EU) 2016/14/16 amendments - specific migration of heavy metals)
• FDA 21 CFR 177.1520
 (d)(3)(ii) Extractable fraction
 (d)(4)(ii) Soluble fraction
 (d)(1) Density (23°C),

PFAS and Bisphenol-A (BPA) are also important as well as microbiological indicators

 Aerobic mesophiles
 Total coliforms
 Fungi and yeasts

 

Hello and thank you for your reply. I am familiar with European food law. I am familiar with almost all of the regulations you have listed. EU Regulation No. 10/2011 is not directly recognized in Brazil. Brazil has its own specific regulations and requirements, which are set by ANVISA. And that is my current problem. 

[Sarahi Vazquez Romero]

Hello and thank you for your reply. I am familiar with European food law. I am familiar with almost all of the regulations you have listed. EU Regulation No. 10/2011 is not directly recognized Resolution 105/99 and Collegiate Council Resolutions 88/2016 and 56/2012, which have been updated to internalize the new Mercosur regulations, in line with European regulations. The first, Resolution 105/99, deals with general provisions for plastic containers and equipment in contact with food. The update consisted of modifying the limits and restrictions of the total migration of dyes, with the purpose of adapting them to Mercosur GMC Resolution 56/1992. The second, RDC 56/12, presents a positive list of monomers, other initiating substances and polymers authorized in plastic containers, and its change consists of (i) reduction of the authorized specific migration limits of the substance Bisphenol A and (ii) ) incorporation of new substances approved by ANVISA in line with European regulations and Mercosur (GMC Resolution 02/2012) (Source).

[Tflex]

What exactly is your manufacturing process?

[oleg.spiess]

Hello,

 

We produce by means of injection molding and blow molding.  This means that we add other materials (masterbatches) to the base material (PP or PE) in small percentages. 

 

However, there are also products that are manufactured using only the base material, without the use of additives. Theoretically, I could take the SML from the supplier document, as we don't add anything else apart from heat. 

 

It is much more difficult with the mixed materials. Do we really have to subject all mix variants to a migration test? There are a lot of them. When I consider that a migration test costs around 1500 EUR, it adds up to a large sum. 

 

How do you deal with this in your company?

 

Thanks

[beautiophile]

 

However, there are also products that are manufactured using only the base material, without the use of additives. Theoretically, I could take the SML from the supplier document, as we don't add anything else apart from heat. 

 

I don't think you should exclude these products. Thermal degradation & exposure during processing may increase or produce certain chemicals related to SMLs.

 

 

It is much more difficult with the mixed materials. Do we really have to subject all mix variants to a migration test? There are a lot of them. When I consider that a migration test costs around 1500 EUR, it adds up to a large sum. 

AFAIK, auditors accept that one test represents a product/variant group as long as the grouping is reasonable.