I'm in realy need to know if lot number must appear in a declaration of conformity. So I thought this will be a good place to ask.
Does anybody know a european or italian law that explicitely requiers lot number to appear on a declaration of conformity for materials in contact with food? I've not found such an explicit requierment in 1935/2004/ce, yet my clients keep pressing me to write lot numbers in the Declaration of Conformity requiered by 1935/2004/ce. I have a traceability system in place, but each delivery consists of dozens of lots, so it will be difficult to me to mention all of them in the DC. And I would rather not.

In Regulation (EC) No. 1935/2004, Article 2a), it states: ‘traceability’: the ability to trace and follow a material or article through all stages of manufacture, processing and distribution.

Traceability is further explained in Article 17 were it states, "...shall be identifiable by an appropriate system which allows their traceability by means of labelling or relevant
documentation or information".

I will venture to say this is the reason behind your "clients" asking for lot numbers to be on the Declaration of Conformity.

In case anyone is interested in Regulation (EC) No. 1935/2004 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:338:0004:0017:EN:PDF).

Hope this is of some help.

Yep, it says so.
Each batch is labeled with a unique number. And I can trace it back to raw material. But I'm asked to write these numbers in the Declaration of Conformity. I need to know if I'm really need to.

What value is a declaration of conformity without reference to what product it's about? :confused:

I have to agree with howste, what value does a declaration have without reference to what product it's about.

IMHO, Even though the regulation does not specifically say "lot numbers" must appear on the Declaration of Conformity. I personally interprete it has being implied.

No, none of the CE marking directives requires to include a lot number in the Declaration of Conformity. The reason is that the CE marking relates to a type approval, not a batch or lot approval. So you have to indicate the product and model(s) for which you declare conformity.

Han

Hi,

Could there be a confusion between "Declaration of Conformity" and "Declaration/Certificate of Conformance" ?

See this thread. (http://elsmar.com/Forums/showthread.php?t=25308&highlight=declaration+conformance)


regards
t.

No. I konw the differnces between the "Declaration of Conformity" and "Declaration/Certificate of Conformance".
I see that the the common perception is that lot number should be included in DC. So I'll find a way to do it.
Thanx everyone.

Hi

If you are refering to the Declaration of Conformity for CE Marking purposes, Lot Numbers are not required. See Meddev S/01/99 for the required contents. Also have a look at page 15 of Meddev NB-Med 2.5.1. (http://www.meddev.info/)

Chris

If you are refering to the Declaration of Conformity for CE Marking purposes, Lot Numbers are not required. See Meddev S/01/99 for the required contents.

Chris,

We are referring to a Declaration of Conformity pertaining to product that comes into contact with food.