PMPA Regulatory Assurance is how PMPA members gain confidence when dealing with the ever changing and growing area of regulatory compliance.
Here is an example of the kind of sensemaking that PMPA members count on to confidently assure regulatory compliance.
-Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), is a regulation on substances
-Unless exempted from scope or from registration in accordance with Annex IV or V, substances on their own or in preparations are always subject to registration when manufactured in, or imported into, the EU.
-Substances on their own and in preparations in the form of, or contained in, articles produced in or imported into the EU are subject to registration only if they are intended to be released under normal or reasonably foreseeable conditions of use and if this use of the respective substance have not been registered before in the Community.
-In Article 3 (3) of the REACH regulation the definition of an article is given as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
So the question “Do my parts comply with EU REACH Regulations?” boils down to this question: “Do your parts meet the Article Exemption test?”
For an object to be considered an article, the following conditions should be fulfilled:
The shape, surface or design of the object must:
be obtained during production and be special;
be relevant for the function of the object;
- be more important for the function than the chemical composition of the object.
Precision machined products easily meet these conditions:
1. The shape, surface or design of the object must be obtained during production and be special
-The shape and many surfaces of precision machined parts are created by stock removal during production and are regarded as “special”
-Precision machined products are custom produced (special) at the order of the customer.
-They have different dimensions and technical characteristics, as specified by the customer at the time of the order.
-Their surfaces are developed during production to meet the customer’s (special) dimensional and geometric requirements.
2. The shape, surface or design of the object must be relevant for the function of the object
-it is axiomatic that the custom design of the precision machined product is to create the needed form fit and function needed to assure desired performance and function.
3. The shape, surface or design of the object must be more important for the function than the chemical composition of the object
-Precision machined products are machined from a variety of metallic alloys, including steel, stainless steel, aluminum, brass and many others of varied compositions.
-These compositions are varied and determine manufacturability as well as influence mechanical properties, though they are not sole determinants of those properties.
-Without final precision machining to special size, form and geometry, the raw material itself would not provide the needed function demanded by the customer.
Bottom line: Precision machined products are clearly “articles” as defined by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and so exempt from regulation.
Caveat: If during foreseeable conditions of use of the part, it could cause an intentional and forseeable release of a substance that has not been registered before in the Community, you might need to investigate further.
Where do YOU go to get this kind of regulatory assurance?