New version of the POP Regulation published

Persistent organic pollutants (POP) refer to chemical compounds whose breakdown or conversion in the environment only occurs at a very slow rate. In 2004, the Regulation (EC) No. 850/2004 on persistent organic pollutants – short form: POP Regulation – was published with the goal of improving the protection of the environment and human health. Since then, the regulation has been revised multiple times. As changes are once again pending, the EU has decided to completely revise the regulation.

The new version was released on June 25, 2019 in the official gazette of the EU: Regulation (EU) no. 2019/1021. There were also changes, among other things, to Annex I, which concerns substances banned in materials, mixtures and articles. For example, the limit for the flame retardants tetra, penta, hexa and heptabromodiphenyl ether in materials, mixtures and articles amounted to 10 mg/kg to date. The limit will only apply to materials in the new version. Decabromdiphenyl ether has also been included. A total limit of 500 mg/kg for all polybrominated diphenyl ethers listed in Annex I now applies for mixtures and articles.

Pentachlorphenol as well as its salts and esters have also been adopted in Annex I. Unfortunately, a limit has not been defined. Unintended trace contamination is, however, still permitted.

The new version of the regulation took effect on July 15, 2019.

REGULATORY UPDATES:

Harmonization of the chemicals ordinance with EU requirements for Switzerland

The Swiss confederation is now taking a further step towards harmonization.  The European chemicals regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals – abbreviated with REACh – has been in force since 2007. It serves to provide a high level of protection for human health and the environment while also enabling the free distribution of chemicals within the EU.   Switzerland is not a member of the EU. However, part of the chemicals ordinance has already been adapted to EU requirements in recent years. 
As a result, the Swiss Federal Council published an amendment to the Ordinance on Chemical Risk Reduction [ChemRRV] on April 17th, 2019.  A number of sections aligned with the recently adopted rules of the REACh regulation will be revised or added. The following restrictions, among others, will be introduced:
 

• Phthalates BBP, DBP, DEHP and DIBP in consumer products. Limit <0.1 % (sum)

• PFOA perfluorooctanoic acid and its precursors. The limit 25 ppb for PFOA and its salts, 1000 ppb for PFOA precursors

• Decabromdiphenyl ether DecaBDE. Only contaminants that cannot be avoided are permitted.

• Nonylphenol ethoxylate NPEO. Limit of 0.01 % in washable textile fibers as well as textile products.

• Methanol. Limit of 0.6 % in windshield washer fluids and windshield antifreeze agents

• Octa and decamethylcyclotetrasiloxane. Limit of 0.1 % in washable cosmetic agents

The complete text with all changes and details can be viewed on the web pages of the Swiss government.  The amending regulation took effect on June 1, 2019.  However, a number of the restrictions will first take effect later on between December 1st, 2019 and June 1st, 2024.

What is the definition of Quality Assurance (QA)?

The maintenance of a desired level of quality in a product, especially by means of attention to every stage of the process.  A procedure or set of procedures intended to ensure that a product (before work is complete, as opposed to afterwards) meets specified requirements.

QA is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers. QA is applied to physical products in pre-production to verify what will be made meets specifications and requirements, and during manufacturing production runs by validating lot samples meet specified quality controls.

Quality Assurance refers to administrative and procedural activities implemented in a quality system so that requirements and goals for a product or activity will be fulfilled.   It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention. 

Two principles included in Quality Assurance are: “Fit for purpose", the product should be suitable for the intended purpose; and "Right first time", mistakes should be eliminated. QA includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes.

CPTS