Non-food legislation - April 2019

25 April 2019

Medicines and medical devices
A new report (4.96 MB) demonstrates significant resources are required to implement FMD into hospital setting. The report of the European Alliance for Access to Safe Medicines (EAASM) highlights the significant added value that the final patient safety elements of the Falsified Medicines Directive will bring. You can download the full report or read the executive summary.
BMC Health Services Research has published an observational study on errors in packaging surgical instruments based on a surgical instrument tracking system. Wrong instrument specifications were the primary packing error identified in the study. Further effort is needed to standardize the packing procedure for instruments under the same category and more effort is required to reduce the error rate during high risk times, or in the surgery department.

Phthalates review for REACH
12 March 2019 was the deadline for comments for draft recommendation on four phthalates and their endocrine disrupting properties by ECHA (European Chemical Agency). Eurofins says the aim of the recommendation is to update Annex XIV (Authorisation List) to REACH Regulation (EC) No 1907/2006 concerning the following four phthalates to include their endocrine disrupting properties:
Bis (2-ethylhexyl) phthalate (DEHP No. CE204-211-0, CAS No. 117-81-7)
Dibutylphthalate (DBP, EC No. 201-557-4, CAS No. 84-74-2)
Benzylbutylphthalate (BBP, CE No. 201-622-7, CAS No. 85-68-7)
Diisobutylphthalate (DIBP, no. CE201-553-2, CAS84-69-5)

CLP: Twelfth ATP published
Gevaarlijke Lading reports (in Dutch) that the European Commission has published the twelfth Adaptation to Technical and Scientific Progress (ATP) of the CLP Regulation. This implements the changes in the sixth and seventh revised editions of GHS. This is a very long ATP, including new provisions for pyrophoric gases and desensitized explosives. This twelfth ATP will apply from 17 October 2020.

Fake warnings on e-cigarette ads distract kids from truth
Ohio State University published news about how adolescent males respond to fake warnings on e-cigarette ads. The study illustrates the power of tobacco marketing on young people and could serve to inform policy changes governing other products, including combustible cigarettes. The study Adolescent males’ responses to blu’s fake warnings (abstract) was published in Tobacco Control.

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