European Economic and Social
Public Hearing on proposed
Regulation COM(2013) 619
Dr Des Corrigan
Trinity College Dublin
EU Commission Assessment of the functioning
of CD 2005/387/JHA (COM (2011)430
∗ Unable to tackle groups of similar substances- Not
adequately addressed by COM(2013)619
∗ Reactive- Still not Proactive
∗ Lengthy process – Welcome Article 9
∗ Lacks options for regulatory & control measures- Better
alignment of laws in the field of drug control, product &
food safety, medicines & consumer protection.
Groups of Similar Substances
∗ Article 6.2(b) refers to “other NPS with a similar
chemical structure that have emerged.”
∗ Should read “ that have emerged or
which might reasonably be expected to
emerge, based on scientific assessment
∗ Art. 11 in conjunction with Art. 3 implies legal
availability & free movement of certain NPS within
the EU. This is based on an assessment process which
is not adequately aligned with the public health
protection standards applied to all other consumer
Article 11 (contd)
∗ No requirement for any manufacturer etc of a NPS to have
a legal presence in EU.
∗ No requirement to adhere to any Code of Manufacturing
∗ No onus to report adverse events to a Competent
∗ No restriction on sale to under-18s or on advertising.
∗ Onus on EMCDDA & COM to show evidence of low risk
∗ Onus SHOULD be on promoters to prove safety.
CD 92/414/EEC concerning the placing
0f plant protection products on the
∗ Dossier to be supplied by applicant must include inter
∗ Oral cumulative toxicity involving one rodent & one nonrodent species- usually 90 day study
∗ Mutagenicity- gene mutations, chromosomal aberrations &
∗ Reproductive Toxicity – Teratogenicity studies in rabbit &
one rodent species; multigenerational studies in mammals
( at least two generations).
∗ Neurotoxicity studies including delayed neurotoxicity tests
∗ NOAEL, NOEL & ADI
∗ NPS which cannot be shown , by those profiting from their
sale, to be safe for human use, using standard toxicity
tests including Carcinogenicity, Mutagenicity &
Reproductive Toxicity as well as Neurotoxicity, should NOT
BE PERMITTED on the market.
∗ This applies whether the NPS is consumed on its own or in
combination with other NPS , controlled drugs, medicines,
caffeine, alcohol or tobacco.
∗ Articles 10-13 should be redrafted to reflect this approach.