The EU Biocides Product Directive (BPD) (98/8/EC) seeks
to remove barriers to trade by harmonising controls for
marketing across Europe. The BPD also seeks to ensure
a high level of health and environmental protection. The
onus is therefore on industry to conduct hazard and risk
assessments on their products and seek approval from the
relevant regulatory authorities.
Acta EU focuses on biocides
and biocidal products regulation and support services
to assist industry in tackling the intimidating landscape
of increasing chemical regulation.
Acta EU’s experience
in the biocide, industrial chemical, agrochemical, biotechnology,
and nanotechnology sector allows it to offer a complete
package of consultancy services for the European Union’s
(EU) regulatory framework.
Acta EU professionals, working
closely with their U.S. affiliates, The Acta Group, L.L.C.
and Bergeson & Campbell, P.C., offer a full range of biocides
and biocidal products regulatory services.
General Chemical Hazard
Identification and
Risk Assessment Services
Assess the need for registration under
BPD, including the identification of the
need for Annex 1 listing or the
possibility of application by “Letters of Access”
Identify
data gaps
Prepare summaries, partial or full dossiers,
and International Uniform Chemical Information Database
(IUCLID) files and management for both active substances
and biocidal products
Submit dossiers to relevant Member
States for Application for Annex 1 listing of an active
and/or biocidal product authorisation
Identify companies
with structurally similar products or products of a similar
nature to create and manage a consortia for testing and
data submission
Provide hazard data appraisal and literature
reviews (toxicology, environmental, physical/chemical)
Prepare
risk assessments and appraisals for all exposure groups
via all routes of exposure
Offer study design and
management (human health and environmental)
Prepare safety data sheets, product labels, chemical
safety assessments, and reports
Provide product support
from concept to approval
Prepare risk management proposals
Design,
implement, and complete a cost-effective testing program
Discuss
specific needs and issues with appropriate legislators
and regulators
Act as the “Only Representative” for
companies that are not legal entities in the EU
Offer
post-regulatory product support
Other EU Chemical Directives/Programmes Served
Registration, Evaluation, and
Authorisation of Chemicals (REACH)
Engineered Nanoscale Materials and Nanotechnology
AgroChemicals
91/414/EC
EU Classification 67/548/EEC & Labelling
1999/45/EEC
