1. Chemical Regulatory “hurdles-marathon”
Jan Holomek, ReachSpektrum
Chemicals Management Forum 2018
Belgrade, Serbia

2. Without chemicals, it is impossible to secure basic needs of our culture
The most important external part of (human) life
The strictest regulations in the World
Protection of human health/Environment
Water and pollution by chemicals and influence of chemical on human health and environment are the mots discussed topics
EU goals
Secure the (drinking) water quality
Better air quality, lower the noise
Reduce or eliminate negative effects of chemicals
Protection of shared sources: water, air, natural areas, plants/animals
Sharing of law and regulations protecting them.

3. Chemicals regulation in EU
Chemicals in general
REACH
CLP
Specific groups
By use - Biocides, Pesticides, Cosmetics, Pharmaceuticals…
By properties – Endocrine disruptors, Nanomaterials…
Transport
ADR/ADN/RID/IATA
External
Waste
Air pollution, Emission Trading System
Water protection regulation
Energy efficiency

4. REACH Regulation EC 1907/2006 Goal Why? Better human health protection
Raised environmental protection
Support sustainable innovation and competitiveness.
Why?
Missing information on chemicals, as testing was started in 1981 as mandatory
Risk assessment is responsibility of industry
Replacement of the most dangerous substances by safer alternatives

5. The REACH effect

6. CLP Regulation 1272/2008 CLP – classification, labelling and packaging
”Visual” interpretation of REACH findings
Same criteria for CSA
Raising level of protection of human health and environment
Agreement on how to communicate risks in the EU
Goal
Become harmonised with the UN system (GHS)

7. Export and import Regulation EC N. 649/2012
Export and import o dangerous chemicals
Annex I
industrial chemicals, pesticides and biocides, for example, benzene, chloroform, atrazine and permethrin.
Defines rules, also known as „Prior Information Consent“
2 rules: export notification and explicit consent.
Sharing of responsibility in international movement of dangerous chemicals
PIC = sharing the information on toxic chemicals and awaiting of consent from the state before export/import of the product

8. Accidents prevention Seveso Directive (82/501/EEC) Goal
Already version Seveso III
more than industrial establishments in the EU
where dangerous substances are used or stored in large quantities, mainly in the chemical and petrochemical industry
Goal
Prevent serious accidents (fires, explosions..)
Reduce consequences
Reporting on safety, elaboration of accident plans, informing the public

9. Plant protection products
Regulation (EC) n. 1107/2009 on marketing PPP
Actually a package
Directive 2009/128/EC on sustainable usef of pesticides
Regulation (CEC) n. 1107/2009 on marketing the PPP
Regulation (EC) n. 1185/2009 on pesticide statistics
Air deployment is forbidden in general, in areas close to inhabited areas is forbidden totally
Regulation contains a list of approved “active substances” on EU level.
ON national level, PPP are authorised based on the list
EU is divided in 3 zones : North, Central and South – mutual recognition is the key

10. Biocides Regulation (EU) n. 528/2012 Goal Relatively young, from 2013
Products and families are authorised on national or EU level, mutual recognition applies
BP require an authorisation before they can be placed on the market
Active substances in that biocidal product must be previously approved
Goal
Simplify the mechanism of authorisation and strengthen the role of ECHA in the process of review of documentation based on stricter conditions
Restrict marketing of BPR – risk management for humans and environment

11. Detergents Regulation (EC) n. 648/2004 Development (2006, 2009, 2012)
Harmonise the requirements on biological degradability of surface-active substances
Restrictions and bans for SAS
Information that must be provided
Labelling of detergent components
Development (2006, 2009, 2012)
New test for biodegradability secure more protection for water environment
The extent was enlarged to all classes of surface active substances
Labelling of allergens (by EC n. 907/2006) and complete list of components must be provided to health protection authorities
Since June 30, 2013: ban of phosphates in washing products

12. POPs and others
Regulation EC n. 850/2004 Persistent organic pollutants
Substances who remain in environment for a long time due to their capability to resist to different forms of degradation (chemical, biological)
Due to food chain = bioaccumulation = may have negative influence on human health and environment
Pesticides (DDT), industrial substances (PCBs) and unwilling by products from industrial processes (dioxines, furans).
Asbestos
Fibre like material dangerous while inhaling, largely used for insulation in the past
Forbids mining and processing of asbestos, production of asbestos items
Mercury
Ban on export of Hg from EU + implementation of Minamata Convention

13. The definition of the legend (by Wikipedia)
Marathon is a long-distance race, completed by running, walking, or a run/walk strategy. There are also wheelchair divisions.
The marathon has an official distance of kilometres ( miles; 26 miles 385 yards), usually run as a road race.
The event was instituted in commemoration of the fabled run of the Greek soldier Pheidippides, a messenger from the Battle of Marathon to Athens, who reported the victory.