turizm - bursa §evre d¼zeni plan±
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EHS and Product Regulatory July/August 2013 EU News Digest A selection of headlines in the areas of chemicals, environment, consumer products and occupational safety regulations over the past months. Highlights of the month BELGIUM NOTIFIES DRAFT NANO DECREE TO THE COMMISSION Belgium notified its draft “Royal Decree regarding the placement on the market of substances manufactured at the nanoscale” to the Commission on 4 July 2013 (Notification No 2013/369/B). The draft Decree is close to the French regulatory framework for the registration of nanomaterials which became applicable this past June, with several key differences. The draft decree establishes a mandatory premarket declaration requirement for the placing on the market above a threshold of 100 g of substances intentionally manufactured at the nanoscale, either as such or in preparations, and either produced directly by the person placing them on the market or transferred to professional users. The declaration is to be submitted electronically to the Ministry of Public Health prior to the placing on the market (a key difference with the French system), and must then be updated by 31 March of the following year. The declara- tion must contain information on the declarer, the substance identity, the quantity placed on the market during the reporting period, the uses of the substance or preparation, and the identity of the professional users to whom the products were transferred. The declarer will then receive a unique declaration number that must be communicated to professional users. The definition of nanoscale substances is based on the harmonized definition of Commission Recommendation 2011/696/EU. However, and this constitutes another key difference with the French framework, the draft decree includes a sizable list of products exempted from the Decree, including cosmetic products, biocides and treated articles, human and veterinary medicinal products, food, feed and processing aids covered by harmonized EU law; the decree also exempts pigments in preparations and articles. The Decree also provides a simplified declaration procedure for substances and preparations used only for the purpose of research and development, as well as for those that would already have been the subject of a similar declaration to a foreign national authority with whom mutual recognition agreements are in place. The Belgian decree also distinguishes its future framework from its French equivalent by establishing a separate premarket notification requirement for nanoscale substances incorporated into articles. A notification must be submitted prior to the placing on the market of articles containing nanoscale substances if it cannot be excluded that at least 0.1% of the initial mass of these substances will be discharged under appropriate and reasonably foreseeable use. Articles containing nanoscale substances in a suspended state, incorporated in any phase other than the solid phase, or incorporated into a surface expected to come into contact with the user or to which humans can be indirectly exposed via the environment under reasonably foreseeable and appropriate use are automatically subject to notification. Notifications must include information on the declarer and the article, and identify the nanoscale substances incorporated into the article, their use and concentration (however no informa- tion is required concerning the identity of the professional users to whom the articles are transferred). The Decree also carves out a specific exemption from notification for articles containing carbon black, synthetic amorphous silica, or precipitated calcium carbonate as filler materials.
Transcript of turizm - bursa §evre d¼zeni plan±
EHS and Product RegulatoryJuly/August 2013
EU News DigestA selection of headlines in the areas of chemicals, environment, consumer products and occupational safety
regulations over the past months.
Highlights of the month
BELGIUM NOTIFIES DRAFT NANO DECREE TO THE COMMISSION
Belgium notified its draft “Royal Decree regarding the placement on the market of substances manufactured at the
nanoscale” to the Commission on 4 July 2013 (Notification No 2013/369/B). The draft Decree is close to the French
regulatory framework for the registration of nanomaterials which became applicable this past June, with several
key differences.
The draft decree establishes a mandatory premarket declaration requirement for the placing on the market above a
threshold of 100 g of substances intentionally manufactured at the nanoscale, either as such or in preparations, and
either produced directly by the person placing them on the market or transferred to professional users. The
declaration is to be submitted electronically to the Ministry of Public Health prior to the placing on the market (a
key difference with the French system), and must then be updated by 31 March of the following year. The declara-
tion must contain information on the declarer, the substance identity, the quantity placed on the market during the
reporting period, the uses of the substance or preparation, and the identity of the professional users to whom the
products were transferred. The declarer will then receive a unique declaration number that must be communicated
to professional users.
The definition of nanoscale substances is based on the harmonized definition of Commission Recommendation
2011/696/EU. However, and this constitutes another key difference with the French framework, the draft decree
includes a sizable list of products exempted from the Decree, including cosmetic products, biocides and treated
articles, human and veterinary medicinal products, food, feed and processing aids covered by harmonized EU law;
the decree also exempts pigments in preparations and articles. The Decree also provides a simplified declaration
procedure for substances and preparations used only for the purpose of research and development, as well as for
those that would already have been the subject of a similar declaration to a foreign national authority with whom
mutual recognition agreements are in place.
The Belgian decree also distinguishes its future framework from its French equivalent by establishing a separate
premarket notification requirement for nanoscale substances incorporated into articles. A notification must be
submitted prior to the placing on the market of articles containing nanoscale substances if it cannot be excluded
that at least 0.1% of the initial mass of these substances will be discharged under appropriate and reasonably
foreseeable use. Articles containing nanoscale substances in a suspended state, incorporated in any phase other
than the solid phase, or incorporated into a surface expected to come into contact with the user or to which
humans can be indirectly exposed via the environment under reasonably foreseeable and appropriate use are
automatically subject to notification. Notifications must include information on the declarer and the article, and
identify the nanoscale substances incorporated into the article, their use and concentration (however no informa-
tion is required concerning the identity of the professional users to whom the articles are transferred). The Decree
also carves out a specific exemption from notification for articles containing carbon black, synthetic amorphous
silica, or precipitated calcium carbonate as filler materials.
The Decree would operate as an information gathering tool for Belgian authorities, as declarers and notifiers alike
would be subject to a general obligation to provide, when requested, all information at their disposal on potential
hazards of and exposure to the nanoscale substances they placed on the market, as well as any other information
relevant to the assessment of risks they would represent to human health.
The Standstill Period for the draft decree (the period during which Other Member States can submit comments)
ends on 7 October 2013, after which Belgium would be free to adopt the Decree. The Decree is set to apply from 1
January 2015 for declarations of nanoscale substances supplied as such, and from 1 January 2016 for the declara-
tion of nanoscale substances in preparations and the notification of nanoscale substances in articles.
STRICTER REQUIREMENTS FOR CHEMICAL SUBSTANCES IN TOYS BECOME APPLICABLE FROM 20 JULY 2013
More stringent requirements concerning chemical requirements for toys became applicable this summer.
First, the last part of the Toy Safety Directive 2009/48/EC (TSD) that was not yet applicable under the transition
period from the old Toy Safety Directive 88/378/EEC, namely Annex II part III establishing requirements for
chemical properties of toys, became applicable on 20 July 2013. This is the (key) part of the TSD that establishes
stringent new requirements for the use in toys of substances classified as carcinogenic, mutagenic or toxic for
reproduction (“CMR substances”), and that provides a black list of allergenic fragrances banned from use in toys,
as well as migration limits for an extended list of chemical substances such as heavy metals.
In parallel to the expiration of the above transition period and the now full applicability of the TSD, the
Commission also adopted a new amendment to the Directive, Commission Regulation (EU) No 681/2013. We
previously reported on the Commission proposal for this measure in our April issue, when the draft measure was
published. Regulation (EU) No 681/2013 divides by 3 migration limits initially set for barium under Annex II Part
III of the TSD based on the conclusions of a March 2012 opinion of the Scientific Committee on Health and
Environmental Risks (SCHER) which recommended a similar reduction of the tolerable daily intake for barium
from 0.6 to 0.2 mg/kg body weight/day taking into account US data published by the US Agency for Toxic
Substances and Disease Registry. This is the second amendment to the TSD after the adoption of Directive 2012/7/
EU last year which had already reduced applicable migration limits for cadmium in the TSD under Annex II Part
III. Regulation 681/2013 and updated migration limits for barium (and cadmium) enter into force on 20 July 2013,
on the date of full entry into force of the chemical requirements of the TSD.
BPA STILL UNDER SCRUTINY, NO IMMEDIATE EU ACTION PLANNED
Bisphenol A (BPA) continues to face intense scrutiny as France submitted a proposal to amend the current classifi-
cation and labeling of BPA from reproductive toxicity category 2 to category 1B on 27 August 2013. ECHA has
invited all interested parties to provide comments on this proposal within the framework of a public consultation
that will end on 11 October 2013 .
In the meantime the European Food Safety Authority (EFSA) published 2013 a draft opinion on consumer expo-
sure to BPA on 25 July 2013. The draft report, which was open to public consultation until 15 September 2013,
confirms that food -and food packaging- are the main sources of consumer exposure to BPA. A second consultation
to focus on assessment of the risks to human health presented by BPA is still scheduled for early 2014, and EFSA’s
final reevaluation for mid-2014.
Importantly, the Commission has confirmed that it will wait for the issuance of EFSA’s final opinion before consid-
ering any revision to the status of BPA under EU food contact legislation in a written answer provided by Tonio
Borg, Commissioner for Health, to a Parliamentary question from Asa Westlund (link to Food Contact 02.07
news).
NEW COSMETICS REGULATION BECOMES FULLY APPLICABLE
The new Cosmetics Regulation (EC) No 1223/2009 became fully applicable on 11 July 2013. While its new stringent
rules on the use of CMR substances in cosmetics became applicable on 1 December 2010, and new requirements
concerning the premarket notification of nanomaterials used in cosmetics became applicable on 11 January 2013,
the bulk of the new Regulation was still on hold and economic operators were still operating under the framework
of the old Directive 76/768/EEC. The old Directive is now officially repealed with effect from 11 July 2013, and all
provisions of Regulation 1223/2009, including new notification and labeling requirements, are now fully
enforceable.
We note that in parallel to the end of the transition period discussed above, the Commission also adopted
Regulation (EU) No 658/2013 this summer which incorporates a number of entries to Annexes II (prohibited
substances) and III (substances subject to restrictions) of the Cosmetics Regulation for hair dye substances that
were introduced into Annexes II and III of the old Directive after the adoption of Regulation (EU) No 1223/2009.
This Amendment is applicable as of 1 September 2013.
BIOCIDAL PRODUCTS REGULATION BECOMES APPLICABLE
Regulation (EU) No 528/2012, known as the biocidal products regulation (BPR), became applicable and officially
repealed the old Biocidal Products Directive (BPD) 98/8/EC as of 1 September 2013. The BPR introduces scores of
new requirements into the regulatory framework for biocidal products, including new procedures for EU approval
of biocidal products, far reaching mandatory data sharing provisions (see our Legal Update on data sharing issues
under the BPR for more details), legal update in new requirements for treated articles (see our January Legal
Spotlight on treated articles for more details), a system of approved active substance suppliers, and the use of a new
IT-platform for the submission of applications under the new regulatory framework (known as the Registry for
Biocidal Products, “R4BP 3”). While some transitional provisions remain, notably for treated articles, the entry into
application of the BPR represents a major milestone in EU legislation.
The European Chemicals Agency (ECHA) has published numerous guidance documents during the past months to
assist economic operators navigating these new requirements, including guidelines on information requirements
and on active substance suppliers, as well as guidelines on applications for technical equivalence (link to 21.08
news). A number of other guidance documents (“submission manuals”) dedicated to the numerous uses of the new
R4BP 3 IT-platform have been issued by ECHA and are available on its website.
Contents
CHEMICALS/REACH/CLP 1
COSMETICS 2
ENVIRONMENT 2
ENERGY 2
FOOD 3
FEED 4
FOOD CONTACT MATERIALS 4
GENERAL PRODUCT SAFETY 5
NANOTECHNOLOGY 5
PESTICIDES / BIOCIDES / PESTICIDE RESIDUES 5
OCCUPATIONAL SAFETY 7
TOYS 7
MAYER BROWN PRODUCT REGULATORY NEWS & EVENTS 7
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CHEMICALS/REACH/CLP
Date Title
05.07.2013 ECHA - Call for further evidence on the use of cadmium-based pigments in plastics
05.07.2013 Guidance for Suppliers of Articles - The REACH duties to inform about Candidate List substances
10.07.2013 Consultative Communication on the Sustainable Use of Phosphorus
15.07.2013 EFSA - Assessing “chemical mixtures” – current approaches and future priorities
15.07.2013 EFSA - International Frameworks Dealing with Human Risk Assessment of Combined Exposure to Multiple
Chemicals
18.07.2013 ECHA and stakeholders set out actions to improve chemical safety reports and safety data sheets (See the
Roadmap and Roadmap implementation plan)
19.07.2013 Sweden proposes cadmium in paints for restriction
24.07.2013 UK Defra - Consultation on the Marketing and Use of Second-Hand Articles containing Asbestos
25.07.2013 ECHA - Guidance on safety data sheets
25.07.2013 ECHA - Guidance for downstream users
25.07.2013 ECHA - Guidance on CLP criteria
01.08.2013 The Board of Appeal annuls an ECHA decision
ECHA loses compliance check case in Board of Appeal Decision
01.08.2013 Identification of potential PBT/vPvB-Substances by QSAR methods (See UBA Study)
02.08.2013 ECHA will submit a restriction proposal for bis(pentabromophenyl) ether (decaBDE)
03.08.2013 ECHA has published a corrigendum to the guidance on information requirements and chemical safety
assessment
07.08.2013 Draft Commission Regulation (EU) amending Annex XVII to Regulation (EC) No 1907/2006 on the REACH
as regards Polycyclic aromatic hydrocarbons
07.08.2013 JRC - The EURL ECVAM is inviting public comments on its latest Recommendations concerning 2 alternative
test methods. Deadline for comments: 13th September 2013
10.08.2013 Commission Regulation (EU) No 758/2013 of 7 August 2013 correcting Annex VI to Regulation (EC) No
1272/2008 on classification, labelling and packaging of substances and mixtures
10.08.2013 ECHA - The Netherlands has re-submitted a restriction proposal for 1-methyl-2-pyrrolidone (NMP),
20.08.2013 France: consultation on endocrine disrupting chemicals
21.08.2013 ECHA consults on CLH proposal for chlorobenzene
22.08.2013 CLP fourth draft guidance sent to Caracal
24.08.2013 Directive 2013/39/EU of 12 August 2013 amending Directives 2000/60/EC and 2008/105/EC as regards
priority substances in the field of water policy
26.08.2013 Agenda of the REACH Committee meeting of 17 & 18 September 2013
26.08.2013 Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 on the REACH as
regards chromium VI compounds
27.08.2013 EU Commission to hold SME REACH workshop
27.08.2013 ECHA - Public consultation launched on a proposal for revision of the harmonised classification and labelling
on bisphenol A
30.08.2013 ECHA - Consultations on draft review report on phthalates DINP and DIDP
http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/call-for-comments-on-two-eurl-ecvam-recommendations
2 Eu News Digest
COSMETICS
Date Title
05.07.2013 “SEURAT-1 meets Tox21”: international cooperation in safety assessment of chemicals using animal-free
methods
11.07.2013 New Cosmetics Regulation 1223/2009 enters into force. (IP/13/677 & -Commission Regulation (EU) No
655/2013)
11.07.2013 Commission Regulation (EU) No 658/2013 of 10 July 2013 amending Annexes II and III to Regulation (EC) No
1223/ 2009 on cosmetic products
16.07.2013 Memorandum on Scientific Evaluations and Opinions to be adopted by the SCCS
18.07.2013 Draft Commission Regulation (EU) amending Annex III to Regulation (EC) No 1223/2009 on cosmetic
products
26.07.2013 Scientific Committee on Consumer Safety publishes 3 opinions on cosmetic ingredients in nanoform:
• Opinion on Titanium Dioxide (nano form)
• Addendum to the opinion SCCS/1489/12 on Zinc oxide (nano form)
• Revision of the opinion on 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)
phenol) nano form
ENVIRONMENT
Date Title
02.07.2013 Commission publishes the revised RoHS methodology manual
11.07.2013 Proposal for a Regulation of the European parliament and of the Council amending Regulation (EC) No
1013/2006 on shipments of waste
12.07.2013 Draft - Commission Regulation amending Regulation (EC) No 1005/2009 with regard to reporting on methyl
bromide
22.07.2013 European Environmental Bureau sends comments on RoHS 2 Directive to Commissioner Potočnik
16.08.2013 Institute for European Environmental Policy- Report on the influence of EU policies on the environment
23.08.2013 UK releases a summary of responses to consultation on the revised waste electronic and electrical equipment
(WEEE) Directive
27.08.2013 Stakeholder consultation on exemptions from the substance restrictions in electrical and electronic equipment
(RoHS Directive)
28.08.2013 New Directive 2013/39/EU of the European Parliament and the Council of 12 August 2013 amending Directives
2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy
28.08.2013 Publication of Revised RoHS methodology Manual by Austrian Environment Agency (see Manual and
stakeholder comments from 3rd internet consultation)
ENERGY
Date Title
11.07.2013 “Biofuels should deliver greenhouse gas emission cuts and not compete with food” (See the EP Statement)
11.07.2013 Environment Committee advocates promoting advanced biofuels (See the EP Statement)
18.07.2013 Proposal for a Directive of the European Parliament and of the Council amending Directive 98/70/EC relating
to the quality of petrol and diesel fuels and amending Directive 2009/28/EC on the promotion of the use of
energy from renewable sources (first reading – Agenda ILUC meeting on 23.07.2013)
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FOOD
Date Title
04.07.2013 EU proposal for a review of Official Controls – BEUC comments
05.07.2013 Horse meat: final report on FSA response
09.07.2013 EFSA pilot project on the implementation of FoodEx2 as part of the Standard Sample Description for the
electronic transmission of harmonised chemical occurrence data to EFSA - NP/EFSA/DCM/2012/01/04
09.07.2013 EFSA - Project ‘Risk categorisation for Aquatic Animal Health Surveillance’ (CFP/EFSA/AHAW/2011/03)
10.07.2013 Answer by Mr Borg to EP Question on Amendment to Commission Regulation (EU) No 1129/2011 regarding
the food additives list
15.07.2013 What future for our food system? Let us know what you think (IP/13/688)
16.07.2013 Acrylamide in food – EFSA to publicly consult on draft opinion in 2014
18.07.2013 Draft Commission Regulation amending Regulation (EU) No 432/2012 establishing a list of permitted health
claims made on foods other than those referring to the reduction of disease risk and to children’s development
and health
18.07.2013 Draft Commission Regulation refusing to authorise certain health claims made on foods, other than those
referring to the reduction of disease risk and to children’s development and health
24.07.2013 SCFCAH - Toxicological Safety of Food Chain Summary record of the meeting of 01 July 2013
24.07.2013 Draft Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 as regards the use of
Diphosphates (E450), Triphosphates (E451) and Polyphosphates (E452) in wet salted fish
24.07.2013 Draft Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 as regards the use of
sodium phosphates (E 339) in natural casings for sausages
31.07.2013 Commission Regulation (EU) No 739/2013 of 30 July 2013 amending Annex II to Regulation (EC) No
1333/2008as regards the use of Stigmasterol-rich plant sterols and the Annex to Commission Regulation (EU)
No 231/2012 as regards specifications for Stigmasterol-rich plant sterols food additive
31.07.2013 EFSA issues guiding principles for two-year whole food studies
31.07.2013 Germany - Seventh Order amending the Order on the marketing of additives
31.07.2013 Draft Commission Regulation amending Annex I to Regulation (EC) 1334/2008 as regards certain flavouring
substances
01.08.2013 EFSA - Opinion on Priority topics for the development of risk assessment guidance by EFSA’s Scientific
Committee
07.08.2013 Draft proposal for a Council Regulation laying down maximum permitted levels of radioactive contamination of
food and feed following a nuclear accident or any other case of radiological emergency
09.08.2013 Hungary - Decree of the Minister of Rural Development on medicinal plants (herbs) that may be marketed as
food or food ingredient
13.08.2013 EFSA - Public Consultation on the Draft Guidance on Expert Knowledge Elicitation in Food and Feed Safety
Risk Assessment
21.08.2013 Draft Commission Regulation amending Regulation (EU) 1169/2011 on the provision of food information to
consumers as regards information on the absence or reduced presence of gluten in food
22.08.2013 Commission Regulation amending Annexes II and III to Regulation (EC) 1333/2008 and the Annex to
Commission Regulation (EU) 231/2012 as regards certain food additives
4 Eu News Digest
FEED
Date Title
03.07.2013 EFSA – Agenda of 97th plenary meeting of the FEEDAP Panel on 9 July 2013
05.07.2013 Commission Regulation (EU) No 642/2013 of 4 July 2013 concerning the authorisation of niacin and
niacinamide as feed additives for all animal species
05.07.2013 Commission Regulation (EU) No 643/2013 of 4 July 2013 concerning the authorisation of Patent Blue V as a
feed additive for non-food producing animals and amending Regulation (EC) No 358/2005
10.07.2013 Commission Implementing Regulation (EU) No 651/2013 of 9 July 2013 concerning the authorisation of
clinoptilolite of sedimentary origin as a feed additive and amending Regulation (EC) No 1810/2005
12.07.2013 Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of
diclazuril as a feed additive for chickens and repealing Regulation (EC) No 162/2003
27.07.2013 Commission Regulation (EU) No 725/2013 of 26 July 2013 concerning the authorisation of ammonium chloride
as a feed additive for ruminants, cats and dogs (holder of the authorisation BASF SE)
21.08.2013 Commission Regulation (EU) No 795/2013 of 21 August 2013 concerning the authorisation of choline chloride
as a feed additive for all animal species
21.08.2013 Commission Regulation (EU) No 796/2013 of 21 August 2013 concerning the denial of authorisation of the
substance 3-acetyl-2,5-dimethylthiophene as a feed additive
21.08.2013 Commission Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation
of Enterococcus faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned
piglets (holder of authorisation Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004
FOOD CONTACT MATERIALS
Date Title
02.07.2013 Commission confirms no action planned on possible BPA ban before publication of EFSA opinion in response to
Parliamentary Question (see Question, and Answer)
04.07.2013 Danish EPA publishes national phthalate strategy
05.07.2013 Sweden takes first steps to phase out phthalates (See Swedish Chemical Agency press release)
25.07.2013 EFSA - Opinion on “Visy” and “SIA EkoPET” PET recycling processes based on Starlinger IV+ (R) technology
25.07.2013 EFSA - Opinion on “INTERSEROH Step 2” process for recycling of polypropylene crates
25.07.2013 EFSA draft opinion indicates food is main source of BPA exposure for consumers, thermal paper also potentially
significant (see EFSA press release)
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GENERAL PRODUCT SAFETY
Date Title
05.07.2013 Weekly overview report of RAPEX notifications - Report 26/2013
12.07.2013 Weekly overview report of RAPEX notifications - Report 27/2013
19.07.2013 Weekly overview report of RAPEX notifications - Report 28/2013
26.07.2013 Weekly overview report of RAPEX notifications - Report 29/2013
31.07.2013 RAPEX notifications (monthly reports) January-June 2013
22.08.2013 Weekly overview report of RAPEX notifications - Report 30/2013
09.08.2013 Weekly overview report of RAPEX notifications - Report 31/2013
12.08.2013 Minutes of the 2nd Plenary Meeting of the SCENIHR of 25 June 2013
13.08.2013 SCHER - Minutes of the 2nd plenary meeting, Luxembourg, 28 June 2013
16.08.2013 Weekly overview report of RAPEX notifications - Report 32/2013
23.08.2013 Weekly overview report of RAPEX notifications - Report 33/2013
NANOTECHNOLOGY
Date Title
10.07.2013 Belgium has notified EU Commission of nano register plan
10.07.2013 Danish Environmental Protection Agency (EPA) has launched a public consultation on nanomaterials (See the
Draft statutory order (Danish), the Public consultation (Danish), and the Public hearing letter (Danish)
26.07.2013 Scientific Committee on Consumer Safety publishes 3 opinions on cosmetic ingredients in nanoform (see
Cosmetics section)
10.08.2013 Commission Report: Nanotechnology: the invisible giant tackling Europe’s future challenges
PESTICIDES / BIOCIDES / PESTICIDE RESIDUES
Date Title
05.07.2013 Pesticides and bees: EFSA finalises new guidance (Statement)
05.07.2013 EFSA - Outcome of the 1st Round the 2nd Round of Public Consultation on the draft Guidance Document on
the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees)
12.07.2013 EFSA - Scientific support for preparing an EU position for the 45th Session of the Codex Committee on
Pesticide Residues (CCPR)
15.07.2013 Commission Regulation (EU) No 668/ 2013 of 12 July 2013 amending Annexes II and III to Regulation (EC)
No 396/2005 as regards MRLs for 2,4-DB, dimethomorph, indoxacarb, and pyraclostrobin in or on certain
products
15.07.2013 EFSA - Opinion on the identification of pesticides to be included in cumulative assessment groups on the basis
of their toxicological profile
15.07.2013 EFSA presents cumulative assessment group methodology for pesticides
16.07.2013 Bee Health: EU takes additional measures on pesticides to better protect Europe’s bees (IP/13/708)
16.07.2013 ECHA publishes two new Guidance documents on information requirements for biocides and on active
substance suppliers
24.07.2013 ECHA - Use IUCLID to prepare your summary of biocidal product characteristics
25.07.2013 EFSA consults on draft guidance for evaluating studies to measure pesticide degradation time in soil
6 Eu News Digest
Date Title
31.07.2013 Plant health: EFSA consults on citrus canker and citrus black spot
31.07.2013 Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) No 528/2012
as regards the duration of the work programme for examination of existing biocidal active substances
07.08.2013 SCHER - Minutes of Working Group Meeting on Calcium Cyanamide – fertiliser of 27 June 2013
12.08.2013 Summary record - meeting of 12/07/2013 of the Standing Committee on Biocidal Products
19.08.2013 Commission Regulation (EU) No 777/2013 of 12 August 2013 amending Annexes II, III and V to Regulation
(EC) No 396/2005 as regards MRLs for clodinafop, clomazone, diuron, ethalfluralin, ioxynil, iprovalicarb,
maleic hydrazide, mepanipyrim, metconazole, prosulfocarb and tepraloxydim in or on certain products
20.08.2013 Commission Implementing Regulation (EU) No 790/2013 of 19 August 2013 amending Implementing
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance acetic acid
21.08.2013 ECHA publishes technical equivalence guidance for biocides
21.08.2013 Commission Implementing Regulation (EU) No 798/2013 of 21 August 2013 amending Implementing
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins
22.08.2013 EFSA Info Session on Applications – Workshop with Member States, applicants and stakeholders on EFSA
Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp.
and solitary bees) on 9 September 2013
23.08.2013 Commission Implementing Regulation (EU) No 802/2013 of 22 August 2013 approving the active substance
fluopyram, in accordance with Regulation (EC) No 1107 /2009 concerning the placing of plant protection
products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540 /2011
29.08.2013 Sweden (Kemi) wants Nordic cooperation on antimicrobial treated articles: PM 2/12 Biocide treated articles
– an Internet survey, PM 10/12 Biocide treated articles – assessing knowledge levels & PM 1/12 Antibacterial
substances leaking out with the washing water
30.08.2013 Commission Implementing Regulation (EU) No 826/2013 of 29 August 2013 approving the active substance
sedaxane
30.08.2013 Commission Implementing Regulation (EU) No 827/2013 of 29 August 2013 approving the active substance
Aureobasidium pullulans (strains DSM 14940 and DSM 14941)
30.08.2013 Commission Implementing Regulation (EU) No 828/2013 of 29 August 2013 approving the active substance
emamectin
30.08.2013 Commission Implementing Regulation (EU) No 829/2013 of 29 August 2013 approving the active substance
Pseudomonas sp. strain DSMZ 13134
30.08.2013 ECHA - New Biocidal Products Regulation enters into operation on 1 September 2013
31.08.2013 Commission Implementing Regulation (EU) No 832/2013 of 30 August 2013 approving the active substance
disodium phosphonate
31.08.2013 Commission Implementing Regulation (EU) No 833/2013 of 30 August 2013 approving the active substance
pyriofenone
31.08.2013 Commission Regulation (EU) No 834/ 2013 of 30 August 2013 amending Annexes II and III to Regulation
(EC) No 396/2005 as regards MRLs for acequinocyl, bixafen, diazinon, difenoconazole, etoxazole, fenhexamid,
fludioxonil, isopyrazam, lambda-cyhalothrin, profenofos and prothioconazole in or on certain products
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OCCUPATIONAL SAFETY
Date Title
12.07.2013 EU-OSHA: E-fact 75: Dangerous substances and successful workplace communication
28.08.2013 ANSES - France examines limit values for chemicals used in the workplace
TOYS
Date Title
11.07.2013 Summary report of the Safety of toys Committee Meeting of 03 May 2013
18.07.2013 Commission Regulation (EU) No 681/2013 of 17 July 2013 amends Directive 2009/48/EC to reduce migration
limits for barium in toys
20.07.2013 Chemical requirements of new Toy Safety Directive become applicable (see TIE press release )
08.08.2013 Scientific Committee on Health and Environmental Risks (SCHER) - Request for an opinion on Chromium VI
in toys
20.08.2013 ETAD recommendation for “TOTAL” element limits for organic pigment products sold into toys
MAYER BROWN PRODUCT REGULATORY NEWS & EVENTS
Date Title
03.09.2013 Legal Update: Biocides: Get ready for data sharing and letters of access requests under the BPR
04.09.2013 Jean-Philippe Montfort’s presentation on legal aspects of Substance and Dossier Evaluation under REACH
(Informa Chemical Industries Regulations Conference, Barcelona)
0175bruSeptember 2013
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