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Mar. 31 – Canada: Restricted Components Regulations

March 30th, 2008

From Canada’s Ministry of Natural Resources, and recently printed in the Canada Gazette. The full text of the regulations is available here. A few key details:

What it covers:

The following components of an explosive are prescribed for the purpose of the definition “restricted component” in section 2 of the Act:

(a) ammonium nitrate in solid form at a concentration between 28 and 34% nitrogen;

(b) hydrogen peroxide at a concentration of at least 30%, UN numbers: 2015 and 3149;

(c) nitromethane, UN number: 1261;

(d) potassium chlorate, UN number: 1485;

(e) potassium perchlorate, UN number: 1489;

(f) sodium chlorate in solid form, UN number: 1495;

(g) nitric acid at a concentration of at least 68%, UN numbers: 2031 and 2032;

(h) potassium nitrate, UN numbers: 1486 and 1499; and

(i) sodium nitrate in solid form, UN numbers: 1498 and 1499.

[Section 3 of the Act]

These components will no longer be available for sale in Canada:

No person shall sell a restricted component except in accordance with these Regulations.

[Section 4 of the Act]

Unless the seller is on the list of sellers of restricted components:

Only persons who are enrolled on the list of sellers of restricted components may sell a restricted component.

A person may be enrolled on the list of sellers by applying to the Chief Inspector using the form provided by the Minister. The application must include

(a) the applicant’s name, address, telephone number, facsimile number and e-mail address;

(b) the restricted components that the applicant intends to sell;

(c) the locations where restricted components are to be stored or sold, and the storage capacity at each location for each component; and

(d) the name, telephone number, facsimile number and e-mail address of a contact person for each location where the restricted component is to be stored or sold.

[Sections 5 and 6 of the Act]

There are some exceptions:

These Regulations do not apply to the sale of restricted components to laboratories that are a part of or affiliated with a

(a) post-secondary educational institution recognized by a province;

(b) hospital or health clinic; or

(c) federal or provincial government or government agency.

[Section 2 of the Act]

The restrictions on Ammonium Nitrate come into effect on June 1, 2008 and the restrictions on all other chemicals come into effect on March 1, 2009:

(1) These Regulations, other than Part 1, come into force on June 1, 2008.

(2) Part 1 comes into force on March 1, 2009.

[Section 36 of the Act

Note: Part 1 has the title SECURITY — RESTRICTED COMPONENTS OTHER THAN AMMONIUM NITRATE]

The above is just a few of the key points of the Regulations. Please refer to the full text – available here.

Mar. 31 – REACH: IUCLID 5 Pre-Registration Plug-in Available

March 30th, 2008

From the IUCLID5 website:

A plugin is an extension of the IUCLID 5 application. The pre-registration plugin adds the functionality of creating single and bulk pre-registration XML files in a format, which can be submitted to the European Chemicals Agency. You need to install the IUCLID 5 application in order to make use of this software.

With the pre-registration plugin you will be able to enter the required data, or extract the available information relevant for pre-registration, from your existing IUCLID 5 data sets. You will also be able to pre-register multiple substances under certain conditions.

If you have more than a few substances to pre-register we would recommend you using this plugin for preparing your pre-registration.

Nexreg has more information on REACH at the following link:

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Non-Toll Free: (519)488-5126 (London, ON, Canada)
E-mail:info@nexreg.com

Mar. 31 – Canada: NHPD Adds Three New Monographs

March 30th, 2008

From Health Canada – three new Natural Health Products monographs:

Nexreg provides government registration services – for more information see: Government Registrations.

To speak to a Nexreg representative about government registrations, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

Mar. 31 – Print industry at risk of REACH breach

March 30th, 2008

Another article of the “some industries are not prepared for REACH variety”. This one has to do with the printing industry. From Printweek.com:

“The printing industry is a relatively heavy user of chemicals in terms of the number of substances, because inks and printing agents are preparations using many different substances. If a chemical does not comply, then there is potentially a legal problem,” Taylor added. “It’s certainly a commercially risky situation.”…

The EU estimates that there are 30,000 substances on the European market manufactured in quantities of one tonne or more every year. The process of registering all of these at once would have been a huge task. So registration will take place over three phases spread over a period of 11 years.

However, substance manufacturers that do not pre-register their chemicals by the end of November this year, must fully register their substance on the 1 December or face breaching European law.

“The key thing is for downstream users such as printers to make sure their suppliers know the use that they put a particular chemical to,” Taylor said. “The critical issue to downstream users is to have effective dialogue with their suppliers. It’s about them feeling comfortable that they will comply.”

For the full article, click on the above link.

Mar. 31 – Prop 65: Changes Without Regulatory Effect

March 30th, 2008

The OEHHA has proposed some “changes without regulatory effect:

OEHHA is proposing to move the Proposition 65 regulations from Title 22 to Title 27 of the California Code of Regulations (CCR). In 1987 the original lead agency for implementation of Proposition 65 regulations was the Health and Welfare Agency. For this reason, the Proposition 65 regulations were placed in Title 22, together with other Health and Welfare regulations. In 1991, Governor Wilson designated OEHHA as the lead agency for Proposition 65 implementation when OEHHA and its parent entity, the California Environmental Protection Agency, were established. The regulations have remained in Title 22. Placing Proposition 65 regulations in Title 27, together with other environmental regulations, would facilitate future searches by stakeholders. This is a non-substantive renumbering process; no material changes will be made to the regulation as part of this action.

OEHHA is offering an opportunity for the public to comment on this proposed non-substantive change.

For more information, click on the above link.

Mar. 31 – Prop 65: No Significant Risk Level for Ethylbenzene

March 30th, 2008

A recent release from the OEHHA:

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to establish a specific regulatory level posing no significant risk for ethylbenzene and amend Title 22, California Code of Regulations, Section 12705(b)…

Any written statements or arguments regardless of the form or method of transmission must be received by OEHHA by 5:00 p.m. on May 12, 2008, which is hereby designated as the close of the written comment period.. .

This amendment to Section 12705(b) would adopt the following “no significant risk” levels for one chemical listed as known to cause cancer:

Chemical: Ethylbenzene (inhalation)

NSRL, in units micrograms per day: 54

Reference: OEHHA (2007, 2008)

Chemical: Ethylbenzene (oral)

NSRL, in units micrograms per day: 41

Reference: OEHHA (2007, 2008)

For the full details, click on the above link.

Mar. 31 – Prop 65: No Significant Risk Level for C.I. Direct Blue 218

March 30th, 2008

A recent release from the OEHHA:

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to establish a specific regulatory level posing no significant risk for C.I. Direct Blue 218 and amend Title 22, California Code of Regulations., Section 12705(b)…

This amendment to section 12705(b) would adopt the following No Significant Risk Level (NSRL) for one chemical listed as known to cause cancer:

Chemical: C.I. Direct Blue 218

NSRL, in units micrograms per day: 50

Reference: OEHHA (2008)

For the full details, click on the above link.

Mar. 24 – EU REACH: Chemical Shake-Up

March 24th, 2008

An excellent introductory article on REACH in Guardian Unlimited:

The lack of awareness in this case pertains to the Reach chemicals legislation (all 850 pages of it). Reach stands for the far less punchy “Registration, Evaluation, Authorisation and Restriction of Chemicals”. These regulations are considerably more interesting than they sound, having been described as the most complex piece of legislation in the history of the European Union, and the most important in 20 years.

In brief, Reach requires (pdf) all chemicals of one tonne or more in volume that are manufactured in or imported into the European Union to be tested for health and safety. They must also be registered with a new, central European authority – namely, the European Chemicals Agency in Helsinki, Finland. It is, unsurprisingly, the strictest law to date regulating chemical substances.

Nexreg has more information on REACH at the following links:

To speak to a Nexreg representative about how REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
Nexreg Canada: (519)488-5126 (London, ON)
Nexreg UK: +44 020 7993 5893 (London, UK)
Nexreg USA: (206)418-6663 (Seattle, WA)
E-mail:info@nexreg.com

Mar. 19 – Canada: Regulations Amending the Patented Medicines Regulations, 1994

March 19th, 2008

A large number of changes, as listed in Regulations Amending the Patented Medicines Regulations, 1994 – click on the link to see the full amendment.

Mar. 19 – Canada: Additions to DSL

March 19th, 2008

From Order 2007-66-12-01 Amending the Domestic Substances List :

AMENDMENT

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

1344-57-6

7783-81-5

102424-23-7

Further additions with: Order 2007-87-12-01 Amending the Domestic Substances List:

Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

2164-17-2 N

70880-56-7 N-P

81565-33-5 N-P

94095-35-9 N

117454-92-9 N-P

148878-27-7 T-P

173521-40-9 N-P

868839-23-0 N

2. Part 3 of the List is amended by adding the following in numerical order:

17704-1 N-P

2-Propenoic acid, 2-methyl-, polymer with alkyl 2-methyl-2-propenoate, cyclohexyl 2-methyl-2-propenoate, ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-methyl-2-propenoate and a-(2-methyl-1-oxo2-propenyl)-?-methoxypoly(oxy-1,2-ethanediyl), compound with 2-(dimethylamino)ethanol

17831-2 N-P

2-Propenoic acid, 2-methyl-, polymer with alkyl 2-methyl-2-propenoate, butyl 2-propenoate, 1,2-ethanediyl bis(2-methyl-2-propenoate), 2-hydroxyethyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-propenoate, methyl 2-methyl-2-propenoate and 2-propenamide, compound with 2-(dimethylamino)ethanol

17864-8 N-P

Hexanedioic acid, polymer with 2-butyl-2-ethyl-1,3-propanediol, carbomonocycle dicarboxylic acid, 2-ethyl2-(hydroxymethyl)-1,3-propanediol, hexahydro-1,3-isobenzofurandione and 3-methyl-1,5-pentanediol, dihydrogen 1,2,4-benzenetricarboxylate, compound with 2-(dimethylamino)ethanol

17865-0 N-P

Hexanedioic acid, polymer with 2-butyl-2-ethyl-1,3-propanediol, carbomonocycle dicarboxylic acid, 2,2-dimethyl-1,3-propanediol, and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, dihydrogen 1,2,4-benzenetricarboxylate, compound with 2-(dimethylamino)ethanol

17866-1 N-P

2-Propenoic acid, 2-methyl-, methyl ester, polymer with alkyl 2-propenoate, ethenylbenzene, 1,6-hexanediol di-2-propenoate and 2-hydroxyethyl 2-propenoate

17867-2 N-P

Hexanedioic acid, polymer with 2-butyl-2-ethyl-1,3-propanediol, carbomonocycle dicarboxylic acid, 2-ethyl2-(hydroxymethyl)-1,3-propanediol and 3-methyl-1,5-pentanediol, dihydrogen 1,2,4-benzenetricarboxylate, compound with 2-(dimethylamino)ethanol

For more information click on the respective links.