Valuable resources for regulatory professionals

3E actively and proudly provides a variety of resources to the EHS community to inform regulatory professionals on the latest issues and topics affecting the EHS profession. The Resource Center is designed to help the community identify best practices for managing compliance information. This is where we also share our knowledge on new and changing standards and regulations.

Visit the Resource Center often for the latest information about 3E's involvement in the industry.

The FDA Issues an Updated Draft GMP Guidance for Cosmetics

July 10, 2013Mujadala Abdul-Majid

The Food and Drug Administration (FDA) on 25 June 2013 published revisions to a draft guidance on good manufacturing practices (GMPs) for cosmetic products. The guidance is to share the FDA’s current thinking concerning what constitutes GMPs for cosmetics.

Updates: FDASIA and Drug Supply Chain Compliance Matters

July 8, 2013Mujadala Abdul-Majid

The Food and Drug Administration Safety Innovation Act (FDASIA) introduces for the first time a legal requirement for manufacturers to be accountable for their suppliers as a part of current Good Manufacturing Practice (cGMP).

New ENERGY STAR Specs for Residential Refrigerators and Freezers

July 2, 2013Kirsten Wallerstedt

The ENERGY STAR product labeling program, which began in 1992, helps U.S. consumers, businesses, utilities, and government agencies to identify more efficient products that lower their energy costs. It is jointly administered by EPA and the Department of Energy (DOE), with EPA as the lead agency.

EP Committee Members Strike Deal on Product Directives

June 11, 2013Kirsten Wallerstedt

Members of the European Parliament (EP) Committee on the Internal Market announced that they struck a deal to update eight product safety directives, including on electrical equipment, phones, and irons, as well as professional products including explosives.

Korean Legislature Adopts K-REACH

June 6, 2013Sookie Hong and Kirsten Wallerstedt

K-REACH, which becomes effective 1 January 2015, introduces significant changes to South Korea’s chemicals management framework, including an annual reporting requirement on quantities and uses of all manufactured and imported chemicals.

No Hints Dropped in California’s Economic Assessment of the Safer Products Law

May 31, 2013Kirsten Wallerstedt

California’s Safer Consumer Products (SCP) regulations recently underwent the required economic impact analysis in order to complete the Economic and Fiscal Impact Statement (Notice File Number Z 2012-0717-04).

The FDA Considers How Best to Weather Risks in the Medical Device Supply Chain

May 16, 2013Mujadala Abdul-Majid

While the Security Exchange Commission and international regulatory bodies, such as the Organization for Economic Cooperative Development (OECD), have been uncharacteristic drivers of upstream supply chain compliance issues affecting the sourcing of medical device materials, public health regulatory agencies are deliberating over downstream concerns of “critical” medical device product shortages.

EU and Canada Consider Conflict Minerals Rules

April 4, 2013Kirsten Wallerstedt

The European Union and Canada may soon join the United States in requiring certain companies to perform due diligence to investigate whether minerals that are used in their products originated in conflict-affected or high-risk areas.

Reviewing 2012 and Looking Forward to the New Year

January 16, 2013David Don

Through the various regional Environmental Health & Safety (EH&S) Conferences I attended in 2012 – which included Kentucky, Virginia, Ohio, Maryland and Pennsylvania – there were some themes and comments from the many talented EH&S professionals I encountered.

Conflict Minerals Disclosure Rule May Be Reviewed by the U.S. Court of Appeals

December 21, 2012Kirsten Wallerstedt

The SEC’s Dodd-Frank conflict minerals disclosure rules may come under legal scrutiny. The U.S. Chamber of Commerce, the National Association of Manufacturers (NAM), and the Business Roundtable (BRT) petitioned the U.S. Court of Appeals for the District of Columbia Circuit to review Section 1502 of the Dodd Frank Wall Street Reform and Consumer Protection Act of 2010, concerning conflict minerals.

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Valuable resources for regulatory professionals