TLMI Provides More Guidance on PROP 65

PROP 65 Deadline Takes Effect in California – No Delay Granted

As TLMI has reported on several times this year, California’s revised PROP 65 regulations went into effect yesterday. If your company has received inquiries from suppliers or customers asking you to certify compliance with the new regulations, TLMI has provided the below outline on steps to take. In most instances, they want to understand if your label (or other product) includes one of the covered chemicals, and may be subject to the regulation. We encourage you to first read the overall backgrounder developed by the state, for an understanding of the compliance program.

Step 1: Identification of PROP 65 Chemicals
A warning requirement for a PROP 65 listed chemicals is not automatically triggered. Many of the chemicals have listed safe harbor level listed. To begin, TLMI recommends member companies review the most current list of PROP 65 chemicals, to identify whether or not their product contains a listed chemical.

Step 2: Review Exposure Limit Levels for Chemicals
California has set exposure limits for some of the chemicals listed. If the exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm, then compliance is not required.

TLMI recommends erring on the side of caution – if you do not know the presence level of a PROP 65 chemical, we suggest treating it as a covered chemical, and working to comply with your supplier and or customers.

Step 3: Understanding Responsibility for Providing the Warning
For labels impacted by the regulation (and attached to a consumer product), the distributor or manufacturer importing the product must provide the warning to the retailer. If your company is receiving letters or inquiries from customers, it is because they want to know if warnings are required for their products.

The written notice to the retailer must state that a PROP 65 warning is required and include the name, description or identifying information for the product, as well as necessary warning materials.

Just as important, the brick and mortar outlet must also provide to the manufacturer, or other entity importing covered products notification that they have received the PROP 65 warning, and all necessary safe harbor materials.

Step 4: PROP 65 Warning Label Overview

Most consumer products goods (CPGs) companies, will likely not print PROP 65 warnings on impacted products (even though that is an option). The majority will update safe harbor warnings and provide businesses that sell their products information required to be in compliance.

For companies choosing not to use on-package labeling, there must be a product-specific warning provided on posted sign, shelf tag, or shelf sign at each point of display. It may also be provided via any electronic device or process that automatically provides the warning to the purchaser, prior to or during purchase.

SpectraGraphics Inc. Adds Second Mark Andy P5

We are happy to announce that we are adding another Mark Andy press to our equipment line up.  The new unit adds much needed wider web capacity, up to 8 color UV/Water ink combinations with even more expanded content labeling options.  We have been amazed at the efficiency and printing quality these newer servo driven presses provide.

This press should come online in early to mid August.  Contact our exceptional customer service or sales teams to find out more about what this new unit could do for your business!

SpectraGraphics Inc. P5

FDA Finalizes Significant Changes to Nutrition Panel for Food and Beverages

On Friday the FDA announced updated nutritional panel information for the majority of food and beverages sold in the US. The  final requirements are a result of feedback and analysis of agency research, industry input and available scientific data. Virtually all food and beverage packaging will need to adjust their current labels as a result of the final rule.
Major changes to the current label include:
  • Highlighting “Calories,” “servings per container,” and the “Serving size” declarations by increasing the type size and placing the number of calories and the “Serving size” declaration in bold type.
  • Requiring manufacturers to declare the actual amount, in addition to percent Daily Value, of mandatory vitamins and minerals.
  • Addition of any “Added Sugars” directly beneath the listing for “Total Sugars”
  • Changing the footnote to better explain the percent Daily Value.
The new label, as provided by the FDA, is below:

 

Opponents of the new requirements believe the new label directly contradicts the FY 2016 Consolidated Appropriations Act (under which the FDA received its 2016 funding). A section of that Act prohibited the FDA from using data from the 2015 Dietary Guidelines for Americans Committee Report as part of its justification for rulemaking, unless there was significant scientific agreement.  Opponents claim no such agreement exists, therefore, the rule should be struck down by the courts and sent back to the FDA for redrafting.
Food and beverage manufacturers with sales of over $10 million annually will be required to comply with the new label requirements by July 26, 2018. Those with sales less than $10 million annually will have an additional year to comply.

Federal Mandatory GMO Labeling Bill Fails to Advance

Industry wide, food companies are preparing for the Vermont GMO labeling law (effective July 1, 2016), which requires all food products containing GMOs to be labeled.

As previously reported, federal legislation that would prohibit states from requiring mandatory labels for food products containing GMOs failed a key “test” vote last month on the Senate floor. While Congressional supporters of the bill still are pursuing avenues to advance the legislation, they’ve been unable to reach a compromise approach with bill opponents.

On Product BPA Labeling Requirements for California Nixed

On May 11th, California retailers are required to post signage at the register, warning customers that certain food and beverage packaging sold in the store may contain bisphenol-A (BPA). This was a compromise between requiring retailers to place signs on specific aisles and labeling food and beverage containers containing BPA.

The state’s Office of Environmental Health Hazards Assessment will continue to assess the science surrounding potential health impacts of BPA, however we do not anticipate required on-package labeling in the near term.

FDA Reconsiders “Healthy” Labeling Requirements

As a result of the KIND Healthy Snacks company petition, the FDA has reconsidered the term “healthy” for labeling on food and beverages.

Under the FDA’s current application of food labeling regulations, whether or not a food can be labeled “healthy” is based on specific nutrient levels, rather than its overall nutrition quality. The “healthy” labeling requirements tied to nutritional content have not changed.

What has changed is a company’s ability to label its products as “healthy” in a way that is clearly presented as a corporate philosophy, but not as a nutrient content claim. It cannot be labeled in the nutrition facts portion of the label.

Water Resources Development Act (WRDA) Contains Optional Labeling Provision

The Water Resources Development Act (WRDA) of 2016 is a key piece of legislation. The bill would authorize $9.3 billion for improvements and maintenance for ports, coastal navigation channels, river channels, canals, dams, locks and levees, as well as funding for ecosystem restoration projects and financial assistance for public drinking water and wastewater systems.

WRDA contains a “voluntary” labeling fee provision for the right of a brand/customer to place a label on their packaging stating that they are contributing to the water infrastructure fund and supporting clean water – each label would require a 3 cent per unit contribution to the Fund.

The labeling provisions would be overseen by FDA, and although not specifically stated, would likely focus on food and beverage customers who wish to participate in the right to label their products. Fees collected would be used to pay for clean water infrastructure as well as port and marine related infrastructure.

The bill also expands the existing WaterSense labeling program, currently overseen by EPA, by adding products that may qualify to carry the label should they meet program requirements.

The Senate Environment and Public Works (EPW) Committee recently passed the bill out of Committee by a 19-1 vote. Senate Republican leadership is working for floor passage this summer. The FDA would undertake a rulemaking to determine label standards, including size, recyclability and other compatibility issues.

California BPA Warning Labeling

A sub-agency within CA has decided include BPA on the Prop 65 list of chemicals known to cause cancer or reproductive toxicity.

 What’s next? After the level of BPA needed to trigger the warning is established, all consumer products that breach the established level will need to have their products appropriately labeled within 12 months.

Unlike other states, CA has demonstrated its ability to be very aggressive in enforcing issues related to statute, both with enforcement action (warnings, fines, etc.), as well as class action lawsuits against companies not in compliance, often led by trial attorneys trolling for business.

 Possible result? An influx of those companies that would be required to label, seeking the services of the label companies.

Click for a news article from Reuters on the matter.

 

Source – TLMI

FDA Targets Sugar Recommendations, Continues Moving Towards Revised Food & Beverage Label Requirements

At the end of July, the FDA issued a comment period related to individual food and beverage packaging labels, this time specific to sugar.  While sugar is already listed on food and beverage packaging, unlike other ingredients, it is not tied to an index based on a 2,000 calorie a day diet.

When the food and beverage packaging labeling are revised and finalized by the FDA, we believe that the amount of sugar recommended per day will be included.  The notice issued by the FDA for sugar is the first formal step in this regard, with a 75-day comment period that began at the Agency on July 27th.

Anticipated Compliance Date for Broader Food and Beverage Labeling – January 1, 2018

The FDA has stated that industry will need to be compliant of any regulations regarding food and beverage labeling finalized in 2015 or 2016, by January 1, 2018.

While the nutritional labeling has not yet been officially “finalized”, it is very likely to be so by the end of 2016.  Many in the industry are anticipating a final rule/decision on nutritional labeling by March 2016.

As drafted and issued by the FDA, the below image captures the latest proposal for changes to current labeling requirements.  Please note, while this image does not reference the “percentage” of sugar recommended, we anticipate that will be included in the final version.

FDA Image

If your company is interested in providing comments to the FDA on this and other proposed labeling requirements, please click here.

In addition the U.S. FDA, the Canadian Food Inspection Agency has issued a web-tool kit for industry, so companies may ensure they are in compliance with all labeling for food and beverage products.  The Tool Kit breakdowns industry labeling requirements by category, and also provides information on “health” and other claims that may be legally permitted on products.

Source – TLMI