Regulation Archives

Short answer

Yes. Levosil desiccant bags filled with silica gel and activated clay comply with the U.S. military specification MIL-D-3464E (Desiccants, Activated, Bagged, Packaging Use and Static Dehumidification), in Type I (clay) and Type II(silica gel) configurations.

Compliance is possible because our bags use adsorbent, non-deliquescent desiccants, as required by clause 3.2.1 of the standard. The Levodry Gel (calcium chloride based) meets a different requirement — protection of goods inside shipping containers — and, by its chemical nature, falls outside the scope of MIL-D-3464.

What MIL-D-3464E requires

MIL-D-3464E, issued by the U.S. Department of Defense in 1987, defines the requirements for bagged desiccants used in military and industrial packaging to prevent corrosion and mildew in enclosed spaces.

Key requirements of the standard:

Non-deliquescent material (clause 3.2.1): the desiccant must not liquefy upon water uptake.
Minimum adsorption capacity: 3.00 g of water vapor at 20% RH and 6.00 g at 40% RH, per desiccant unit, at 25 °C.
Maximum unit weight: 50 g per unit.
Reactivation: after regeneration at 118.3 °C, the bag must retain at least 90% of its original capacity.
Three classifications:
- Type I — general purpose (typically clay)
- Type II — non-dusting (typically silica gel in Tyvek®)
- Type III — specific conditions (8 and 16 units only)

Why silica gel complies and calcium chloride does not

The technical distinction is chemical and relates to how the material captures moisture.

Adsorption (silica gel, clay, molecular sieves)

Water vapor is trapped on the porous surface of each granule by physical forces. The material remains solid, dry, non-deliquescent. It can be regenerated in an oven. It meets clause 3.2.1 of MIL-D-3464E.

Absorption (calcium chloride)

Calcium chloride is deliquescent: it captures moisture and turns into a saline liquid solution, retained inside the bag by a gelling matrix and impermeable envelope. Its absorption capacity is much higher than silica gel (up to 300% of its weight), but it does not satisfy the non-deliquescence requirement of MIL-D-3464E.

This is why Levodry Gel is designed for a different reference standard: DIN 55474 (protection of goods in shipping containers) and container rain prevention practices.

Levosil compliance matrix by product family

Product	Desiccant	MIL-D-3464E	DIN 55473	REACH	UFI / CLP
Desiccant bags	Silica gel	✓ Type II	✓ Type A/B/Tyvek®	✓	Not required
Desiccant bags	Activated clay	✓ Type I	✓ Type A/B	✓	Not required
Desiccant bags	Molecular sieves	–	✓	✓	Not required
Levodry Gel	Calcium chloride	Out of scope (deliquescent)	–	✓	✓
Pharma Micro Bag	Silica gel / sieves	✓ Type II	✓ Tyvek®	✓	Not required

The UFI (Unique Formula Identifier) is mandatory since 1 January 2021 under Regulation (EU) 2017/542 and Annex VIII of the CLP, but only for mixtures classified as hazardous. Levodry Gel is notified through the ECHA PCN portal and the Italian ISS. Silica gel, clay and molecular sieve bags do not require UFI notification because they are not hazardous mixtures under the CLP.

What “MIL-D-3464 compliant” means in practice

A MIL-D-3464 compliant bag must guarantee four things:

Measurable performance — adsorption verified under standard conditions.
Chemical safety — non-deliquescent, non-corrosive toward steel, brass, aluminum, magnesium (clause 3.11).
Reusability — reactivable by oven drying.
Traceability — labeling that identifies nomenclature, specification, type, number of units, reactivation temperature and time, manufacturer.

Levosil has been manufacturing bags that meet these characteristics since 1964, from its plant in Chiusa di San Michele (Turin, Italy), with ISO 9001 and ISO 15378 (pharmaceutical primary packaging) certifications.

Levosil’s complete regulatory set

Levosil is among the few European desiccant bag manufacturers covering the full regulatory spectrum:

MIL-D-3464E (U.S. military specification) — silica gel and clay bags
DIN 55473 (German packaging desiccant standard) — Type A and B
DIN 55474 (desiccant sizing for maritime packaging) — Levodry Gel
REACH (EC Regulation 1907/2006) — all raw materials
UFI / CLP (EU Regulation 2017/542, CLP Annex VIII) — Levodry Gel notified
ISO 9001 (quality) and ISO 15378 (pharmaceutical GMP primary packaging)
FSC® Chain of Custody — certified paper for envelopes
DMF-free (Commission Decision 2009/251/EC) — declaration of conformity available

How to request the MIL-D-3464 declaration of conformity

The MIL-D-3464E declaration of conformity for Levosil bags is issued upon request, referenced to the production lot. It includes desiccant type, number of units, verified adsorption capacity, recommended reactivation temperature and time, and envelope information (Type A, Type B, Tyvek®).

You can contact us now for more information: 0039 011 96 43 430
📧 info@levosil.com

⏱ Reading time: 5 minutes

PPWR and Desiccant Bags: What Changes for Levosil

The Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) is a very broad piece of legislation, designed to regulate the life of packaging as a whole. Because of this breadth, it inevitably leaves some room for interpretation for niche products that make up only a tiny share of the packaging market. Among these are desiccant bags.

Desiccant bags are not packaging in the traditional sense. In addition, there is currently no dedicated recycling chain for desiccants, since the quantities involved do not justify one, nor is there an eco-labelling system designed specifically for these products. These elements support the view that desiccant bags may fall outside the scope of the PPWR.

To obtain a definitive view, Levosil has requested a direct opinion from the European Commission’s Directorate-General for Environment. Pending an official reply, the current position is that desiccant bags would not be subject to the PPWR. They remain, however, compliant with the part of the Regulation currently in force, in particular the substance requirements under Article 5.

Timing

As a general overview, the PPWR was published in the Official Journal of the European Union on 22 January 2025 and entered into force on 11 February 2025. It applies generally from 12 August 2026 and replaces Directive 94/62/EC. The main purpose of the European packaging regulation is to reduce the environmental impact of packaging waste by promoting a circular economy.

Levodry Gel and its classification.

The Levodry line, based on calcium chloride, would in any case follow different end-of-life rules: spent material falls under the general waste framework, not packaging waste streams. The Levodry bag still complies with the substance requirements of Article 5, regardless of the final classification outcome.

What if I use the desiccant bag inside a product?

If the bag is permanently inserted inside a product as an integral part for its entire life cycle — for example, housed permanently in equipment or a lamp — it is not considered packaging. In that configuration, the PPWR does not apply.

Timeline

11 February 2025: entry into force of the Regulation.
12 August 2026: general application; PFAS limits for food-contact packaging under Article 5(5).
1 January 2028: delegated acts on recycling design criteria and recyclability classes.
12 August 2028: harmonised labelling on material composition.
1 January 2030: obligation for recyclability in class A, B, or C; minimum recycled content in plastic parts; minimum reduction in weight and volume.

Levosil is already compliant with Article 5 of the PPWR

Regardless of the classification outcome, Levosil confirms the compliance of all its desiccant bags with the substance requirements of Article 5. The sum of lead, cadmium, mercury, and hexavalent chromium is below 100 mg/kg (100 ppm). All products are PFAS-free, and the limits applicable from 12 August 2026 are already respected for all applications. All products are free from bisphenol A (BPA), and Levosil does not use silica gel with cobalt chloride indicator.

The sizing of Levosil bags is also optimized according to DIN 55473 and DIN 55474. The amount of desiccant is calculated on the actual adsorption requirement, without excess, in line with the principle of minimizing packaging where applicable.

You can contact us now for more information: 0039 011 96 43 430

info@levosil.com

Levosil desiccant bags are compliant with MIL-D-3464